tag:blogger.com,1999:blog-73053272645330692352024-03-07T21:09:10.609-08:00pharmaceutical store managementshahzadhttp://www.blogger.com/profile/01364507074991292353noreply@blogger.comBlogger53125tag:blogger.com,1999:blog-7305327264533069235.post-32277788922946842242009-06-20T21:11:00.000-07:002009-06-20T00:10:29.715-07:00Pharmaceutical recordkeeping systemA system for recordkeeping, comprising assigning a bar code label to material to be processed including information identifying the material and successively moving the material into a plurality of processing stations. At each station the bar code label is read, a second bar code label including information relating to a processing operation is assigned to the material, the second bar code label is read, a processing operation is performed in accordance with the second bar code label and a third bar code label is assigned to the material including information corresponding to results of the processing operation. The information from the first, second and third labels are stored in a main storage device.<br />1. A method for record keeping, comprising the steps of:<br />receiving material to be processed and assigning a machine readable first data record holder to the material to be processed, including a first data record comprising information identifying the material;<br />reading the first data record holder at a quarantine station;<br />assigning a machine readable second data record at the quarantine station to samples from the material to be processed including a second data record comprising the electronic signature of an operator taking the samples and information relating to the sample requirements; and<br />reading the second data record holder at the quarantine station;<br />moving the material to be processed into a processing station and assigning a third data record holder to the material including a third data record comprising the electronic signature of an operator performing a processing operation and information relating to the results of the processing operation; and<br />storing the first, second and third data records in a main data storage device.<br />2. The method according to claim 1, wherein each step of assigning comprises printing a bar code label and attaching the label to the material. 3. The method according to claim 2, wherein each step of reading comprises scanning a bar code label with a bar code scanner. 4. The method according to claim 1, wherein each step of assigning comprises providing a portable memory device and attaching the device to the material. 5. The method according to claim 1, wherein the second and third data records further comprise a time code. 6. The method according to claim 5, wherein the step of storing comprises generating a checkcode for each data record and storing both in the main storage device. 7. The method according to claim 6, wherein the checkcode is generated by combining data bits relating to the electronic signature, data bits relating to the time code and a checksum of the data record.<br />BACKGROUND OF THE INVENTION<br />The present invention relates to a system for assuring compliance with procedures in ongoing production processes and in particular a pharmaceutical recordkeeping system.<br />Currently, many manufacturing processes are regulated by government and state agencies which set forth procedures with which manufacturers must comply in order to obtain regulatory approval for their products. For example, pharmaceutical manufacturing processes must comply with NDA/ANDA procedures and must accumulate permanent raw material and manufacturing batch processing records in compliance with FDA regulations.<br />While manufacturers have complied with these rules and regulations by manual recordkeeping, there has been a need for an automated system which can adapt to the specific needs of each manufacturer while maintaining compliance with manufacturing procedures and recordkeeping requirements.<br />SUMMARY OF THE INVENTION<br />The main object of the present invention is to provide an automated system for assuring compliance and permanent records of ongoing production processes.<br />Another object of the present invention is to improve productivity by reducing paperwork, automating data acquisition, improving materials flow and by authorizing operators under controlled and secure access conditions.<br />The system according to the present invention can be implemented into a batch processing oriented manufacturing operation for pharmaceutical manufacturing, bulk pharmaceutical chemical formulation, food and beverage processing, consumer package goods manufacture, clinical laboratory diagnostics reagent production and medical device manufacturing.<br />In accordance with the invention, data can be input via keyboard and mouse, touch screens, keypad data entry, wireless and plug-in bar code scanners and terminals and the like.<br />One feature of the present invention is the use of an electronic signature to control employee security access. Each operator is identified to the system by a name code or bar code and a password. The combination of either the name code and password or the bar code and password represents the electronic signature of the operator.<br />In accordance with the method of the present invention, sample inspections and tests insure that only those materials and product batches which meet quality standards are processed into finished product and shipped to customers. The method automatically requests the necessary samples, inspections and tests and maintains the status of the results in a database. The system will only allow those materials and product batches which have met these criteria to be processed further.<br />All data associated with a particular product batch, including all materials used in the process, are automatically assembled into a complete batch record for review prior to product distribution. The records may be reviewed in their completed state or in the sequence that the data and verification were recorded.<br />The system also utilizes redundant storage of records to insure data integrity. For example, during the performance of a blending step in the manufacturing process of a particular product, a sequential logging file would record the identification of the performing operator, the batch record file and the facility and equipment file with every operation time and date stamped. The data would be recorded in a redundant server as each step was completed to prevent data loss should a piece of workstation hardware fail.<br />Furthermore, each data entry in the system generates a unique check code. The check code permanently binds an electronic signature to the event. As part of the system, background programs check the recorded data and the check codes and these check codes not only verify that the data stored and retrieved is identical, but it also looks for inconsistent or unauthorized modifications of the records. Should a discrepancy be detected, it will be reported to a system manager.<br />All data recorded in the system can be archived on unalterable compact disk write-once read-many media. The timing of the periodic archiving is controlled by the system and types of data to be archived include sequential event logging, completed material lot histories, completed batch records and document revision histories.<br />Under the control of the system, certain operators can be limited to using one particular workstation. Each significant event performed on the system is recorded in the database with a date and time stamp and the identification electronic signature of the individual performing the event.<br />The present invention makes full use of bar coded labels, with comprehensive tracking and verification of materials from receipt, through inprocessed batches, to packaged product and shipping. Movements and status are monitored in accordance with the present invention and controlled. Unique material lot numbers are generated and bar coded labels are printed to identify each container. Prompts and bar coded labels are provided for material sampling, sample inspections and tests in quality control review accepts or rejects material and the location of material is established with bar coded warehouse rack and aisle designations.<br />Unique batch numbers are generated on bar code labels and withdrawal and dispensing of materials are prompted in accordance with released batch production control records. Materials are automatically allocated to each batch on a first-in/first-out basis or by specific allocation through management intervention. Prompts and bar coded labels provide for dispense material and batch identification, with automatic material inventory level update. There is automatic reconciliation of material lot weight or measures after depletion and bar coded labels are generated for all inprocess product and sample containers.<br />The scanning of container bar code labels provides the system of the present invention with the ability to track and verify the materials and batches by their lot and batch numbers. The system alerts operators if they attempt to move or use materials incorrectly. Wireless or plug-in palm top bar code scanners and terminals allow this verification to be implemented in larger areas, such as a warehouse, and the reconciliation of material lot total weights and measures with specific attention to product labels and printed containers is performed by the system.<br />The system also handles material dispensing and recipe tracking. Material is delivered to local inventory and, after reading or generating the bar coded data describing the materials, the dispensing process is initiated. The system acts to insure that equipment, room, personnel and container rules are observed. As each step is undertaken, the system can verify that the recipe and its constraints are not violated.<br />The system verifies that material delivered to local inventory with potency data is in accordance with the equation relating weight or volume to potency. The system can alert the operator if materials do not meet required tolerances or if dispensed material does not fall within the allowed weight ranges. The system can provide multiple dispensing of a single ingredient for a single batch where the ingredient is mixed in different stages.<br />The system identifies dispensed ingredients and quality control samples when required with bar codes and specifies quarantine or acceptance. Material to be returned to the warehouse, local inventory, special storage, waste or which has outlived its shelf life is routed as required.<br />The system can only proceed once prescribed data, personnel identification or electronic signature entries, as defined by management have been made at the time of completion of a process step. Alerts can be provided by the system when incorrect responses are received, with the option to require a second party intervention to correct an entry. Thus the system insures data integrity and compliance with defined procedures.<br />These and other objects of the present invention are also achieved in accordance with the present invention by the use of a system comprising portable memory devices (PMD's) and associated stations having read/write equipment to document process requirements and permanently record process data, all under the control of a main processor. The PMD's are secure, serialized, non-alterable electronic tags which travel with the materials or manufacturing batches. Data is permanently written into the "write once read many" memory in the PMD. An example of a device which is useful for this purpose is the Fujitsu MB98A6070, MB98A6080, MB98A6090 and MB98A6100 one time programmable read only memory card. Once data has been written into the PMD, the data cannot be altered, but, can be read as many times as necessary thereafter. Additional data can be sequentially added to the PMD, up to the memory capacity of the PMD.<br />In accordance with the invention, master production and control procedures and requirements are entered into a PMD when manufacturing is initiated. The identification and process record data required by the FDA, is written into the PMD's on a real time basis for comparison with the process requirements and the permanent archiving of actual process data. The data is written into and retrieved from the PMD's using stationary or handheld read/write equipment at each process station. There are two different types of PMD's available. One type uses a radio frequency or electromagnetic signal to communicate with the PMD during the read/write functions. The other type of PMD plugs directly into the read/write equipment, making a direct electrical connection for communications. Management of the recorded data is controlled by a main processor linked to each station by a bus or network connection. The main processor controls the security and accessibility to the data in each PMD, performs data comparisons for verification of materials, products, equipment, test samples and controlled parameters contained within each PMD to provide alerts in the event of errors. The main processor provides an index of the PMD's and can also assemble and format a printout of the stored data for review and evaluation at a later time.<br />In a particularly advantageous commercial embodiment of the present invention, a pharmaceutical manufacturing system can be implemented wherein individual PMD's are assigned to each lot of raw material upon receipt by the manufacturer. The specific material identification, receipt date, weight or measure, unique lot number and a delineation of all sample test requirements for final acceptance are written into the PMD for each lot. When samples are withdrawn from the material lot for acceptance tests, intermediary PMD's are assigned to each sample to assure correlation of the samples to the material in quarantine. The specific material identification and test requirements are read from the raw material PMD and written into the sample PMD. The sample PMD then travels with the sample of material through the completion of the testing. Test pass or fail notations are written into the sample PMD by the test laboratory at the specific station and the sample PMD is returned to the raw material quarantine area for correlation with the original material PMD through a dual read and compare routine. Following this routine, the test results are read from the sample PMD and written into the correct raw material PMD. The sample PMD can then be reused for the sampling of other raw material, or archived when the memory capacity has been exhausted.<br />When all material acceptance requirements have been satisfied, the raw material PMD is again written into to indicate that the material is accepted and the raw material, together with its raw material PMD, is moved together out of quarantine and into usable stock.<br />The system is also used in the dispensing of raw materials for the manufacturing processes. Manufacturing components are requested from the raw material in usable stock via a PMD containing the identification of the manufacturing batch and the specifics of the requested raw material. The application of a dual read and compare routine to the requesting manufacturing component PMD and the raw material PMD assures positive correlation between the requested material and the actual material that is dispensed.<br />The specific manufacturing batch identification and dispensed weight or measure are written into the raw material PMD each time material is dispensed or issued. Likewise, the raw material lot identification and dispensed weight or measure are written into the manufacturing component PMD for return to the manufacturing process along with the dispensed material.<br />Other information is added to the PMD's at various times during the process and annotations of the date and time, the identification of the performing and verifying individuals and traceable references to any problem investigations, represent some of the additional data included in the PMD.<br />When the lot of raw material has been exhausted, reconciliation of the dispensed versus the total received weight or measure may be performed since the raw material PMD contains a complete and unalterable history of the specific lot of raw material. The raw material PMD is then archived for later retrieval of data for the duration of the required FDA retention period. If sufficient unused memory capacity remains, the PMD may be used for additional lots of raw material before being retired to the archives.<br />In manufacturing, two PMD's are assigned to each manufacturing batch at the time of production authorization. One PMD, the manufacturing PMD, is formatted with the specific product and batch identification, along with a reproduction of the complete master process and control requirements for the product. The second PMD, the component PMD, is formatted with some of the same information, however, with specific annotations with all of the material components required during the manufacturing process.<br />As the manufacturing process is implemented, actual process information is recording on the manufacturing PMD. This information includes the equipment used, the yields obtained and compliance with specific process limitations such as time, temperature and speed. Comparison routines verify the actual data with the established master production and control requirements or limits and can alert the operator to the need to resolve any discrepancies.<br />As described with regard to the raw material, intermediary samples PMD's can be used for the manufacturing in process sample tests. The sampling requirements are written from the manufacturing PMD into the sample PMD when the sample is required. Later, the results of the sample testing are written from the sample PMD into the manufacturing PMD upon successful completion of each test.<br />The associated component PMD is used and actually moves between the manufacturing process and the stock room, to verify the dispensing of the required material. As with the correlation of the requested and dispensed raw material heretofore described, the component PMD also provides positive assurance that the correct material is used in the manufacturing process. The dual read and compare routine is applied to both the component and manufacturing PMD's upon return of the dispensed material from the stock room and before introduction of the raw material into the manufacturing process.<br />Other required information can also be added to the manufacturing and component PMD's at various times during the process, including verifications to proceed and final acceptance of the product by quality assurance.<br />Assuming bulk product is completed and held for later packaging, two new PMD's are assigned to each packaging lot. These PMD's are used in the same manner as the manufacturing and component PMD's to control and monitor the packaging process and materials. Product distribution may be added to the packaging PMD as the product is shipped.<br />The bulk manufacturing and packaging PMD's contain a complete unalterable history of the process, including verification of compliance with the requirements of the master production and control record. These PMD's are then archived after depletion of the batch of bulk production and completion of finished product inspections, record reviews and distribution of the packaged products for FDA record review in the future. If sufficient unused memory capacity remains, the manufacturing and packaging PMD's may be used for additional batches before being retired to the archives.<br />Each PMD contains a unique, permanently recorded, serial number in the memory. The additional permanently recorded cross referencing of material lot numbers, manufacturing batch numbers, and the PMD serial numbers in companion PMD's, make it virtually impossible to covertly alter or destroy actual recorded historical data. Therefore, the invention prevents undetected data tampering and an extremely high level of archive data security.<br />Throughout the raw material and manufacturing processing, the PMD data is periodically accessed and stored in a database in the main processor for appropriate analysis. A cross referenced index of the PMD's is established, updated, and maintained in the database of the main processor to facilitate the location of specific archived material or product batch data.<br />DETAILED DESCRIPTION OF THE INVENTION<br />Referring now to FIGS. 1-5, a preferred embodiment of the present invention is described with reference to a system for producing pharmaceutical products. It is understood by those skilled in the art that the present invention can be adapted to other processes where high levels of security and preventing the tampering of records is required.<br />A main processor 15 is connected to a plurality of stations 1-12 via bus 16. Stations 1-12 interact with a plurality of portable memory devices (PMD's) 21-29 by means of electronic signals or electromagnetic waves. The PMD's 21-29, for example, may have up to 1 mb of storage and can be written into and read out from via electronic signals or electromagnetic waves transmitted from stations 1-12 to PMD's 21-29 and received from PMD's 21-29 at stations 1-12 which are stationary or handheld read/write devices. Examples of PMD's and stations are disclosed in U.S. Pat. Nos. 4,242,663, 4,549,264 and 4,724,427, the disclosures of which are hereby incorporated by reference.<br />The main processor 15 includes a microprocessor and main memory which receives data from stations 1-12 and sends data to stations 1-12 for transmittal to the PMD's 2129. Main processor 15 is preferably a microcomputer having an Intel microprocessor, such as the 80486 or a Macintosh computer based on a Motorola microprocessor.<br />The first stage of a pharmaceutical manufacturing process involves the reception and acceptance of raw material which is to be used to manufacture a product. When raw material is received at station 1, the name and code of the material, as well as the date, weight or measure and vendor of the raw material is entered into the memory of the main processor 15. At that time in step 101, a raw material PMD 21 is assigned to the lot of raw material and is formatted by main processor 15. The raw material PMD has data written into it from a database in main processor 15 in step 102 via station 1 and this information includes the material name and code, the material lot number, the vendor, the acceptance requirements including the sample required, examination and test required, as well as the criteria for the test, the date received, the total weight or measure and reconciliation limits.<br />The lot with the raw material PMD 21 is moved into quarantine at station 2 in step 103 whereupon samples are removed for various acceptance tests in step 104. Each sample has a sample PMD 22 assigned to it. Under the control of the main processor 15, data from the raw material PMD is written into the sample PMD's in step 105 including the material name and code, the material lot number, the sample required, the required tests and criteria, the sample date, the I.D. of the person taking the sample.<br />The samples are moved to station 3 where the tests are conducted in step 106 and each test PMD 22 has data written into it in step 107 reflecting whether or not it passed or failed its particular test, the I.D. of the person making the test and the date of the test.<br />The sample PMD's 22 are then moved back to station 2 whereupon a dual read and compare is performed in step 108 wherein main processor 15 verifies that common data is read from the sample PMD 22 and the raw material PMD 21 specifically relating to the material name and code and the material and lot number. Upon verification, the data relating to the tests are written from the sample PMD into the raw material PMD in step 109 including the sample date, sampling person I.D., whether the test was passed or not, the test person I.D. and test date.<br />Based upon the results of the test, the raw material must either be accepted or rejected. This acceptance or rejection is written into the raw material PMD in steps 110 or 111, as well as the identification of the person making the decision. If the material is rejected, it is kept in quarantine or disposed of in step 111. If the material is accepted, the lot of raw material is placed in usable stock.<br />The manufacturing process uses components of raw materials which have been accepted and placed in usable stock.<br />In the bulk manufacturing process, initially two PMD's are assigned for a product in step 121. The first PMD is a batch manufacturing PMD 24 and the second PMD is a batch component PMD 23. At station 5, the manufacturing PMD 24 is formatted by the main processor 15 which writes into the manufacturing PMD in step 122, product identification including the product name and code, the strength or dosage of the product, the batch size, the batch lot number and the master production and control for the processing including each step of the production, as well as the process requirements for each step. These requirements include the equipment to be used, the process theoretical yield and acceptable tolerances, and process limitations including tolerances on time, temperature and speed. The in-process test requirements including the number of samples required, the tests required, and their criteria are also recorded.<br />The component PMD 23 is formatted by main processor 15 which writes into it in step 123 the product identification and master production and control data including for each step, the material required including the active ingredients identified by material name and code and weight or measure required and the same information for any components of the product being manufactured.<br />When the order is released for production, the date and the electronic signature of the release person is written into the manufacturing PMD and the component PMD.<br />Component PMD 23 is then moved to station 4 where raw material and raw material PMD 21 are located. A dual read and compare is performed in step 124 between the component PMD and the raw material PMD to verify a common material name and code. Upon verification, the material lot number and the acceptance of the material is read from the raw material PMD and written into the component PMD in step 125. The product identification information is read from the component PMD and written into the raw material PMD. Furthermore, the amount of material dispensed is indicated in the raw material PMD so that a reconciliation can be performed in the main processor 15. The main processor, upon determining that the first raw material has been dispensed, will indicate to an operator that another raw material is needed at station 4, and the steps 124 and 125 will be repeated until all of the required materials have been dispensed.<br />The component PMD then returns to station 5 for the first step of the manufacturing process. Before the first process step is performed, a dual read and compare operation is performed in step 126 between the component PMD and the manufacturing PMD to verify that common product identification and common master production and control data are contained on the two PMD's.<br />At this time, various process steps are performed to manufacture the product. For each process step, the dual read and compare operation is performed as further material components are added. Moreover, data is written into the manufacturing PMD for each process step including the fact that material has been dispensed and verified, the equipment that is used, the start time and date, actual yield and whether the yield was within the limits, completion time and whether the completion time was within the limits, the process operator I.D., and the supervisor I.D.<br />After the process step, the batch is moved to station 6 in step 127 where samples are withdrawn and sample PMD's 25 are provided for each sample. Data is read from the manufacturing PMD and written into the sample PMD in step 128 including product identification, the step number, the sample required, the test required and the criteria.<br />The tests are performed at station 7 in step 129 and data is written into each sample PMD in step 130 including the sample date, the I.D. of the person taking the sample, whether or not the test was passed, the I.D. of the person administering the test and the date of the test.<br />The sample PMD is returned to station 6 where a dual read and compare is performed in step 131 with the manufacturing PMD to verify that common data relating to the product identification and the master production and control is present. Upon verification, data relating to the sample and test is read from the sample PMD and written into the manufacturing PMD in step 132. Based upon the test data, the sample is noted as having been completed and accepted and the acceptance and the I.D. of the person making this acceptance is written into the manufacturing PMD in step 133.<br />The product batch, manufacturing PMD, and component PMD are then moved to station 5 for the next step in the process and steps 124-133 are repeated for each process step.<br />In the last step of the manufacturing process, the component PMD can be used to obtain capsules for encapsulating the finished product. The component PMD would include for this last step the capsule requirements and the material would be encapsulated at station 5. The same testing can be performed at station 6 and station 7 before the finished bulk product is finally approved and accepted for packaging in step 134.<br />At this time, the product packaging PMD 26, and packaging component PMD 27, are assigned in step 141. These new PMD's have similar purposes to the manufacturing PMD 24, and the manufacturing component PMD 23, described earlier. The main processor 15 formats the product packaging PMD 26 at station 8 and writes data therein in step 142 including product identification, product name and code, strength and dosage, packaging lot number, package quantity, content quantity, packaging requirements including containers, seals, and labeling requirements, and the final product sampling test requirements. The packaging component PMD 27 is formatted in step 143 with the same product identification information and the specific requirements for packaging materials, labels, and the bulk manufactured product weight or measure. When the packaging process lot is released, this fact is written into the product packaging and packaging component PMD's including the date and electronic signature of the person making the release.<br />The packaging component PMD 27 moves between stations 8 and 9, as in the case of the manufacturing component PMD which moved between stations 4 and 5, to obtain the accepted bulk product and packaging materials form stock. First, the packaging component PMD 27 is correlated with the bulk manufacturing PMD 24 using the dual read and compare routine at station 9. The manufacturing batch identification is read from the manufacturing PMD and written into the packaging component PMD, and the packaging lot identification is read from the packaging component PMD and written into the manufacturing PMD.<br />The packaging component PMD 27 is used again in step 145 to correlate with the packaging material PMD 28 at station 9 to verify the correct materials and transfer the identification information between the PMD's. The packaging material PMD is similar to the raw material PMD in function. The packaging components and packaging component PMD return to station 8, and are correlated with the product packaging PMD in step 146 using the dual read and compare routine.<br />The product is packaged in step 147 and the packaging process parameters are recorded in the product packaging PMD along with the date and packaging person I.D.<br />After the product is finally packaged in step 147, it must be labeled.<br />Labels maintained in stock have a label stock PMD 28 associated therewith which includes label identification including product name, strength, dosage form, content quantity and label lot number, whether the labels have been accepted, the date labels were received, the total quantity received and information relating to reconciliation.<br />The packaging component PMD 27 is used when labels are obtained from the label stock by first doing a dual read and compare with the label stock PMD at station 11 in step 151 to verify the product identification information on both. Upon verification, the label lot number and the fact that the labels were accepted is written into the packaging component PMD 27 in step 152 from the label stock PMD in station 11. Moreover, the quantity of labels dispensed and the I.D. of the person doing the dispensing is written into the packaging material PMD.<br />The information in the packaging component PMD 27 relating to the batch number of the product and the quantity of labels dispensed is read from the packaging component PMD and written into the label stock PMD in step 153.<br />The labels and the packaging component PMD 27 return to station 10 and are correlated with the product packaging PMD 26 using the dual read and compare routine. The labeling is performed in step 155 and the product packaging PMD is updated with the identification of the labeling person and the labeling meet the requirements thereof. The packaging component PMD is annotated with the returned and destroyed labels. The returned labels and the packaging component PMD move back to station 11 to update the label stock PMD with the returned and destroyed label data to provide for positive label stock reconciliation.<br />After the labeling is completed, in step 156 a product sample PMD 29 is formatted by writing the product identification, sample quantity required and the required tests from the product packaging PMD. The product sample PMD travels with the product sample which is thereafter tested at station 12 in step 157 and returned to station 10 where a dual read and compare is performed in step 158 to verify the product identification codes on the product sample PMD and the product packaging PMD. The product inspection data which was written into the product sample PMD during inspection, is then written from the product sample PMD into the product packaging PMD in step 159.<br />For each recording of data into the PMD's described above, there is preferably a later transfer of that data from the PMD into the main processor 15.<br />In accordance with the invention shown in FIG. 6, each receiving station includes a computer terminal 40, a bar code label printer 41 controlled by the terminal and a bar code scanner 42 which inputs data into the terminal.<br />In one embodiment of the present invention, the system includes a receiving station 43A, a quarantine station 43B, a test station 43C, a warehouse storage area 43D, a dispensing station 43E, a manufacturing station 43F, process sampling station 43G, a packaging station 43H, a product quarantine station 43I and a shipping station 43J. All of the stations are connected via a bus to main computer 44 which is connected to a compact disk archiving system 45 and a checkcode circuit 46.<br />Each entry made at each computer terminal 40 is only permitted after an operator enters an electronic signature which includes a name code or bar code identifying the operator and a password. This information, along with a time and date stamp from the computer terminal, is sent over the bus to the main computer 44. All data to be stored in main computer 44 is first applied to the checkcode circuit which generates a word to be stored along with the data which is representative of the data, the time and date that the data was sent to the main computer for storage and the electronic signature of the operator. In one embodiment of the present invention, the check code generator generates a first group of encrypted data bits corresponding to the operator and unique to that operator, a second group of encrypted data bits representative of the time and date and a third group of bits corresponding to a check sum of the digits of the data. This word is stored in memory with the data itself. Any attempt by a person to change the data in the data word would result in an error being detected. Moreover, any change to the check code would enable the system to determine that the change was made by an unauthorized person or at a date inconsistent with the operation performed.<br />In the embodiment of the present invention shown in FIG. 7, lot data is received in step 51 and a bar code label is printed in receiving station 43A in step 52. The lot is then sent to quarantine station 43B in step 54 and a bar code label is printed with the sample requirements in step 55. The labels on the lot are read in step 56 in test station 43C wherein samples are removed and tested in step 57. A bar code label with the location number to release the lot is generated in step 58 and the lot is then stored in warehouse 43D in step 59.<br />When a lot is requested from a location in the warehouse in step 60, the material is received in a dispensing station 43E in step 61. At that time, the labels on the material are read in step 62 and material request bar code labels are printed in step 63. The materials are received in a manufacturing station 43F in step 64 and labels are read in step 65. The manufacturing steps are performed in step 66 and bar code labels corresponding to the results of those steps are printed in step 67 and applied to the materials.<br />The labels are read in test or sampling station 43G in step 68 and the test results are reported in step 69 with a bar code label printed for the test procedure in step 70.<br />The tested material then has packaging requirement bar code labels printed in step 71 and these labels on the materials are read at packaging station 43H in step 72 wherein packaging steps 73 are performed. Product bar code labels are printed in step 74 and the product is received in a quarantine station 43I in step 75. The labels are read in the quarantine station in step 76 and samples are inspected in step 77 and release bar code labels are printed in step 78. The labels are then read at shipping station 43j in step 79 and shipping labels are printed in step 80.<br />Along the way the data for each of the bar code labels is stored in main computer 44 and thereafter archived on a computer disk in the CD archive system 45 after having the checkcode for each data word generated in the checkcode circuit 46.<br />It is understood that the embodiments described hereinabove are merely illustrative and are not intended to limit the scope of the invention. It is realized that various changes, alterations, rearrangements and modifications can be made by those skilled in the art without substantially departing from the spirit and scope of the present invention.shahzadhttp://www.blogger.com/profile/01364507074991292353noreply@blogger.comtag:blogger.com,1999:blog-7305327264533069235.post-91071950401165028212009-06-18T23:22:00.000-07:002009-06-18T23:23:43.894-07:00Complaints handling and product recall1- Complaints handling:<br />1- The establishment’s management should be put in a place a written procedure for the handling of complaints which clarify procedures to be followed for information collection, investigating facts and follow up corrective actions. A distinction should be made between complaints about a product or its packaging and those relating to distribution.<br />2- In the case of a complaint about the quality of a product or its packaging the original manufacturer and/or marketing authorization holder should be informed as soon as possible and not wait until full investigation is performed.<br />3- Any received complaint, investigation carried out and their results should be documented.<br />4- To consider the possibility of recurrence of the same defect at other batches for the same when investigating any quality complaint.<br />5- There should be a written documented procedure in place for procedures to be followed in case of possible investigation results reached and actions to be taken through classifying type of results according to level of hazards that could be caused.<br />2-Recalled products:<br />1- Recalled products for quality reasons should be handled according to approved and documented procedures.<br />2- A qualified person should be appointed to be in charge of recall or pull out procedures.<br />3- Set procedures and arrangements should guarantee prompt and effective actions in case that a suspected quality defect which requires recall and suspension of batch/es is proven to be true.<br />4- All records that document the followed procedures, taken actions and recalled quantities with the required data should be readily available. These records should contain sufficient information on pharmaceutical products recalled (brand name, INN name, strength, batch number, entities that product was recalled from )signed by persons in charge for each entity involved.<br />5- All recalled pharmaceutical products and materials should be kept in quarantine area, and care should be given not to be restored with the stock approved for sale. Its release and reselling could be done only after being approved by a qualified person in charged based on proper evaluation and quality control testing. In case a quality defect is proven the recalled stock should be labeled as rejected and segregated in the rejected items area.<br /><br />6- Any disposal for any rejected items by any means (destruction or re-export, etc..) should be done only after taking the permission of Drug Control Department at MOH. This requires submitting a documented proves and relevant certificates including the quantities, specifications of the concerned rejected goods signed by persons which approved the rejection.<br />3- Goods’ Return from distribution points:<br />1- In case that any quantity of products or materials were returned for reasons related to any quality defect and it was proven that this defect is related to the quality of the products or its packaging then the case should be dealt with as mentioned in the second paragraph of the current chapter.<br />2- In case that any quantity of a product or materials were returned for a reason related to distribution operations, a full investigation should be carried out. If the investigations realized that returned goods are considered not suitable for reissue or reuse, the second paragraph of the current chapter should be applicable.<br />3- In case products are returned for pure commercial reason of no relation to the product’s quality the following instructions should be followed:<br />a- All returned products or materials should be kept in quarantine area. Its release and reselling could be done only after being approved by a qualified person in charged based on proper evaluation and quality control testing.<br />b- Any reissued stock should be labeled and to add its data within stock records.<br />c- Any products directly returned by patients (end users) through retail pharmacies should not be reissued to be stored with the approved for sale stock. Such products should be kept within rejected items area ready for disposal.<br />4- Handling of counterfeit products 1- Any counterfeit or suspected counterfeit medicines found in the pharmaceutical supply chain should be confiscated and segregated immediately in the rejected items area from other pharmaceutical products and recorded. Such products should be clearly labeled in order to prevent further distribution or sale. All confiscated quantities should be secured in a manner that prevents misappropriation and theft, were these items will be considered as a responsibility of the designated person in charge, this requires his signing for all relevant data records.<br />2- The holder of the marketing authorization, relevant official authorities and Drug Control Department, should be informed immediately. A full detailed report of the case in hand, attached with photos for the inner and outside packaging and the dosage form<br /><br />unit along with representative samples should be submitted to be checked and analyzed by the Drug control Dept. 3- Upon confirmation of the product being counterfeit a formal decision should be taken on the disposal of counterfeit pharmaceutical products and the decision recorded under the supervision and control of the relevant authorities.shahzadhttp://www.blogger.com/profile/01364507074991292353noreply@blogger.comtag:blogger.com,1999:blog-7305327264533069235.post-36440127918893207242009-06-18T23:20:00.000-07:002009-06-18T23:22:27.989-07:001- Instructions for receiving supplied materials or products: 1- On receipt each incoming consignment and their invoices should be checked to match against the relevant purchase order made by the establishment in regard with all specifications (quantities, batch numbers etc.). Each container should be physically verified to ensure its compliance with all legal and regulations given as label description, expiry date , batch numbers quantities , etc…) 2- Each container received should be carefully inspected for uniformity of containers, any clear defects, for possible, tampering and damage. In case of any suspect containers or, if necessary, the entire delivery should be quarantined for further investigation. 3- Received Items or goods should be subdivided according to brand, the supplier’s batch number should the delivery comprise more than one batch in all the storage areas (Quarantine and final storage area). 4- In warehouses where samples of the received goods should be drawn (Manufacturing sites warehouses and similar establishments), the sampling should be carried out by competent and trained personnel. 5- Received consignments should be kept at the quarantine area until ensuring its compliance with all technical specifications required based on either quality control lab reports, an authorized official legal release or rejection is obtained. 6-Effective measures should be in place to ensure that rejected; defected or expired materials and pharmaceutical products cannot be used or bypassed. They should be stored separately from other materials and pharmaceutical products while awaiting their disposal either by destruction or return to the supplier. 2- Stock Rotation and control.<br />1- Periodic stock reconciliation should be performed by comparing the actual and recorded stocks.<br />2- All significant stock discrepancies should be investigated as a check against inadvertent mix-ups and/or incorrect issue.<br /><br />3- In case of partly used containers , should be securely re-closed and resealed to prevent spoilage and/or contamination during subsequent storage. Care should be taken to use first Containers which have been opened or partly used before those in unopened containers.<br />4- Damaged containers should not be issued unless the quality of the material has been shown to be unaffected.<br />5- Regular checks should be carried out for all stocks to identify and remove obsolete and outdated materials or products.<br />3- Stock Dispatch procedures and instructions:<br />1- The concerned management should establish and endorse written standardized procedures for dispatching and handling of stock taking into account the nature of the materials and products for any special precautions might be required.<br />2- Care should be taken on selling or distributing pharmaceutical products only to parties or entities that are legally licensed and entitled to acquire such products. Written proof of such entitlement must be obtained prior to the dispatch of products to any party.<br />3- Measures should be taken to only dispatch those batches of a valid quality certificate available. This certificate based on approved quality control testing should ensure the compliance of the batch with pre-set specifications according to recognized scientific references. If such a proof doesn’t exist or the batch is out of specifications then the establishment should refrain from its selling or distribution. In such a case the establishment should transfer all quantities of that batch to quarantine and apply the quarantined stock procedures in hand.<br />4- The establishment should refrain from selling, distribution or dealing with any material or product after their expiry date or so close to the expiry date that this date is likely to occur before the products are used by the receiving party.<br />5- The dispatch of pharmaceutical products should be commenced only after the receipt of a valid and documented delivery order.<br />6- Records for the dispatch of material and products should be prepared and should include at least the following information:<br /> date of dispatch<br /> name, address and status of the intermediate (if applicable) and final receiver (e.g. retail pharmacy, hospital, community clinic)<br /> A description of the products including, e.g. brand name, INN name, dosage form, strength (if applicable), packing and presentation of pack units size of pack unit and number of units per pack.<br /> Quantity of the products, i.e. number of containers and quantity and size per container.<br /> assigned batch number and expiry date or retest date for starting materials<br /> required transport and storage conditions<br /> Unique serial number to allow identification and traceability of the delivery order.<br /><br />7- Records of dispatch should contain enough information to enable traceability of the pharmaceutical product from the point of its dispatch by the manufacturer until reach of the final user. Such records should facilitate the recall of a batch of a product from markets or users if necessary. The records and documents of the received and dispatched consignments should be available and kept in a way that enables its quick review on need or on the request of relevant official authorities.<br />8- Each party involved in the distribution chain has a responsibility to ensure traceability for dispatched materials or products.<br />9- Transportation and delivery of consignments to the receiving party should only be carried out only after taking in and checking receiving orders to be matched against dispatch orders which should be kept as part of documentation.<br />10- The dispatching party should ensure that the receiving party owns the required resources and is capable of storing the received consignment in a manner that preserves its quality. Delivered quantities should be proportionate to the storage area size provided by the receiving party.<br />4- TRANSPORTATION AND PRODUCTS IN TRANSIT<br />1. Materials and pharmaceutical products should be transported in such a manner that doesn’t allow:<br /> The loss of their identity.<br /> Its contamination by weather, surrounding environment r by other products.<br /> Its spillage, breakage or spoilage.<br /> Misappropriation and theft.<br /> Exceeding of appropriate temperature and relative humidity conditions in the case of pharmaceutical products, as appropriate which could negatively affect the quality.<br />2. Packaging materials and transportation containers should be of certain specifications and organized throughout shipping process in manner which provides protection for the shipped goods from external factors and prevent damage of pharmaceutical products during transport.<br />3. To ensure communicating all relevant conditions and precautions for storage and transportation to the entity(-ies) responsible for the transportation of pharmaceutical products.<br />4. Transportation for material and pharmaceutical products should be carried carefully in a manner that corresponds to the special storage precautions for each product’s nature:<br /> Care should be given for products that require special precautions such as radioactive, flammable or internationally controlled substances. Security and safety should be provided through validated procedures.<br /><br /> In case of shipping rejected, counterfeit or expired products, transported items should be clearly labeled to how its status and should be secured against tampering or theft.<br />5. transported consignment components should be labeled and documented with their storage requirements to be followed during transportation.<br />6. Proper and identifying documents should be accompanied during transportation available for review by authorities or similar entities.<br />7. The transporting vehicle or containers should be effectively cleaned according to the approved and validated written standard operation procedures prior to its loading Extra care should be taken when designing delivery schedules, loading and unloading in order to prevent possible physical damage (Ex: to organize bigger containers and those to be delivered later in the back and so on).<br />8. Storage conditions as temperature degrees should be recorded periodically. Such records should be available for review on request.<br />9. Special care should be used when using dry ice in containers. It must be ensured that the pharmaceutical product does not come into contact with the dry ice, as it may have an adverse effect on the quality of the product due to freezing.<br />10. Any case of spoilage or breakage should be reported by a documented report to the receiving party and to the dispatching party. use it can effect the stability of some them due to freezingshahzadhttp://www.blogger.com/profile/01364507074991292353noreply@blogger.comtag:blogger.com,1999:blog-7305327264533069235.post-20426938364953894852009-06-18T23:18:00.000-07:002009-06-18T23:19:39.730-07:00Quality Management and documentation1- Quality Management:<br />1-1 There should be a documented quality policy describing the overall intentions and policies of the establishment regarding quality, as formally expressed and authorized by upper management.<br />1-2 Quality management should include:<br /> Appropriate infrastructure or “quality system”, encompassing the organizational structure, procedures, processes and resources; and<br /> Systematic actions necessary to ensure adequate confidence that a product (or service) and documentation will satisfy given requirements for quality. The totality of these actions is termed “quality assurance”.<br />1-3 Where electronic commerce (e-commerce) is used, defined procedures and adequate systems should be in place to ensure traceability and confidence in the quality of Materials and pharmaceutical products.<br />2- Documentation: instructions, written SOPs and records: 2-1 Good documentation is essential part of Good Distribution and storage practice. Documenting working actions main objectives are to avoid errors or misjudgments, to be sure that the same (consistent) methods are used at each time, to make sure that the used instruments are working properly according to set standards and to ensure recording of all steps (actions) followed on receiving and storing of the materials and products. 2-2 written standardized work procedures (SOP), instructions and records should be:<br /> Available for review<br /> To clearly explain work procedures.<br /> To include and document all activities and procedures followed in the storage premises.<br /> To clearly identify the distribution channels for materials and products.<br />2-3 among others, written standardized operation procedures (SOP) should be in place for the following:<br /> Dealing with expired stock<br /> Procedures to be followed in case of RECALL of any products.<br /> Authorized procurement and release procedures should be in place, to ensure that appropriate pharmaceutical products are sourced from approved, legitimate and licensed suppliers and distributed by approved legitimate entities.<br /><br />2-4 there should be written procedures and records to ensure traceability of the products distributed from the point of production by the manufacturer covering all entities in the supply chain as they should be traceable as applicable until it reaches the final user. All information and details in this regard should be recorded and documented in a meaningful manner for concerned official authorities (Customs, Drug Control Dept…) as well as for other parties within distribution channels and final user. 2-5 A data Sheet of permanent information, written or electronic, should exist for each stored material or product indicating:<br /> Brand name, International Non-Proprietary Name (INN) name/s<br /> recommended storage conditions,<br /> any precautions to be observed<br /> retest dates<br /> Pharmacopoeial requirements<br /> Art work of labels and containers.<br /> Safety and first aid instructions.<br />2-6 Records should be kept for each delivery and must be retained for a period equal to the shelf-life of the incoming materials and products, where applicable, plus 1 year). They should include the following:<br /> description of the received goods ( Pharmaceutical Dosage form, size and presentation of pack unit, number of units per pack, and any other important detail like supplementary accessories and so)<br /> quality<br /> quantity<br /> supplier<br /> supplier’s batch number<br /> the date of receipt<br /> assigned batch number<br /> Expiry date.<br />2-7 Comprehensive records should be maintained showing all receipts and relevant invoices, including purchase orders and issues of materials and pharmaceutical products according to a specified system, e.g. by batch number, stock cards…<br /><br />3- Labeling<br />1- Labels applied to containers should be clear, unambiguous, permanently fixed to the container and be indelible. The labeling should be written in a language which is understood by persons involved in the distribution chain as well for relevant official authorities. 2- All containers and packaged stored material or products should be labeled clearly. 3- Labels on secondary packaging should include at least the following:<br />- Material or product name (Brand name if applicable and the INN name in addition to pharmacopeias if applicable)<br />- Quantity (weight, size, unit number)<br />- Batch number<br />- Expiry date or retest date for active ingredients.<br />- Receiving date<br />- Production date<br />- Quality Control section approval and release date with signature of person in charge.<br />- Storage conditions (clear and specific)<br />- Transportation conditions and precautions.<br />- Handling precautions<br />- Manufacturer name with its trade mark.<br />- Supplier’s name (in case it is a wholesaler or so) with contact details.<br />- When used, only internationally and/or nationally accepted abbreviations, names or codes should be used in the labeling of containers. Use of abbreviations or symbols should be avoided.<br />4- Self inspection 1- The system of quality assurance should include self-inspections. These should be conducted in order to monitor the implementation and compliance with the principles of GD &SP mentioned in this issue and to trigger necessary corrective and preventive measures. 2- Self-inspections should be conducted in an independent and detailed way by a designated, competent person. 3- All self-inspections should be recorded. Reports should contain all observations made during the inspection and, where applicable, proposals for corrective measures. Follow- up corrective actions taken should be documented and recshahzadhttp://www.blogger.com/profile/01364507074991292353noreply@blogger.comtag:blogger.com,1999:blog-7305327264533069235.post-2113159755702799142009-06-18T23:17:00.000-07:002009-06-18T23:18:34.132-07:00Storage area Organizing and handling of stored itemsA- Handling of material at storage area<br />1- Stored material should be isolated according to its specified storage conditions mentioned on the label and in line with the risks in case personnel could be subjected to on handling. Inflammable materials should be kept in suitable room, or in a fire resistant safe lock, dangerous substances should be clearly identified and labeled ,this also applies on radioactive , narcotic substances and any substances that can impose a hazard when used improperly.<br />2- Narcotic ,psychotropic drugs and radioactive substances should be stored in a manner that complies with international regulations and U.A.E laws( federal law number 4 for year 1983 ,federal law 14 for year 1995 for narcotics and federal law No 20 for products derived from natural resources ) and the relevant MOH instructions.<br />3- All procedures involving the dealing with and distribution of pharmaceuticals should comply with the GMP regulations issued by the drug control department in the year 2000.<br />4- Starting material and products should be isolated and be properly labeled in a way which prevents mix-up and cross contamination.<br />5- Stored materials and products should be stored ( kept within containers) that:<br /> Don’t affect the quality of products negatively.<br /> Provide the proper protection from the surrounding environmental factors as well microbial contamination.<br />6- A system should be in place to ensure that pharmaceutical products due to expire first are sold and/or distributed first (FEFO). Adequate controls should be in place to prevent the distribution of expired products.<br />7- Broken or damaged items should be withdrawn from usable stock, separated and labeled clearly.<br />8- Items that require refrigeration should be kept in fridges a way that prevents cross contamination, fridges’ temperature should be recorded periodically to ensure its consistency within the required limits. The location of the storing fridges should be properly chosen.<br />9- Storage conditions for products and materials should be in compliance with the labeling, which is based on the results of stability testing approved by Drug Control department on the product’s registration.<br /><br />B- Monitoring and control of storage conditions during storing and transportation<br />1- It is recommended that temperature monitors be located in areas that are most likely to show fluctuations according to a validated plan.<br />2- All recorded temperature and humidity monitoring data recorded out of continuous monitoring should be:<br /> Available for review.<br /> Comprise all the results of the regular checks made at suitable predetermined intervals recorded and retained from equipment designated for monitoring temperature degrees.<br /> Kept for at least the shelf-life of the stored material or product plus one year.<br /> Temperature mapping should show uniformity of the temperature across the storage facility or transporting vehicle.<br />C- Hygiene 1- Storage areas should be clean, and free from accumulated waste and vermin. A written validated sanitation program should be available indicating:<br /> Frequency of cleaning<br /> Methods to be used to clean the premises and storage areas.<br /> Written program for pest control. The pest-control agents used should be safe, and there should be no risk of contamination of the stored materials and products. There should be appropriate procedures.<br /> Written program for disinfection methods mentioning the periodic exchange of used disinfectants in a way prevents microbial resistance.<br /> Written program for maintaining used cleaning tools (utensils) clean.<br /> Procedures for the clean up of any spillage to ensure complete removal of any risk of contamination.<br />2- Training should be provided for cleaning personnel in a way that ensures their understanding of the importance of the cleaning procedures followed. 3- Washing station in the storing area should not be used for washing hands. 4- An instructions sign should be displayed stating the need for washing hands and the use of hot air and tissues for drying. 5- Toilets should not be used for storage purposes.shahzadhttp://www.blogger.com/profile/01364507074991292353noreply@blogger.comtag:blogger.com,1999:blog-7305327264533069235.post-11048137839229273902009-06-18T23:15:00.000-07:002009-06-18T23:17:16.328-07:00Premises, Instruments and vehiclesA- Premises:<br />1- Design and Layout of the storage site:<br />1-1 Storage areas should be designed or adapted to ensure the following good storage conditions:<br /> Proper cleanliness & Hygiene.<br /> Dry (relative humidity not more than 60%)<br /> Temperature should be within acceptable limits (8-25 degrees Celsius).<br /> Stored Goods and Materials should be stored off the floor<br /> Suitably spaced to permit cleaning and inspection.<br /> Pallets should be kept in a good state of cleanliness and repair.<br />1-2 Storing area should be sufficient to allow the storage of different items in orderly and separated avoiding jam packing. In this regards it is essential to designate separate areas for each of the following:<br /> Raw materials.<br /> Packaging material.<br /> Intermediate material.<br /> Finished product.<br /> Quarantined substances.<br /> Approved products.<br /> Rejected products.<br /> Recalled products.<br /> Returned products.<br /> Dangerous material.<br /> Inflammable substances.<br />1-3 Resting areas and areas for having food should be isolated from storing area. 1-4 Toilets and hand washing areas should be made available. 1-5 Toilets should not be opened directly into the storing area.<br />2- Specifications of the storage area<br />2-1 Precautionary physical arrangements and measurements should be taken in order to give access for those only authorized personnel to enter the storage area.<br />2-2 Storing area should have sufficient light to perform tasks in a correct, safe and accurate manner.<br /><br />2-3 In case of windows presence in the storage area, arrangements should be made to block Sunlight away from the stored items.<br />2-4 All surfaces, shelves, cupboards used should be covered with an impermeable and easy to clean smooth layer.<br />3- Receiving and dispatching area:<br /> Receiving and dispatch bays should protect products from the weather.<br /> Reception areas should be designed and equipped to allow containers of incoming pharmaceutical products to be cleaned, if necessary, before storage.<br />4- Quarantine area:<br />Quarantined material and Pharmaceutical products should be kept in specified quarantine areas until approved. This area should be:<br /> Well isolated, separated and clearly labeled.<br /> Restricted only for authorized personnel.<br /> Any system replacing physical quarantine should provide equivalent security, isolation and prevention of mixing up, provided that it is validated to demonstrate its effectiveness and security of access.<br />5- Sampling area:<br />There should be a designated area for sampling of primary material provided that it is:<br /> Isolated and of controlled and monitored environment.<br /> Sampling should be done in a certain manner to avoid contamination and cross contamination and according to a documented procedure.<br /> There should be a written cleaning procedure for cleaning of the sampling area effectively.<br />6- Rejected product area:<br />There should be a physical separation for defected products, rejected products, expired or recalled products so that it should be:<br /> Well controlled and prevent their use until a final decision is taken on their fate.<br /> It should be clearly labeled.<br /> Locked and restricted only to authorized personnel.<br /><br />B- Instruments:<br /> Equipment available in the storage area should only be used for its intended purpose only and to be used only in those licensed activities compliant with its license issued by Drug Control dept.<br /> All equipment should be calibrated and validated periodically including temperature monitoring devices, humidity monitoring devices and scales.<br />C-Vehicles:<br /> Vehicles and equipment used to distribute, store, or handle concerned materials and products should be properly designed and equipped to insure protection from different environmental and weather conditions that it is operating in. proper policies and written procedures should be in hand to insure the above objective.<br /> The design and use of vehicles and equipment must aim to minimize the risk of errors and permit effective cleaning and/or maintenance, in order to avoid contamination, build-up of dust or dirt and/or any adverse effect on the quality of pharmaceutical products being distributed. To make available clear and detailed written procedures and documenting records for the cleaning methods with specified frequency for each vehicle in use.<br /> The use of any vehicle other than of those designated should be avoided under any circumstance, and in case this has to happen there should be a written standard procedure for the vehicle’s cleaning instructions along with other instructions that specifies the acceptable type of items or materials that could be transported within the same vehicle. In this regard it is reminded that this choice is not recommended and should be kept only for unavoidable and limited cases.<br /> The use of vehicles with defects that could affect the quality of the product or transferred materials should be avoided. Defected vehicle if any should be fixed while being clearly labeled with its condition until defect removal is accomplished.<br /> Written standard procedures should be made available for operating and maintenance of transporting vehicles clarifying the frequency of each maintenance measure. Records signed by a qualified party contracted for maintenance should be made available and used to provide maintenance history evidence of the concerned vehicle.<br /> Special protective precautions should be followed for transporting products or materials which not provided with any protective packaging.<br /> Storage conditions (e.g. temperature and/or relative humidity) required for maintaining the quality of transported products or material ( as mentioned on their label) should be provided, checked, monitored and recorded. All monitoring records should be kept and made available for review at any time. Recorded<br /><br />monitoring data should be reviewed on receipt of pharmaceutical products to assess whether required storage conditions have been met.<br /> Vehicles and containers should be of sufficient capacity to allow orderly storage of the various categories of pharmaceutical products during transportation.<br /> Where possible mechanisms should be available to allow for the segregation during transit of rejected, recalled and returned pharmaceutical products as well as suspected to be counterfeits.<br /> Effective measures should be in place to prevent unauthorized persons from entering and/or tampering with vehicles and/or equipment, as well as to prevent the theft or misappropriation thereof.shahzadhttp://www.blogger.com/profile/01364507074991292353noreply@blogger.comtag:blogger.com,1999:blog-7305327264533069235.post-28707377657933717042009-06-18T23:13:00.000-07:002009-06-18T23:15:27.429-07:00Concerned establishments and ScopeA) Establishments concerned<br />Any pharmaceutical or health establishment which deals in handling, storing or distributing pharmaceutical or healthcare products has to be concerned by the guidelines and instructions mentioned in this issue. These establishments could be:<br /> Medical stores.<br /> Stores as part of pharmaceutical and medical devices manufacturing establishments.<br /> Nutrition & Health Dietary Supplements food stores.<br /> Herbal pharmaceutical stores.<br /> Private pharmacies and hospital pharmacies.<br /> Stores designated for storing pharmaceuticals and medical products at health establishments like hospitals and Public Healthcare institutions.<br />B) Management and Personnel:<br />1- There should be an adequate organizational structure defined with the aid of an organizational chart. The responsibility, authority and interrelationships of all personnel should be clearly defined and documented through clear job descriptions.<br />2- At each storage site (e.g. that of a manufacturer, distributor, wholesaler, and community or hospital pharmacy) there should be an adequate number of qualified personnel available at all working hours to achieve pharmaceutical quality assurance objectives.<br />3- A designated person should be appointed at each distribution point who should have defined authority and responsibility for ensuring that a quality management system is implemented and maintained. This person should be qualified according to the set requirements mentioned in the relevant administrative decision (circular).<br />4- All personnel (pharmacists and others) in the storage area should be provided by proper initial and continuous training related to the Good Distribution and Storage Practice, related rules and regulations, and safety regulations, in addition to be capable of meeting these requirements. The training records should be kept for review if needed.<br /><br />5- All members of staff should be trained in, and observe high levels of, personal hygiene and sanitation. Clear instructions for personal Hygiene should be distributed and observed.<br />6- Personnel employed in storage areas should wear suitable protective or working garments appropriate for the activities they perform.<br />7- First-aid procedures and equipment for dealing with emergencies involving personnel should be available.<br />8- There should be arrangements in place to ensure that management and personnel are not subject to commercial, financial and other pressures or conflicts of interest that may have an adverse effect on the quality of service provided.<br />9- Codes of practice and disciplinary procedures should be in place to prevent and address situations where persons involved in the distribution of pharmaceutical products are suspected of, or found to be implicated in, the misappropriation and/or theft thereof.<br />B- Contracting with third party:<br />1- Contracting (outsourcing) of certain storing or distribution services or activities is acceptable, given that these are outsourced from qualified and legitimate parties.<br />2- Any activity relating to the distribution of a pharmaceutical product which is delegated to another person or entity should be performed in terms of a written contract which is agreed upon by the contract giver and the contract accepter. The contract should define the responsibilities of each party including observance of the principles of GS &DP.shahzadhttp://www.blogger.com/profile/01364507074991292353noreply@blogger.comtag:blogger.com,1999:blog-7305327264533069235.post-33684910734831234182009-06-18T23:12:00.000-07:002009-06-18T23:13:47.916-07:00Definitions and technical termsDefinitions and technical terms<br /> Batch<br />A defined quantity of starting material, packaging material or product processed in a single process or series of processes so that it is expected to be homogeneous.<br /> Batch number<br />A distinctive combination of numbers and/or letters which uniquely identifies a batch on the labels, its batch records and corresponding certificates of analysis, etc.<br /> Consignment (or delivery)<br />The quantity of a pharmaceutical(s), made by one manufacturer and supplied at one time in response to a particular request or order. A consignment may comprise one or more packages or containers and may include material belonging to more than one batch.<br /> Container<br />The material employed in the packaging of a pharmaceutical product. Containers include primary, secondary and transportation containers. Containers are referred to as primary if they are intended to be in direct contact with the product. Secondary containers are not intended to be in direct contact with the product.<br /> Contamination<br />The undesired introduction of impurities of a chemical or microbiological nature, or of foreign matter, into or on to a starting material, intermediate or pharmaceutical product during handling, production, sampling, packaging or repackaging, storage or transport.<br /> Counterfeit<br />À counterfeit medicine is one which is deliberately and fraudulently mislabelled with respect to identity and/or source. Counterfeiting can apply to both branded and generic products and counterfeit products and may include products with the correct ingredients or with the wrong ingredients, without active ingredients, with insufficient active ingredients or with fake packaging.<br /> Cross-contamination<br />Contamination of a starting material, intermediate product or finished product, with another starting material or product during production.<br /> Distribution<br />The division and movement of pharmaceutical products from the premises of the manufacturer of such products, or another central point, to the end user thereof, or to an intermediate point by means of various transport methods, via various storage and/or health establishments.<br /><br /> Expiry date<br />The date given on the individual container (usually on the label) of a product up to and including which the product is expected to remain within specifications, if stored correctly. It is established for each batch by adding the shelf-life to the date of manufacture.<br /> Labeling<br />Process of identifying a product, by choosing and attaching the primary and secondary packaging (container) with the right label which includes all needed information regarding the product or material.<br /> Manufacture<br />All operations of purchase of materials and products, production, quality control, release, storage and distribution of pharmaceutical products, and the related controls.<br /> Material<br />A general term used to denote starting materials (active pharmaceutical ingredients and excipients), reagents, solvents, process aids, intermediates, packaging materials and labeling materials.<br /> Active pharmaceutical ingredient (API)<br />Any substance or mixture of substances intended to be used in the manufacture of a pharmaceutical dosage form and that, when used in the production of a drug, becomes an active ingredient of that drug. Such substances are intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment or prevention of disease, or to affect the structure and function of the body.<br /> Pharmaceutical product<br />Any medicine intended for human use or veterinary product administered to food producing animals, presented in its finished dosage form or as a starting material for use in such a dosage form, that is subject to control by pharmaceutical legislation in both the exporting state and the importing state.<br /> Product recall<br />Product recall is a process for withdrawing or removing a pharmaceutical product from the pharmaceutical distribution chain because of defects in the product or complaints of serious adverse reactions to the product. The recall might be initiated by the manufacturer/importer/ distributor or a responsible agency.<br /> Quality assurance<br />Quality assurance is a wide-ranging concept covering all matters that individually or collectively influence the quality of a product. It is the totality of the arrangements made<br /><br />with the object of ensuring that pharmaceutical products are of the quality required for their intended use.<br /> Quality control<br />Quality control covers all measures taken, including the setting of specifications, sampling, testing and analytical clearance, to ensure that starting materials, intermediates, packaging materials and finished pharmaceutical products conform with established specifications for identity, strength, purity and other characteristics.<br /> Quality system<br />An appropriate infrastructure, encompassing the organizational structure, procedures, processes and resources, and systematic actions necessary to ensure adequate confidence that a product (or services) will satisfy given requirements for quality.<br /> Quarantine<br />The status of starting or packaging materials, intermediates, or bulk or finished products isolated physically or by other effective means while a decision is awaited on their release, rejection or reprocessing.<br /> Shelf-life<br />The period of time during which a finished pharmaceutical product, if stored correctly, is expected to comply with the specification as determined by stability studies on a number of batches of the product. The shelf-life is used to establish the expiry date of each batch.<br /> Standard operating procedure (SOP)<br />An authorized, written procedure giving instructions for performing operations not necessarily specific to a given product but of a more general nature (e.g. equipment operation, maintenance and cleaning, validation, cleaning of premises and environmental control, sampling and inspection).<br /> Storage<br />The storing of pharmaceutical products up to the point of use.<br /> Validation<br />A documented program that provides a high degree of assurance that a specific process, method or system will consistently produce a result meeting pre-determined acceptance criteria.<br /> Vehicle<br />Vehicle refers to trucks, vans, buses, minibuses, cars, trailers, aircraft, railway carriages, boats and other means which are used to convey pharmaceutical products.<br /><br /> Supplier:<br />A person or party which provide the concerned establishment, pharmaceutical products and materials on request. Suppliers may be agents, brokers, distributors, manufacturers or traders. Suppliers should be authorized by a competent authority.<br /> Retest date:<br />The date when a material should be re-examined to ensure that it is still suitable for use.<br /> Normal Storage Conditions<br />Means to practice storage under environmental conditions described as dry with a good ventilation within temperature degrees range between 15 to 25 degrees Celsius that could extend to 30 degrees Celsius as marginal limit. The storage environment should be protected from any external vapors or smells, contamination factors and extensive direct light.<br /> Packaging material<br />Any material, including printed material, employed in the packaging of a pharmaceutical product, but excluding any outer packaging used for transportation or shipment. Packaging materials are referred to as primary or secondary according to whether or not they are intended to be in direct contact with the product.<br /> Specific Storage conditions:<br />Some pharmaceutical products require specific conditions to be stored within, and needs special instructions for storage handling and methods.<br /> Interpretation of instructions included on the product label:<br /> Not to exceed 30 Degree Celsius: means to store within the range from +2 to +30 Degrees Celsius.<br /> Not to exceed 25 Degree Celsius: means to store within the range from +2 to +25 Degrees Celsius<br /> Not to exceed 15 Degree Celsius: means to store within the range from +2 to +15 Degrees Celsius.<br /> Not to exceed 8 Degree Celsius: means to store within the range from +2 to +8 Degrees Celsius.<br /> Do not store below 8 Degree Celsius: means to store within the range from +8 to +25 Degrees Celsius.<br /> The product should be protected from humidity: means to protect it from conditions where humidity exceeds 60%, and should be kept in a humidity resistant container.<br /> Keep away from light: means that should be stored in places not exposed to light. It should be kept in light proof containers.shahzadhttp://www.blogger.com/profile/01364507074991292353noreply@blogger.comtag:blogger.com,1999:blog-7305327264533069235.post-77131397567931166622009-06-18T23:03:00.000-07:002009-06-18T23:04:11.989-07:00Good Storage Practices"<p align="center"><b><span style="font-family:Verdana;font-size:100%;"><br /> </span> <span style="font-family:Verdana;font-size:130%;color:#000099;"><br /> </span></b> </p> <p> <span style="font-family:Verdana;font-size:85%;"><br /> On the WHO homepage you can now find a topical document titled <b>Guide to Good Storage Practices for Pharmaceuticals</b>, which has been elaborated in close co-operation with the International Pharmaceutical Federation (FIP) and which will thus probably replace the quite old FIP Guideline on Good Storage Practices of 1980. </span> </p> <p><span style="font-family:Verdana;font-size:85%;">The new WHO document on GMP-compliant storage represents a complement to existing GMP regulations issued by WHO. These new <i> Good Storage Practices</i> are valid not only for manufacturers of medicinal products, but also for pharmaceutical importers, contractors and wholesalers.</span></p> <p><span style="font-family:Verdana;font-size:85%;">The focus topics are:</span></p> <ul><li><span style="font-family:Verdana;font-size:85%;">Personnel</span></li><li><span style="font-family:Verdana;font-size:85%;">Premises and facilities</span></li><li><span style="font-family:Verdana;font-size:85%;">Storage requirements</span></li><li><span style="font-family:Verdana;font-size:85%;">Returned goods</span></li><li><span style="font-family:Verdana;font-size:85%;">Dispatch and transport</span></li><li><span style="font-family:Verdana;font-size:85%;">Product recall</span></li></ul> <p><span style="font-family:Verdana;font-size:85%;">Compared to the former FIP Guideline, several new requirements have been added, some old ones, specified. Here some examples:</span></p> <ul><li><span style="font-family:Verdana;font-size:85%;">Precautions must be taken to prevent unauthorised persons from entering storage areas.</span></li><li><span style="font-family:Verdana;font-size:85%;">Materials and pharmaceutical products must not be stored directly on the floor.</span></li><li><span style="font-family:Verdana;font-size:85%;">There should be written programmes for many work routines (sanitation, pest control, measures in case of spillage, cleaning procedures for the sampling area, handling of returned goods, etc.).</span></li><li><span style="font-family:Verdana;font-size:85%;">Computerised systems used for storage administration (incl. quarantine and storage of rejected materials) have to be validated.</span></li><li><span style="font-family:Verdana;font-size:85%;">The traditional term <i>"First in – First out"</i> (FIFO) is now replaced correctly by the more specific <i>"first expired/first out"</i> (FEFO) principle.</span></li><li><span style="font-family:Verdana;font-size:85%;">In addition to the usual GMP requirements on the monitoring of storage conditions (temperature recording with calibrated equipment), temperature mapping should prove the uniformity of the temperature.</span></li><li><span style="font-family:Verdana;font-size:85%;">Returned goods may only be returned to saleable stock after the quality has been re-evaluated.<br /> In case patients have returned pharmaceuticals, these must not under any circumstances be returned to the saleable stock.</span></li><li><span style="font-family:Verdana;font-size:85%;">As for transport, especially the use of dry ice in cold chains is discussed (danger of damaging materials by freezing them accidentally) and the monitoring of transport conditions with the help of appropriate recording devices is recommended.</span></li></ul> <p><span style="font-family:Verdana;font-size:85%;">An appendix to the new WHO Guideline lists standardised storage and labelling conditions for drug products, which had already been fixed by WHO in this form in 1996.</span></p> <p><span style="font-family:Verdana;font-size:85%;">Unfortunately, this list does not contain any reference to the <i>Controlled Room Temperature </i>mentioned in the USP under "Stability" in the General Chapter <1151>. The controlled room temperature takes the mean kinetic temperature into account and allows thus for a certain flexibility regarding deviations from the prescribed storage temperature.</span></p> <p><span style="font-family:Verdana;font-size:85%;">By the way, this concept of mean kinetic temperature has also been mentioned in the European <i>CPMP Note for Guidance on Declaration of Storage Conditions for Medicinal Products in the Product Particulars and Active Substances</i> (CPMP/QWP/609/96/Rev.1).</span></p> <p><span style="font-family:Verdana;font-size:85%;">Therefore, it would also have been desirable to read this term in WHO's new <i>Good Storage Practices</i>. But the new Guide just says that temperature deviations may be tolerated only during short-term interruptions, e.g. during local transportation. </span></p> <p><span style="font-family:Verdana;font-size:85%;"><a href="http://www.who.int/medicines/library/qsm/good_storage.pdf"><br /></a></span></p> <p><span style="font-family:Verdana;font-size:85%;">Author:<br /> Dr Günter Brendelberger<br /> CONCEPT HEIDELBERG</span></p>shahzadhttp://www.blogger.com/profile/01364507074991292353noreply@blogger.comtag:blogger.com,1999:blog-7305327264533069235.post-55553874620587326822009-06-18T22:54:00.001-07:002009-06-22T22:25:06.214-07:00GOOD WAREHOUSING and DISTRIBUTION PRACTICES<p class="MsoNormal" style="TEXT-ALIGN: center" align="center"><b><span lang="EN-GB">Good Warehouse Practices<?xml:namespace prefix = o /><o:p></o:p></span></b></p><p class="MsoNormal"><span lang="EN-GB"><o:p></o:p></span></p><p class="MsoNormal" style="MARGIN-LEFT: 81pt"><span lang="EN-GB">1.<span style="font-size:+0;"> </span>Premises <o:p></o:p></span></p><p class="MsoNormal" style="MARGIN-LEFT: 81pt"><span lang="EN-GB">2.<span style="font-size:+0;"> </span>Security<o:p></o:p></span></p><p class="MsoNormal" style="MARGIN-LEFT: 81pt"><span lang="EN-GB">3.<span style="font-size:+0;"> </span>Temperature and humidity control <o:p></o:p></span></p><p class="MsoNormal" style="MARGIN-LEFT: 81pt"><span lang="EN-GB">4.<span style="font-size:+0;"> </span>Equipment <o:p></o:p></span></p><p class="MsoNormal" style="MARGIN-LEFT: 81pt"><span lang="EN-GB">5.<span style="font-size:+0;"> </span>Personnel<o:p></o:p></span></p><p class="MsoNormal" style="MARGIN-LEFT: 81pt"><span lang="EN-GB">6.<span style="font-size:+0;"> </span>Sanitation <o:p></o:p></span></p><p class="MsoNormal" style="MARGIN-LEFT: 81pt"><span lang="EN-GB">7.<span style="font-size:+0;"> </span>Receipt of incoming goods<o:p></o:p></span></p><p class="MsoNormal" style="MARGIN-LEFT: 81pt"><span lang="EN-GB">8.<span style="font-size:+0;"> </span>Assembling orders and issuing goods<o:p></o:p></span></p><p class="MsoNormal" style="MARGIN-LEFT: 81pt"><span lang="EN-GB">9.<span style="font-size:+0;"> </span>Packing for transportation<o:p></o:p></span></p><p class="MsoNormal" style="MARGIN-LEFT: 81pt"><span lang="EN-GB">10. Transport<o:p></o:p></span></p><p class="MsoNormal"><span lang="EN-GB"><o:p></o:p></span></p><p class="MsoNormal"><b><u><br /><o:p></o:p></u></b></p><p class="MsoNormal" style="TEXT-ALIGN: center" align="center"><b><span lang="EN-GB">Premises<o:p></o:p></span></b></p><p class="MsoNormal" style="TEXT-ALIGN: center" align="center"><span lang="EN-GB"><o:p></o:p></span></p><p class="MsoNormal" style="MARGIN-LEFT: 0.5in; TEXT-INDENT: -0.5in"><span lang="EN-GB">Premises should be of suitable size and construction to facilitate cleaning, maintenance and orderly, segregated storage <span style="font-size:+0;"></span><o:p></o:p></span></p><p class="MsoNormal" style="MARGIN-LEFT: 0.5in; TEXT-INDENT: -0.5in"><span lang="EN-GB">Storage areas must be designed to provide adequate:<o:p></o:p></span></p><p class="MsoNormal" style="MARGIN-LEFT: 81pt"><span lang="EN-GB"><span style="font-size:+0;"></span>- lightening,<o:p></o:p></span></p><p class="MsoNormal" style="MARGIN-LEFT: 81pt"><span lang="EN-GB"><span style="font-size:+0;"></span>- ventilation,<o:p></o:p></span></p><p class="MsoNormal" style="MARGIN-LEFT: 81pt"><span lang="EN-GB"><span style="font-size:+0;"></span>- temperature,<o:p></o:p></span></p><p class="MsoNormal" style="MARGIN-LEFT: 81pt"><span lang="EN-GB"><span style="font-size:+0;"></span>- sanitation,<o:p></o:p></span></p><p class="MsoNormal" style="MARGIN-LEFT: 81pt"><span lang="EN-GB"><span style="font-size:+0;"></span>- humidity,<o:p></o:p></span></p><p class="MsoNormal" style="MARGIN-LEFT: 81pt"><span lang="EN-GB"><span style="font-size:+0;"></span>- space, <o:p></o:p></span></p><p class="MsoNormal" style="MARGIN-LEFT: 81pt"><span lang="EN-GB"><span style="font-size:+0;"></span>- equipment,<o:p></o:p></span></p><p class="MsoNormal" style="MARGIN-LEFT: 81pt"><span lang="EN-GB"><span style="font-size:+0;"></span>- security conditions<o:p></o:p></span></p><p class="MsoNormal"><span lang="EN-GB"><o:p></o:p></span></p><p class="MsoNormal"><b><u><br /><o:p></o:p></u></b></p><p class="MsoNormal"><b><u><o:p><span style="TEXT-DECORATION: none"></span></o:p></u></b></p><p class="MsoNormal" style="MARGIN-LEFT: 0.5in; TEXT-INDENT: -0.5in; TEXT-ALIGN: justify"><span lang="EN-GB" style="font-family:Wingdings;"><span style="font-size:+0;"><span style="font-family:';font-size:7;"> </span></span></span><span lang="EN-GB">Medicinal products should be stored separate from other goods to avoid the risk of cross contamination<o:p></o:p></span></p><p class="MsoNormal" style="MARGIN-LEFT: 0.5in; TEXT-INDENT: -0.5in; TEXT-ALIGN: justify"><span lang="EN-GB"><span style="font-size:+0;"> </span>Incoming goods should be physically or electronically separated from goods awaiting distribution until approved by the responsible person<o:p></o:p></span></p><p class="MsoNormal" style="MARGIN-LEFT: 0.5in; TEXT-INDENT: -0.5in; TEXT-ALIGN: justify"><span lang="EN-GB"><span style="font-size:+0;"> </span>A segregated area must be provided for the holding and storage of <u>returned and rejected </u><span style="font-size:+0;"></span>goods prior to a decision on further action<o:p></o:p></span></p><p class="MsoNormal" style="MARGIN-LEFT: 0.5in; TEXT-INDENT: -0.5in; TEXT-ALIGN: justify"><span lang="EN-GB"> A secure, segregated area must be provided for the storage of controlled drugs<o:p></o:p></span></p><p class="MsoNormal" style="MARGIN-LEFT: 0.5in; TEXT-INDENT: -0.5in; TEXT-ALIGN: justify"><span lang="EN-GB"><span style="font-size:+0;"> </span>A separate, designed area should be provided for the assembly of customer orders<o:p></o:p></span></p><p class="MsoNormal"><b><u><o:p><span style="TEXT-DECORATION: none"></span></o:p></u></b></p><p class="MsoNormal"><b><u><o:p><span style="TEXT-DECORATION: none"></span></o:p></u></b></p><p class="MsoNormal"><b><u><br /><o:p></o:p></u></b></p><p class="MsoNormal" style="TEXT-ALIGN: center" align="center"><b><span lang="EN-GB">Security<o:p></o:p></span></b></p><p class="MsoNormal"><span lang="EN-GB"><o:p></o:p></span></p><p class="MsoNormal" style="MARGIN-LEFT: 0.5in; TEXT-INDENT: -0.5in; TEXT-ALIGN: justify"><span lang="EN-GB"> Storage areas should be provided with security to prevent theft or unauthorised entry<span style="font-size:+0;"> </span><o:p></o:p></span></p><p class="MsoNormal" style="MARGIN-LEFT: 0.5in; TEXT-INDENT: -0.5in; TEXT-ALIGN: justify"><span lang="EN-GB"> Maintain a control of who may enter the facilities <o:p></o:p></span></p><p class="MsoNormal" style="MARGIN-LEFT: 0.5in; TEXT-INDENT: -0.5in; TEXT-ALIGN: justify"><!--[if !supportLists]--><span lang="EN-GB" style="font-family:Wingdings;"><span style="font-size:+0;">u<span style="font-family:';font-size:7;"> </span></span></span><!--[endif]--><span lang="EN-GB"><span style="font-size:+0;"> </span>Establish system for controlling access to the facility (including all entrances and exits)<o:p></o:p></span></p><p class="MsoNormal"><span lang="EN-GB"><o:p></o:p></span></p><br /><p class="MsoNormal"><b><u><br /><o:p></o:p></u></b></p><p class="MsoNormal" style="TEXT-ALIGN: center" align="center"><b><span lang="EN-GB">Temperature and Humidity Control<o:p></o:p></span></b></p><p class="MsoNormal"><span lang="EN-GB"><o:p></o:p></span></p><p class="MsoNormal" style="MARGIN-LEFT: 0.5in; TEXT-INDENT: -0.5in; TEXT-ALIGN: justify"><!--[if !supportLists]--><span lang="EN-GB" style="font-family:Wingdings;"><span style="font-size:+0;">u<span style="font-family:';font-size:7;"> </span></span></span><!--[endif]--><span lang="EN-GB">All drug products must be stored at appropriate conditions as stated on the label of the product<o:p></o:p></span></p><p class="MsoNormal" style="MARGIN-LEFT: 0.5in; TEXT-INDENT: -0.5in; TEXT-ALIGN: justify"><!--[if !supportLists]--><span lang="EN-GB" style="font-family:Wingdings;"><span style="font-size:+0;">u<span style="font-family:';font-size:7;"> </span></span></span><!--[endif]--><span lang="EN-GB">The temperature of all storage areas should be regularly monitored.<o:p></o:p></span></p><p class="MsoNormal" style="MARGIN-LEFT: 0.5in; TEXT-INDENT: -0.5in; TEXT-ALIGN: justify"><!--[if !supportLists]--><span lang="EN-GB" style="font-family:Wingdings;"><span style="font-size:+0;">u<span style="font-family:';font-size:7;"> </span></span></span><!--[endif]--><span lang="EN-GB">Controlled temperature storage areas should be equipped with recorders and devices which indicate when the specific temperature range has not been maintained.<o:p></o:p></span></p><p class="MsoNormal" style="MARGIN-LEFT: 0.5in; TEXT-INDENT: -0.5in; TEXT-ALIGN: justify"><!--[if !supportLists]--><span lang="EN-GB" style="font-family:Wingdings;"><span style="font-size:+0;">u<span style="font-family:';font-size:7;"> </span></span></span><!--[endif]--><span lang="EN-GB"><span style="font-size:+0;"> </span>A written procedure must specify the action to be taken when this occurs Control should be adequate to ensure that all parts of the storage area are kept within the specified temperature range<o:p></o:p></span></p><p class="MsoNormal" style="MARGIN-LEFT: 0.5in; TEXT-INDENT: -0.5in; TEXT-ALIGN: justify"><!--[if !supportLists]--><span lang="EN-GB" style="font-family:Wingdings;"><span style="font-size:+0;">u<span style="font-family:';font-size:7;"> </span></span></span><!--[endif]--><span lang="EN-GB"><span style="font-size:+0;"> </span>Should always be a back up system in case main system fails<o:p></o:p></span></p><p class="MsoNormal" style="TEXT-ALIGN: justify"><span lang="EN-GB"><o:p></o:p></span></p><p class="MsoNormal"><span lang="EN-GB"><o:p></o:p></span></p><p class="MsoNormal"><b><u><br /><o:p></o:p></u></b></p><p class="MsoNormal"><span lang="EN-GB"><o:p></o:p></span></p><p class="MsoNormal" style="MARGIN-LEFT: 0.5in; TEXT-INDENT: -0.5in; TEXT-ALIGN: justify"><!--[if !supportLists]--><span lang="EN-GB" style="font-family:Wingdings;"><span style="font-size:+0;">u<span style="font-family:';font-size:7;"> </span></span></span><!--[endif]--><span lang="EN-GB">The humidity of all storage areas should be regularly monitored using recorders and devices which document the humidity measures<o:p></o:p></span></p><p class="MsoNormal" style="MARGIN-LEFT: 0.5in; TEXT-INDENT: -0.5in; TEXT-ALIGN: justify"><!--[if !supportLists]--><span lang="EN-GB" style="font-family:Wingdings;"><span style="font-size:+0;">u<span style="font-family:';font-size:7;"> </span></span></span><!--[endif]--><span lang="EN-GB"><span style="font-size:+0;"> </span>If the product spec require a specific humidity, a written procedure must specify the action to be taken when the specified humidity range has not been maintained. <span style="font-size:+0;"></span><o:p></o:p></span></p><p class="MsoNormal" style="MARGIN-LEFT: 0.5in; TEXT-INDENT: -0.5in; TEXT-ALIGN: justify"><!--[if !supportLists]--><span lang="EN-GB" style="font-family:Wingdings;"><span style="font-size:+0;">u<span style="font-family:';font-size:7;"> </span></span></span><!--[endif]--><span lang="EN-GB"><span style="font-size:+0;"> </span>Establish a normal operating baseline of humidity if no specific value is required <span style="font-size:+0;"></span><o:p></o:p></span></p><p class="MsoNormal" style="MARGIN-LEFT: 0.5in; TEXT-INDENT: -0.5in; TEXT-ALIGN: justify"><span lang="EN-GB"><span style="font-size:+0;"> </span>Records of temperature and humidity in all storage areas should be reviewed and retained by a designated responsible person<o:p></o:p></span></p><p class="MsoNormal" style="TEXT-INDENT: -0.5in"><span lang="EN-GB"><o:p></o:p></span></p><p class="MsoNormal" style="TEXT-INDENT: -0.5in"><span lang="EN-GB"><o:p></o:p></span></p><p class="MsoNormal"><b><u><br /><o:p></o:p></u></b></p><p class="MsoNormal" style="TEXT-ALIGN: center" align="center"><b>Equipments<o:p></o:p></b></p><p class="MsoNormal"><u><o:p><span style="TEXT-DECORATION: none"></span></o:p></u></p><p class="MsoNormal" style="MARGIN-LEFT: 0.5in; TEXT-INDENT: -0.5in; TEXT-ALIGN: justify"><span lang="EN-GB"> There should be a planned preventative maintenance programme in place <o:p></o:p></span></p><p class="MsoNormal" style="MARGIN-LEFT: 0.5in; TEXT-INDENT: -0.5in; TEXT-ALIGN: justify"> <span lang="EN-GB">, recording and control equipment should be<span style="font-size:+0;"> </span>calibrated and checked at defined intervals by appropriate methods <o:p></o:p></span></p><p class="MsoNormal" style="MARGIN-LEFT: 0.5in; TEXT-INDENT: -0.5in; TEXT-ALIGN: justify"><span lang="EN-GB"><span style="font-size:+0;"> </span>Alarm set-points should be checked on periodic intervals </span></p><p class="MsoNormal" style="MARGIN-LEFT: 0.5in; TEXT-INDENT: -0.5in; TEXT-ALIGN: justify"> <span lang="EN-GB"><span style="font-size:+0;"> </span>A computerised system used for stock control/distribution<span style="font-size:+0;"> </span>should be validated <o:p></o:p></span></p><p class="MsoNormal"><o:p></o:p><b><u><o:p></o:p></u></b></p><p class="MsoNormal" style="TEXT-ALIGN: center" align="center"><b><span lang="EN-GB">Person</span></b></p><p class="MsoNormal" style="TEXT-ALIGN: center" align="center"><span lang="EN-GB">The organisation chart should be in place<o:p></o:p></span></p><p class="MsoNormal" style="MARGIN-LEFT: 0.5in; TEXT-INDENT: -0.5in; TEXT-ALIGN: justify"><span lang="EN-GB"> There should be a sufficient number of staff<o:p></o:p></span></p><p class="MsoNormal" style="MARGIN-LEFT: 0.5in; TEXT-INDENT: -0.5in; TEXT-ALIGN: justify"><span lang="EN-GB"> There should be clearly defined job description<span style="font-size:+0;"> </span><o:p></o:p></span></p><p class="MsoNormal" style="MARGIN-LEFT: 0.5in; TEXT-INDENT: -0.5in; TEXT-ALIGN: justify"><span lang="EN-GB"> Personnel should be trained in relation to good storage and distribution practice and to <span style="font-size:+0;"></span><o:p></o:p></span></p><p class="MsoNormal" style="TEXT-ALIGN: justify"><span lang="EN-GB"><span style="font-size:+0;"></span> the duties assigned to them<o:p></o:p></span></p><p class="MsoNormal" style="MARGIN-LEFT: 0.5in; TEXT-INDENT: -0.5in; TEXT-ALIGN: justify"><span lang="EN-GB"> The current records of training should be in place<o:p></o:p></span></p><p class="MsoNormal" style="MARGIN-LEFT: 0.5in; TEXT-INDENT: -0.5in; TEXT-ALIGN: justify"><span lang="EN-GB"> The trainers should have established and approved qualification<o:p></o:p></span></p><p class="MsoNormal"><b><u><br /><o:p></o:p></u></b></p><p class="MsoNormal" style="TEXT-ALIGN: center" align="center"><b><span lang="EN-GB">Sanitation<o:p></o:p></span></b></p><p class="MsoNormal"><span lang="EN-GB"><o:p></o:p></span></p><p class="MsoNormal" style="MARGIN-LEFT: 0.5in; TEXT-INDENT: -0.5in; TEXT-ALIGN: justify"><span lang="EN-GB">A written sanitation program should be in place indicating<span style="font-size:+0;"> </span>the frequency and method of cleaning the facility<o:p></o:p></span></p><p class="MsoNormal" style="MARGIN-LEFT: 0.5in; TEXT-INDENT: -0.5in; TEXT-ALIGN: justify"><span lang="EN-GB">Storage areas should be cleaned and accumulated waste<span style="font-size:+0;"> </span>removed at regular intervals<o:p></o:p></span></p><p class="MsoNormal" style="MARGIN-LEFT: 0.5in; TEXT-INDENT: -0.5in; TEXT-ALIGN: justify"><span lang="EN-GB"><span style="font-size:+0;"> </span>A pest control program should be in place<o:p></o:p></span></p><p class="MsoNormal" style="MARGIN-LEFT: 0.5in; TEXT-INDENT: -0.5in; TEXT-ALIGN: justify"><span lang="EN-GB"><span style="font-size:+0;"> </span>Smoking, eating and drinking should be permitted only in segregated areas, and not in those areas used for the storage <span style="font-size:+0;"></span>and handling of final drug product<o:p></o:p></span></p><p class="MsoNormal" style="MARGIN-LEFT: 0.5in; TEXT-INDENT: -0.5in; TEXT-ALIGN: justify"><span lang="EN-GB"><span style="font-size:+0;"> </span>Spills involving drug products must be promptly cleaned-up and rendered safe in accordance with the relevant health <span style="font-size:+0;"></span>and safety requirements for the product<o:p></o:p></span></p><p class="MsoNormal" style="MARGIN-LEFT: 0.5in; TEXT-INDENT: -0.5in; TEXT-ALIGN: justify"><span lang="EN-GB">Adequate toilet and changing facilities should be provided, and they should be segregated from the main storage and <span style="font-size:+0;"></span>order assembly areas<o:p></o:p></span></p><p class="MsoNormal"><span lang="EN-GB"><o:p></o:p></span></p><p class="MsoNormal"><span lang="EN-GB"><o:p></o:p></span><b><u><o:p></o:p></u></b></p><p class="MsoNormal" style="TEXT-ALIGN: center" align="center"><b><span lang="EN-GB">Receipt of incoming goods<o:p></o:p></span></b></p><p class="MsoNormal"><span lang="EN-GB"><o:p></o:p></span></p><p class="MsoNormal" style="TEXT-ALIGN: justify"><i><span lang="EN-GB">It should be carried out according to approved adequate SOP:<o:p></o:p></span></i></p><p class="MsoNormal" style="TEXT-ALIGN: justify"><span lang="EN-GB"><o:p></o:p></span></p><p class="MsoNormal" style="MARGIN-LEFT: 0.5in; TEXT-INDENT: -0.5in; TEXT-ALIGN: justify"><span lang="EN-GB">visually examine for identity against the relevant supplier’s <span style="font-size:+0;"></span>documentation<o:p></o:p></span></p><p class="MsoNormal" style="MARGIN-LEFT: 0.5in; TEXT-INDENT: -0.5in; TEXT-ALIGN: justify"><span lang="EN-GB">visually examine for damage<o:p></o:p></span></p><p class="MsoNormal" style="MARGIN-LEFT: 0.5in; TEXT-INDENT: -0.5in; TEXT-ALIGN: justify"><span lang="EN-GB">sub-divide according to batch numbers if more than one batch<o:p></o:p></span></p><p class="MsoNormal" style="MARGIN-LEFT: 0.5in; TEXT-INDENT: -0.5in; TEXT-ALIGN: justify"><span lang="EN-GB">reject product if damage or otherwise unfit for use<o:p></o:p></span></p><p class="MsoNormal" style="MARGIN-LEFT: 0.5in; TEXT-INDENT: -0.5in; TEXT-ALIGN: justify"><span lang="EN-GB">handle high security materials (control drug, high value items, products requiring a specific storage temperature)<o:p></o:p></span></p><p class="MsoNormal" style="MARGIN-LEFT: 0.5in; TEXT-INDENT: -0.5in; TEXT-ALIGN: justify"><span lang="EN-GB">confirm with signature that receiving goods are as specified by supplier or if not provide adequate comments<o:p></o:p></span></p><p class="MsoNormal"><span lang="EN-GB"><o:p></o:p></span></p><p class="MsoNormal"><b><u><br /><o:p></o:p></u></b></p><p class="MsoNormal" style="TEXT-ALIGN: center" align="center"><b><span lang="EN-GB">Assembling orders and issuing goods</span></b><o:p></o:p></p><p class="MsoNormal"><span lang="EN-GB"><o:p></o:p></span></p><p class="MsoNormal" style="TEXT-ALIGN: justify"><i><span lang="EN-GB">It should be carried out according to approved adequate SOP:<o:p></o:p></span></i></p><p class="MsoNormal" style="TEXT-ALIGN: justify"><span lang="EN-GB"><o:p></o:p></span></p><p class="MsoNormal" style="MARGIN-LEFT: 0.5in; TEXT-INDENT: -0.5in; TEXT-ALIGN: justify"><span lang="EN-GB" style="font-family:Wingdings;"><span style="font-size:+0;"><span style="font-family:';font-size:7;"> </span></span></span><span lang="EN-GB">Pick up goods according to formal despatch documents<o:p></o:p></span></p><p class="MsoNormal" style="MARGIN-LEFT: 0.5in; TEXT-INDENT: -0.5in; TEXT-ALIGN: justify"><span lang="EN-GB"> Assemble complete order<o:p></o:p></span></p><p class="MsoNormal" style="MARGIN-LEFT: 0.5in; TEXT-INDENT: -0.5in; TEXT-ALIGN: justify">><span lang="EN-GB">Visually examine for identity and completeness<o:p></o:p></span></p><p class="MsoNormal" style="MARGIN-LEFT: 0.5in; TEXT-INDENT: -0.5in; TEXT-ALIGN: justify"><span lang="EN-GB">Visually examine for damage <o:p></o:p></span></p><p class="MsoNormal" style="MARGIN-LEFT: 0.5in; TEXT-INDENT: -0.5in; TEXT-ALIGN: justify"><span lang="EN-GB">Confirm with signature properly assembled order<o:p></o:p></span></p><p class="MsoNormal" style="MARGIN-LEFT: 0.5in; TEXT-INDENT: -0.5in; TEXT-ALIGN: justify"><span lang="EN-GB">Prepare adequate shipping package to protect any damage<span style="font-size:+0;"> </span>of goods, seal pack and provide relevant identification<o:p></o:p></span></p><p class="MsoNormal" style="MARGIN-LEFT: 0.5in; TEXT-INDENT: -0.5in; TEXT-ALIGN: justify"><span lang="EN-GB">The heat sensitive drugs if not transported by appropriate <span style="font-size:+0;"></span>specialised means should be provided isolated packing<o:p></o:p></span></p><p class="MsoNormal"><span lang="EN-GB"><o:p></o:p></span></p><p class="MsoNormal"><span lang="EN-GB"><o:p></o:p></span></p><p class="MsoNormal"><span lang="EN-GB"><o:p></o:p></span></p><p class="MsoNormal"><span lang="EN-GB"><o:p></o:p></span></p><p class="MsoNormal"><span lang="EN-GB"><o:p></o:p></span></p><p class="MsoNormal"><span lang="EN-GB"><o:p></o:p></span></p><p class="MsoNormal"><span lang="EN-GB"><o:p></o:p></span></p><p class="MsoNormal"><span lang="EN-GB"><o:p></o:p></span></p><p class="MsoNormal"><span lang="EN-GB"><o:p></o:p></span></p><p class="MsoNormal"><span lang="EN-GB"><o:p></o:p></span><b><u><o:p></o:p></u></b></p><p class="MsoNormal" style="TEXT-ALIGN: center" align="center"><b><span lang="EN-GB">Packing for transportation</span><o:p></o:p></b></p><p class="MsoNormal"><b><span lang="EN-GB"><o:p></o:p></span></b></p><p class="MsoNormal" style="TEXT-ALIGN: justify"><span lang="EN-GB">Products should be packed in such a way that:<o:p></o:p></span></p><p class="MsoNormal" style="MARGIN-LEFT: 0.5in; TEXT-INDENT: -0.25in; TEXT-ALIGN: justify"><span lang="EN-GB"><span style="font-size:+0;"> </span>the identification of the product is not lost,<o:p></o:p></span></p><p class="MsoNormal" style="MARGIN-LEFT: 0.5in; TEXT-INDENT: -0.25in; TEXT-ALIGN: justify"><span lang="EN-GB">the product does not contaminate and is not contaminated by other products or materials<o:p></o:p></span></p><p class="MsoNormal" style="MARGIN-LEFT: 0.5in; TEXT-INDENT: -0.25in; TEXT-ALIGN: justify"><span lang="EN-GB"><span style="font-size:+0;"> </span>adequate precautions are taken against spillage and breakage<o:p></o:p></span></p><p class="MsoNormal" style="MARGIN-LEFT: 0.5in; TEXT-INDENT: -0.25in; TEXT-ALIGN: justify"><span lang="EN-GB">products requiring controlled temperature storage should be provided with insulated packs <o:p></o:p></span></p><p class="MsoNormal" style="MARGIN-LEFT: 0.5in; TEXT-INDENT: -0.25in; TEXT-ALIGN: justify"><span lang="EN-GB"><span style="font-size:+0;"> </span>there should be in place documented evidence that the insulated packs ensured adequate transport conditions with regards to:<o:p></o:p></span></p><p class="MsoNormal" style="MARGIN-LEFT: 81pt; TEXT-ALIGN: justify"><span lang="EN-GB"><span style="font-size:+0;"></span>- product quantity<o:p></o:p></span></p><p class="MsoNormal" style="MARGIN-LEFT: 81pt; TEXT-ALIGN: justify"><span lang="EN-GB"><span style="font-size:+0;"></span>- ambient temperature<o:p></o:p></span></p><p class="MsoNormal" style="MARGIN-LEFT: 81pt; TEXT-ALIGN: justify"><span lang="EN-GB"><span style="font-size:+0;"></span>- maximum delivery time. <o:p></o:p></span></p><p class="MsoNormal"><span lang="EN-GB"><o:p></o:p></span></p><p class="MsoNormal"><b><u><br /><o:p></o:p></u></b></p><p class="MsoNormal" style="TEXT-ALIGN: center" align="center"><b><span lang="EN-GB">Transport</span></b><o:p></o:p></p><p class="MsoNormal"><span lang="EN-GB"><o:p></o:p></span></p><p class="MsoNormal" style="TEXT-ALIGN: justify"><span lang="EN-GB">Products should be transported in such a way that:<o:p></o:p></span></p><p class="MsoNormal" style="TEXT-ALIGN: justify"><span lang="EN-GB"><o:p></o:p></span></p><p class="MsoNormal" style="MARGIN-LEFT: 0.5in; TEXT-INDENT: -0.25in; TEXT-ALIGN: justify"><span lang="EN-GB"><span style="font-size:+0;"> </span>The safety, identity, strength, quality and purity of the product is not lost<o:p></o:p></span></p><p class="MsoNormal" style="MARGIN-LEFT: 0.5in; TEXT-INDENT: -0.25in; TEXT-ALIGN: justify"><span lang="EN-GB">The product is not contaminated by other products or<span style="font-size:+0;"> </span>materials<o:p></o:p></span></p><p class="MsoNormal" style="MARGIN-LEFT: 0.5in; TEXT-INDENT: -0.25in; TEXT-ALIGN: justify"><span lang="EN-GB"><span style="font-size:+0;"> </span>Adequate precautions are taken against spillage or breakage<o:p></o:p></span></p><p class="MsoNormal" style="MARGIN-LEFT: 0.5in; TEXT-INDENT: -0.25in; TEXT-ALIGN: justify"><span lang="EN-GB"><span style="font-size:+0;"> </span>The product and its package are not subjected to unacceptable degrees of heat, cold, light, moisture or other adverse influences nor to attack by micro-organisms or pests <o:p></o:p></span></p><p class="MsoNormal" style="MARGIN-LEFT: 0.5in; TEXT-INDENT: -0.25in; TEXT-ALIGN: justify"><span lang="EN-GB"><span style="font-size:+0;"> </span>Drug products requiring controlled temperature storage by appropriate specialised means or should be packed with adequate</span><span lang="EN-GB"> </span><span lang="EN-GB">insulation<o:p></o:p></span></p><p class="MsoNormal"><span lang="EN-GB"><o:p></o:p></span></p><p class="MsoNormal"><span lang="EN-GB"><o:p></o:p></span><b><u><o:p></o:p></u></b></p><p class="MsoNormal" style="TEXT-ALIGN: center" align="center"><b><span lang="EN-GB">Transport</span></b><o:p></o:p></p><p class="MsoNormal"><span lang="EN-GB"><o:p></o:p></span></p><p class="MsoNormal" style="TEXT-ALIGN: justify"><span lang="EN-GB">Documents should be provided to cover all shipments. These document should include as minimum:<o:p></o:p></span></p><p class="MsoNormal" style="TEXT-ALIGN: justify"><span lang="EN-GB"><o:p></o:p></span></p><p class="MsoNormal" style="MARGIN-LEFT: 0.5in; TEXT-INDENT: -0.25in; TEXT-ALIGN: justify"><span lang="EN-GB"><span style="font-size:+0;"> </span>name of the product<o:p></o:p></span></p><p class="MsoNormal" style="MARGIN-LEFT: 0.5in; TEXT-INDENT: -0.25in; TEXT-ALIGN: justify"><span lang="EN-GB"><span style="font-size:+0;"> </span>quantity of the product<o:p></o:p></span></p><p class="MsoNormal" style="MARGIN-LEFT: 0.5in; TEXT-INDENT: -0.25in; TEXT-ALIGN: justify"><span lang="EN-GB">special storage and handling instructions<o:p></o:p></span></p><p class="MsoNormal" style="TEXT-ALIGN: justify"><span lang="EN-GB"><o:p></o:p></span></p><p class="MsoNormal"><b><u><o:p><span style="TEXT-DECORATION: none"></span></o:p></u></b></p><p class="MsoNormal"><b><u><o:p><span style="TEXT-DECORATION: none"></span></o:p></u></b></p><br /><p class="MsoNormal"><b><u><br /><o:p></o:p></u></b></p><p class="MsoNormal" style="TEXT-ALIGN: center" align="center"><b><span lang="EN-GB">Records</span></b><o:p></o:p></p><p class="MsoNormal"><span lang="EN-GB"><o:p></o:p></span></p><p class="MsoNormal"><span lang="EN-GB">Following records should be in place:<o:p></o:p></span></p><p class="MsoNormal" style="MARGIN-LEFT: 1in; TEXT-INDENT: -0.25in"><span lang="EN-GB">receiving goods<o:p></o:p></span></p><p class="MsoNormal" style="MARGIN-LEFT: 1in; TEXT-INDENT: -0.25in"><span lang="EN-GB"><span style="font-size:+0;"> </span>issuing goods<o:p></o:p></span></p><p class="MsoNormal" style="MARGIN-LEFT: 1in; TEXT-INDENT: -0.25in"><span lang="EN-GB">training<o:p></o:p></span></p><p class="MsoNormal" style="MARGIN-LEFT: 1in; TEXT-INDENT: -0.25in"><span lang="EN-GB"><span style="font-size:+0;"> </span>monitoring temperature and humidity<o:p></o:p></span></p><p class="MsoNormal" style="MARGIN-LEFT: 1in; TEXT-INDENT: -0.25in"><span lang="EN-GB"><span style="font-size:+0;"> </span>cleaning operation<o:p></o:p></span></p><p class="MsoNormal" style="MARGIN-LEFT: 1in; TEXT-INDENT: -0.25in"><span lang="EN-GB"><span style="font-size:+0;"> </span>pest control <o:p></o:p></span></p><p class="MsoNormal" style="MARGIN-LEFT: 1in; TEXT-INDENT: -0.25in"><span lang="EN-GB"><span style="font-size:+0;"> </span>calibration <o:p></o:p></span></p><p class="MsoNormal" style="MARGIN-LEFT: 1in; TEXT-INDENT: -0.25in"><span lang="EN-GB"><span style="font-size:+0;"> </span>preventative maintenance<o:p></o:p></span></p><p class="MsoNormal" style="MARGIN-LEFT: 1in; TEXT-INDENT: -0.25in"><span lang="EN-GB">recall<o:p></o:p></span></p><p class="MsoNormal" style="MARGIN-LEFT: 1in; TEXT-INDENT: -0.25in"><span lang="EN-GB"><span style="font-size:+0;"> </span>complaints<o:p></o:p></span></p><p class="MsoNormal" style="MARGIN-LEFT: 1in; TEXT-INDENT: -0.25in"><span lang="EN-GB">inventory<o:p></o:p></span></p><p class="MsoNormal" style="MARGIN-LEFT: 1in; TEXT-INDENT: -0.25in"><span lang="EN-GB">log of signature<o:p></o:p></span></p><p class="MsoNormal"><span lang="EN-GB"><o:p></o:p></span></p><p class="MsoNormal"><span lang="EN-GB"><o:p></o:p></span><b><u><br /><o:p></o:p></u></b></p><p class="MsoNormal" style="TEXT-ALIGN: center" align="center"><b><span lang="PL">Good Distribution Practices</span></b><o:p></o:p></p><p class="MsoNormal"><span lang="EN-GB"><o:p></o:p></span></p><p class="MsoNormal" style="MARGIN-LEFT: 81pt; TEXT-INDENT: -27pt"><span style="font-size:+0;">1. Personnel<o:p></o:p></span></p><p class="MsoNormal" style="MARGIN-LEFT: 81pt; TEXT-INDENT: -27pt"><span style="font-size:+0;">2. Documentation and Records<o:p></o:p></span></p><p class="MsoNormal" style="MARGIN-LEFT: 81pt; TEXT-INDENT: -27pt"><span style="font-size:+0;">3. Procedures<o:p></o:p></span></p><p class="MsoNormal" style="MARGIN-LEFT: 81pt; TEXT-INDENT: -27pt"><span style="font-size:+0;">4. Computerized system<o:p></o:p></span></p><p class="MsoNormal"><o:p></o:p></p><p class="MsoNormal"><o:p></o:p></p><p class="MsoNormal"><b><u><br /><o:p></o:p></u></b></p><p class="MsoNormal" style="TEXT-ALIGN: center" align="center"><b><span lang="EN-GB">Documentation and Records</span></b><o:p></o:p></p><p class="MsoNormal"><o:p></o:p></p><p class="MsoNormal" style="MARGIN-LEFT: 0.5in; TEXT-INDENT: -0.25in; TEXT-ALIGN: justify"><span lang="EN-GB">A written or electronic data sheet should exist for each stored product indicating recommended storage conditions, any safety precautions to be observed and the shelf life. <o:p></o:p></span></p><p class="MsoNormal" style="MARGIN-LEFT: 0.5in; TEXT-INDENT: -0.25in; TEXT-ALIGN: justify"><span lang="EN-GB">Written procedures should describe the different operations which may affect the quality of the products or of the distribution activity. <o:p></o:p></span></p><p class="MsoNormal" style="MARGIN-LEFT: 0.5in; TEXT-INDENT: -0.25in; TEXT-ALIGN: justify"><span lang="EN-GB">Records should be made at the time each operation is taken and in such a way that all significant activities or events are traceable. Records should be clear and readily available. Records should be retained for a period of five years at least.<o:p></o:p></span></p><p class="MsoNormal"><span lang="EN-GB"><o:p></o:p></span></p><p class="MsoNormal"><span lang="EN-GB"><o:p></o:p></span></p><p class="MsoNormal"><b><u><o:p><span style="TEXT-DECORATION: none"><br /></span></o:p></u></b></p><br /><p class="MsoNormal"><b><u><o:p><span style="TEXT-DECORATION: none"></span><br /></o:p></u></b></p><p class="MsoNormal" style="TEXT-ALIGN: center" align="center"><b><span lang="EN-GB">Procedures<o:p></o:p></span></b></p><p class="MsoNormal"><span lang="EN-GB"><o:p></o:p></span></p><p class="MsoNormal" style="TEXT-ALIGN: justify"><span lang="EN-GB">Each procedure should be approved, signed, and dated by the person responsible for the quality system. The following procedure should be developed. <o:p></o:p></span></p><p class="MsoNormal" style="TEXT-INDENT: 63pt; TEXT-ALIGN: justify"><span lang="EN-GB">1.<span style="font-size:+0;"> </span>Receipt of incoming product<o:p></o:p></span></p><p class="MsoNormal" style="TEXT-INDENT: 63pt; TEXT-ALIGN: justify"><span lang="EN-GB">2.<span style="font-size:+0;"> </span>Processing orders<o:p></o:p></span></p><p class="MsoNormal" style="TEXT-INDENT: 63pt; TEXT-ALIGN: justify"><span lang="EN-GB">3.<span style="font-size:+0;"> </span>Stock movement and control <o:p></o:p></span></p><p class="MsoNormal" style="TEXT-INDENT: 63pt; TEXT-ALIGN: justify"><span lang="EN-GB">4.<span style="font-size:+0;"> </span>Thefts, losses and discrepancies in inventory<o:p></o:p></span></p><p class="MsoNormal" style="TEXT-INDENT: 63pt; TEXT-ALIGN: justify"><span lang="EN-GB">5.<span style="font-size:+0;"> </span>Returned goods<o:p></o:p></span></p><p class="MsoNormal" style="TEXT-INDENT: 63pt; TEXT-ALIGN: justify"><span lang="EN-GB">6.<span style="font-size:+0;"> </span>Recall <o:p></o:p></span></p><p class="MsoNormal" style="TEXT-INDENT: 63pt; TEXT-ALIGN: justify"><span lang="EN-GB">7.<span style="font-size:+0;"> </span>Complaints<o:p></o:p></span></p><p class="MsoNormal" style="TEXT-INDENT: 63pt"><span lang="EN-GB">8.<span style="font-size:+0;"> </span>Disposal of unsaleable goods<o:p></o:p></span></p><p class="MsoNormal" style="TEXT-INDENT: 63pt"><span lang="EN-GB">9.<span style="font-size:+0;"> </span>Repacking and labelling<o:p></o:p></span></p><p class="MsoNormal" style="TEXT-INDENT: 63pt"><span lang="EN-GB">10.Deviation<o:p></o:p></span></p><p class="MsoNormal" style="TEXT-INDENT: 63pt"><span lang="EN-GB">11.Change control<o:p></o:p></span></p><p class="MsoNormal"><span lang="EN-GB"><o:p></o:p></span></p><p class="MsoNormal" style="TEXT-ALIGN: center" align="center"><b><u><o:p><span style="TEXT-DECORATION: none"></span></o:p></u><span lang="EN-GB">Receipt of incoming product</span></b><o:p></o:p></p><p class="MsoNormal"><span lang="EN-GB"><o:p></o:p></span></p><p class="MsoNormal" style="MARGIN-LEFT: 0.5in; TEXT-INDENT: -0.25in; TEXT-ALIGN: justify"><span lang="EN-GB">Visually examine for identity against the relevant supplier’s documentation<o:p></o:p></span></p><p class="MsoNormal" style="MARGIN-LEFT: 0.5in; TEXT-INDENT: -0.25in; TEXT-ALIGN: justify"><span lang="EN-GB">Visually examine for damage<o:p></o:p></span></p><p class="MsoNormal" style="MARGIN-LEFT: 0.5in; TEXT-INDENT: -0.25in; TEXT-ALIGN: justify"><span lang="EN-GB">Sub-divide according to batch numbers if more than one batch<o:p></o:p></span></p><p class="MsoNormal" style="MARGIN-LEFT: 0.5in; TEXT-INDENT: -0.25in; TEXT-ALIGN: justify"><span lang="EN-GB"><span style="font-size:+0;"> </span>Reject product if damage or otherwise unfit for receipt/ distribution<o:p></o:p></span></p><p class="MsoNormal" style="MARGIN-LEFT: 0.5in; TEXT-INDENT: -0.25in; TEXT-ALIGN: justify"><span lang="EN-GB"><span style="font-size:+0;"> </span>Define the record-keeping process identifying<o:p></o:p></span></p><p class="MsoNormal" style="MARGIN-LEFT: 117pt; TEXT-INDENT: -45pt; TEXT-ALIGN: justify"><span lang="EN-GB"><span style="font-size:+0;"></span>- <span style="font-size:+0;"></span>source of drug,<o:p></o:p></span></p><p class="MsoNormal" style="MARGIN-LEFT: 117pt; TEXT-INDENT: -45pt; TEXT-ALIGN: justify"><span lang="EN-GB"><span style="font-size:+0;"></span>- <span style="font-size:+0;"></span>name and address of seller and transferor<o:p></o:p></span></p><p class="MsoNormal" style="MARGIN-LEFT: 117pt; TEXT-INDENT: -45pt; TEXT-ALIGN: justify"><span lang="EN-GB"><span style="font-size:+0;"></span>- <span style="font-size:+0;"></span>identity of drug<o:p></o:p></span></p><p class="MsoNormal" style="MARGIN-LEFT: 117pt; TEXT-INDENT: -45pt; TEXT-ALIGN: justify"><span lang="EN-GB"><span style="font-size:+0;"></span>- <span style="font-size:+0;"></span>quantity<o:p></o:p></span></p><p class="MsoNormal" style="MARGIN-LEFT: 117pt; TEXT-INDENT: -45pt; TEXT-ALIGN: justify"><span lang="EN-GB"><span style="font-size:+0;"></span>- <span style="font-size:+0;"></span>date of receipt and disposition<o:p></o:p></span></p><p class="MsoNormal" style="MARGIN-LEFT: 0.5in; TEXT-INDENT: -0.25in; TEXT-ALIGN: justify"><span lang="EN-GB">Handle high security materials (control drug, high value items, products requiring a specific storage temperature)<o:p></o:p></span></p><p class="MsoNormal"><span lang="EN-GB"><o:p></o:p></span></p><p class="MsoNormal"><span lang="EN-GB"><o:p></o:p></span></p><p class="MsoNormal"><b><u><br /><o:p></o:p></u></b></p><p class="MsoNormal" style="TEXT-ALIGN: center" align="center"><b><span lang="EN-GB">Processing orders</span></b><o:p></o:p></p><p class="MsoNormal"><span lang="EN-GB"><o:p></o:p></span></p><p class="MsoNormal" style="MARGIN-LEFT: 0.5in; TEXT-INDENT: -0.25in; TEXT-ALIGN: justify"><span lang="EN-GB">Formal sales order or formal records of customer’s order requirements<o:p></o:p></span></p><p class="MsoNormal" style="MARGIN-LEFT: 0.5in; TEXT-INDENT: -0.25in; TEXT-ALIGN: justify"><span lang="EN-GB">Despatch documents should contained as a minimum:<o:p></o:p></span></p><p class="MsoNormal" style="TEXT-ALIGN: justify"><span lang="EN-GB"><span style="font-size:+0;"></span>- <span style="font-size:+0;"></span>date of despatch,<o:p></o:p></span></p><p class="MsoNormal" style="MARGIN-LEFT: 81pt; TEXT-INDENT: 9pt; TEXT-ALIGN: justify"><span lang="EN-GB">- <span style="font-size:+0;"></span>customer’s name and address,<o:p></o:p></span></p><p class="MsoNormal" style="MARGIN-LEFT: 81pt; TEXT-INDENT: 9pt; TEXT-ALIGN: justify"><span lang="EN-GB">- <span style="font-size:+0;"></span>product name/ form/ lot number/ expiry date/ quantity sent,<o:p></o:p></span></p><p class="MsoNormal" style="MARGIN-LEFT: 81pt; TEXT-INDENT: 9pt; TEXT-ALIGN: justify"><span lang="EN-GB">- <span style="font-size:+0;"></span>any special handling or storage instruction,<o:p></o:p></span></p><p class="MsoNormal" style="MARGIN-LEFT: 81pt; TEXT-INDENT: 9pt; TEXT-ALIGN: justify"><span lang="EN-GB">-<span style="font-size:+0;"> </span>additional information according to local or international <o:p></o:p></span></p><p class="MsoNormal" style="MARGIN-LEFT: 81pt; TEXT-INDENT: 9pt; TEXT-ALIGN: justify"><span lang="EN-GB"><span style="font-size:+0;"></span>regulation,<o:p></o:p></span></p><p class="MsoNormal" style="MARGIN-LEFT: 0.5in; TEXT-INDENT: -0.25in; TEXT-ALIGN: justify"><b><span lang="EN-GB"><span style="font-size:+0;"> </span></span></b><span lang="EN-GB">Visually examine for identity<o:p></o:p></span></p><p class="MsoNormal" style="MARGIN-LEFT: 0.5in; TEXT-INDENT: -0.25in; TEXT-ALIGN: justify"><span lang="EN-GB"><span style="font-size:+0;"> </span>Visually examine for damage <o:p></o:p></span></p><p class="MsoNormal" style="MARGIN-LEFT: 0.5in; TEXT-INDENT: -0.25in; TEXT-ALIGN: justify"><span lang="EN-GB">Not shipped if these requirements are not met <o:p></o:p></span></p><p class="MsoNormal"><span lang="EN-GB"><o:p></o:p></span></p><p class="MsoNormal"><span lang="EN-GB"><o:p></o:p></span></p><p class="MsoNormal"><b><u><o:p><span style="TEXT-DECORATION: none"></span></o:p></u></b></p><p class="MsoNormal" style="TEXT-ALIGN: center" align="center"><b><span lang="EN-GB">Stock rotation and control</span></b><o:p></o:p></p><p class="MsoNormal"><span lang="EN-GB"><o:p></o:p></span></p><p class="MsoNormal" style="MARGIN-LEFT: 0.5in; TEXT-INDENT: -0.25in; TEXT-ALIGN: justify"><span lang="EN-GB">Define process by which product stock should be issued (first in -first out) and any exceptions to process<span style="font-size:+0;"> </span>(specific demands from a specific batch) <o:p></o:p></span></p><p class="MsoNormal" style="MARGIN-LEFT: 0.5in; TEXT-INDENT: -0.25in; TEXT-ALIGN: justify"><span lang="EN-GB">Define when periodic stock reconciliation should be performed <o:p></o:p></span></p><p class="MsoNormal" style="MARGIN-LEFT: 0.5in; TEXT-INDENT: -0.25in; TEXT-ALIGN: justify"><span lang="EN-GB">Define process to be used to investigate any significant stock discrepancies<o:p></o:p></span></p><p class="MsoNormal" style="MARGIN-LEFT: 0.5in; TEXT-INDENT: -0.25in; TEXT-ALIGN: justify"><span lang="EN-GB"><span style="font-size:+0;"> </span>Define a process of identifying outdated stock and moving it to a quarantine area<o:p></o:p></span></p><p class="MsoNormal"><span lang="EN-GB"><o:p></o:p></span></p><p class="MsoNormal" style="TEXT-ALIGN: center" align="center"><b><u><o:p><span style="TEXT-DECORATION: none"></span></o:p></u><span lang="EN-GB">Thefts, losses and discrepancies in inventory<o:p></o:p></span></b></p><p class="MsoNormal"><span lang="EN-GB"><o:p></o:p></span></p><p class="MsoNormal" style="MARGIN-LEFT: 0.5in; TEXT-INDENT: -0.25in; TEXT-ALIGN: justify"><span lang="EN-GB">Conduct a thorough investigation and document all action <o:p></o:p></span></p><p class="MsoNormal" style="MARGIN-LEFT: 0.5in; TEXT-INDENT: -0.25in; TEXT-ALIGN: justify"><span lang="EN-GB">Record losses, thefts or diversions and notify appropriate corporate personnel <o:p></o:p></span></p><p class="MsoNormal" style="MARGIN-LEFT: 0.5in; TEXT-INDENT: -0.25in; TEXT-ALIGN: justify"><span lang="EN-GB">Take measures to address the cause of theft, loss or diversion<span style="font-size:+0;"> </span></span><o:p></o:p></p><p class="MsoNormal"><o:p></o:p></p><p class="MsoNormal"><o:p></o:p></p><p class="MsoNormal"><br /><span lang="EN-GB"><o:p></o:p></span></p><p class="MsoNormal" style="TEXT-ALIGN: center" align="center"><b><span lang="EN-GB">Returned goods</span></b><o:p></o:p></p><p class="MsoNormal"><o:p></o:p></p><p class="MsoNormal" style="MARGIN-LEFT: 0.5in; TEXT-INDENT: -0.25in; TEXT-ALIGN: justify"><span lang="EN-GB">Products which have left the control of the wholesaler, should only be returned to saleable stock if:<o:p></o:p></span></p><p class="MsoNormal" style="TEXT-ALIGN: justify"><span lang="EN-GB"><o:p></o:p></span></p><p class="MsoNormal" style="TEXT-ALIGN: justify"><span lang="EN-GB"><span style="font-size:+0;"></span>- the goods are in their original unopened containers and <span style="font-size:+0;"></span>in good condition, <o:p></o:p></span></p><p class="MsoNormal" style="TEXT-ALIGN: justify"><span lang="EN-GB"><span style="font-size:+0;"></span>- it is known that the goods have been stored and handled under proper conditions,<o:p></o:p></span></p><p class="MsoNormal" style="TEXT-ALIGN: justify"><span lang="EN-GB"><span style="font-size:+0;"></span><span style="font-size:+0;"></span>- the remaining shelf life period is acceptable,<o:p></o:p></span></p><p class="MsoNormal" style="TEXT-ALIGN: justify"><span lang="EN-GB"><span style="font-size:+0;"></span>- they have been examined and assessed by a person authorised to do so,<o:p></o:p></span></p><p class="MsoNormal" style="TEXT-ALIGN: justify"><span lang="EN-GB"><span style="font-size:+0;"></span>- special attention should be given to products requiring special <span style="font-size:+0;"></span>storage<span style="font-size:+0;"> </span>conditions.<o:p></o:p></span></p><p class="MsoNormal" style="TEXT-ALIGN: justify"><span lang="EN-GB"><o:p></o:p></span></p><p class="MsoNormal" style="MARGIN-LEFT: 0.5in; TEXT-INDENT: -0.25in; TEXT-ALIGN: justify"><span lang="EN-GB">All returned goods should be kept apart from saleable stock<span style="font-size:+0;"> </span>until approved by a nominated responsible person <o:p></o:p></span></p><p class="MsoNormal" style="MARGIN-LEFT: 0.5in; TEXT-INDENT: -0.25in; TEXT-ALIGN: justify"><span lang="EN-GB"><span style="font-size:+0;"> </span>Records of returns should be kept,<span style="font-size:+0;"> </span>the responsible person should formally release goods to be returned to stock<o:p></o:p></span></p><p class="MsoNormal" style="TEXT-ALIGN: justify"><span lang="EN-GB"><o:p></o:p></span></p><p class="MsoNormal"><o:p></o:p><span lang="EN-GB"><o:p></o:p></span></p><p class="MsoNormal" style="TEXT-ALIGN: center" align="center"><b>Recall<o:p></o:p></b></p><p class="MsoNormal" style="TEXT-ALIGN: justify"><o:p></o:p></p><p class="MsoNormal" style="MARGIN-LEFT: 0.5in; TEXT-INDENT: -0.25in; TEXT-ALIGN: justify"><span lang="EN-GB">Products can only be recalled by decision of the Head of Quality Assurance<o:p></o:p></span></p><p class="MsoNormal" style="MARGIN-LEFT: 0.5in; TEXT-INDENT: -0.25in; TEXT-ALIGN: justify"><span lang="EN-GB">Define who contacts regulatory authorities concerning any recall</span><span lang="EN-GB"> </span><span lang="EN-GB"><o:p></o:p></span></p><p class="MsoNormal" style="MARGIN-LEFT: 0.5in; TEXT-INDENT: -0.25in; TEXT-ALIGN: justify"><span lang="EN-GB">Define the means whereby recalled products can be traced and obtained from the market<o:p></o:p></span></p><p class="MsoNormal" style="MARGIN-LEFT: 0.5in; TEXT-INDENT: -0.25in; TEXT-ALIGN: justify"><span lang="EN-GB">Establish records of any recalled products<o:p></o:p></span></p><p class="MsoNormal" style="MARGIN-LEFT: 0.5in; TEXT-INDENT: -0.25in; TEXT-ALIGN: justify"><span lang="EN-GB">Establish segregated storage area for any recalled products<o:p></o:p></span></p><p class="MsoNormal" style="MARGIN-LEFT: 0.5in; TEXT-INDENT: -0.25in; TEXT-ALIGN: justify"><span lang="EN-GB">Remove recalled product from saleable stock and store in a segregated area<o:p></o:p></span></p><p class="MsoNormal" style="MARGIN-LEFT: 0.5in; TEXT-INDENT: -0.25in; TEXT-ALIGN: justify"><span lang="EN-GB">Only relevant QA Manager or responsible person could make decision on recalled product fate<o:p></o:p></span></p><p class="MsoNormal" style="MARGIN-LEFT: 0.5in; TEXT-INDENT: -0.25in; TEXT-ALIGN: justify"><span lang="EN-GB">The effectiveness of the arrangements for recalls should be<span style="font-size:+0;"> </span>evaluated from time to time<o:p></o:p></span></p><p class="MsoNormal"><o:p></o:p></p><p class="MsoNormal"><o:p></o:p></p><p class="MsoNormal"><o:p></o:p></p><p class="MsoNormal"><o:p></o:p><span lang="EN-GB"><o:p></o:p></span></p><p class="MsoNormal" style="TEXT-ALIGN: center" align="center"><b>Complaints<o:p></o:p></b></p><p class="MsoNormal"><o:p></o:p></p><p class="MsoNormal" style="MARGIN-LEFT: 0.5in; TEXT-INDENT: -0.25in; TEXT-ALIGN: justify"><span lang="EN-GB">Any complaint concerning a product defect must be immediately reported to supplier and processed according to local regulations<span style="font-size:+0;"> </span><o:p></o:p></span></p><p class="MsoNormal" style="MARGIN-LEFT: 0.5in; TEXT-INDENT: -0.25in; TEXT-ALIGN: justify"><span lang="EN-GB">Complaints relating to customer service or shipping<span style="font-size:+0;"> </span>errors should be processed according to established procedure <o:p></o:p></span></p><p class="MsoNormal" style="MARGIN-LEFT: 0.5in; TEXT-INDENT: -0.25in; TEXT-ALIGN: justify"><span lang="EN-GB"><span style="font-size:+0;"> </span>Each received complaint should be recorded<o:p></o:p></span></p><p class="MsoNormal" style="TEXT-ALIGN: justify"><span lang="EN-GB"><o:p></o:p></span></p><p class="MsoNormal"><span lang="EN-GB"><o:p></o:p></span></p><p class="MsoNormal"><br /><span lang="EN-GB"><o:p></o:p></span></p><p class="MsoNormal" style="TEXT-ALIGN: center" align="center"><b><span lang="EN-GB">Disposal of unsaleable goods<o:p></o:p></span></b></p><p class="MsoNormal"><span lang="EN-GB"><o:p></o:p></span></p><p class="MsoNormal" style="MARGIN-LEFT: 0.5in; TEXT-INDENT: -0.25in; TEXT-ALIGN: justify"><span lang="EN-GB">Stock which is no longer fit for sale must be segregated from other stock before ultimate disposal or destruction <o:p></o:p></span></p><p class="MsoNormal" style="MARGIN-LEFT: 0.5in; TEXT-INDENT: -0.25in; TEXT-ALIGN: justify"><span lang="EN-GB">Destruction of unsaleable goods must be carried out in<span style="font-size:+0;"> </span>accordance with local legislation or guidelines issued by each manufacturer <o:p></o:p></span></p><p class="MsoNormal" style="MARGIN-LEFT: 0.5in; TEXT-INDENT: -0.25in; TEXT-ALIGN: justify"><span lang="EN-GB">There must be a written record kept of all goods destroyed showing product name, batch number, pack size, quantity and methods of destruction<o:p></o:p></span></p><p class="MsoNormal"><span lang="EN-GB"><o:p></o:p></span></p><p class="MsoNormal" style="TEXT-ALIGN: center" align="center"><b><span lang="EN-GB">Repacking and labelling</span></b><o:p></o:p></p><p class="MsoNormal"><span lang="EN-GB"><o:p></o:p></span></p><p class="MsoNormal" style="TEXT-ALIGN: justify"><u><span lang="EN-GB">Wherever possible, repacking and labelling process should be carried out at the Principal’s own licensed premises.<o:p></o:p></span></u></p><p class="MsoNormal" style="TEXT-ALIGN: justify"><span lang="EN-GB"><o:p></o:p></span></p><p class="MsoNormal" style="TEXT-ALIGN: justify"><span lang="EN-GB">In any necessary case of carrying out repacking or labelling process at wholesaler site following factors must be applied: </span><span lang="EN-GB"><span style="font-size:+0;"></span></span><span lang="EN-GB"><o:p></o:p></span></p><p class="MsoNormal" style="MARGIN-LEFT: 0.5in; TEXT-INDENT: -0.25in; TEXT-ALIGN: justify"><span lang="EN-GB"><span style="font-size:+0;"> </span>dedicated area for this operation,<o:p></o:p></span></p><p class="MsoNormal" style="MARGIN-LEFT: 0.5in; TEXT-INDENT: -0.25in; TEXT-ALIGN: justify"><span lang="EN-GB">adequate procedure described operation,<o:p></o:p></span></p><p class="MsoNormal" style="MARGIN-LEFT: 0.5in; TEXT-INDENT: -0.25in; TEXT-ALIGN: justify"><span lang="EN-GB"><span style="font-size:+0;"> </span>each step of the operation should be recorded,<span style="font-size:+0;"> </span>records should <o:p></o:p></span></p><p class="MsoNormal" style="TEXT-ALIGN: justify"><span lang="EN-GB"><span style="font-size:+0;"></span>also contain identification and quantity of product<span style="font-size:+0;"> </span>and packaging materials<o:p></o:p></span></p><p class="MsoNormal" style="MARGIN-LEFT: 0.5in; TEXT-INDENT: -0.25in; TEXT-ALIGN: justify"><span lang="EN-GB">all work should be supervised by Principal’s QC or QA <o:p></o:p></span></p><p class="MsoNormal" style="TEXT-ALIGN: justify"><span lang="EN-GB"><span style="font-size:+0;"></span>representative<o:p></o:p></span></p><p class="MsoNormal"><span lang="EN-GB"><o:p></o:p></span></p><p class="MsoNormal"><span lang="EN-GB"><o:p></o:p></span><span lang="EN-GB"><o:p></o:p></span></p><p class="MsoNormal" style="TEXT-ALIGN: center" align="center"><b><span lang="EN-GB">Deviation<o:p></o:p></span></b></p><p class="MsoNormal"><span lang="EN-GB"><o:p></o:p></span></p><p class="MsoNormal" style="TEXT-ALIGN: justify"><span lang="EN-GB">Deviation is defined as an accidental departure from established<span style="font-size:+0;"> </span>process described in procedures.<o:p></o:p></span></p><p class="MsoNormal" style="TEXT-ALIGN: justify"><span lang="EN-GB">Each site should develop a written procedure for processing deviation. Deviation Procedure should include:<o:p></o:p></span></p><p class="MsoNormal" style="MARGIN-LEFT: 1in; TEXT-ALIGN: justify"><span lang="EN-GB">-<span style="font-size:+0;"> </span>identification of deviation,<o:p></o:p></span></p><p class="MsoNormal" style="MARGIN-LEFT: 1in; TEXT-ALIGN: justify"><span lang="EN-GB">- <span style="font-size:+0;"></span>impact of deviation<span style="font-size:+0;"> </span>for safety, identity, strength, purity or quality,</span><span lang="EN-GB"> </span><span lang="EN-GB"><o:p></o:p></span></p><p class="MsoNormal" style="MARGIN-LEFT: 1in; TEXT-ALIGN: justify"><span lang="EN-GB">- <span style="font-size:+0;"></span>investigation of root cause if rationale,<o:p></o:p></span></p><p class="MsoNormal" style="MARGIN-LEFT: 1in; TEXT-ALIGN: justify"><span lang="EN-GB">- <span style="font-size:+0;"></span>corrective action,<o:p></o:p></span></p><p class="MsoNormal" style="MARGIN-LEFT: 1in; TEXT-ALIGN: justify"><span lang="EN-GB">- <span style="font-size:+0;"></span>preventative action,<o:p></o:p></span></p><p class="MsoNormal" style="MARGIN-LEFT: 1in; TEXT-ALIGN: justify"><span lang="EN-GB">- <span style="font-size:+0;"></span>records of deviation<o:p></o:p></span></p><p class="MsoNormal"><span lang="EN-GB"><o:p></o:p></span></p><p class="MsoNormal"><span lang="EN-GB"><o:p></o:p></span></p><p class="MsoNormal"><b><u><o:p><span style="TEXT-DECORATION: none"></span></o:p></u></b></p><p class="MsoNormal" style="TEXT-ALIGN: center" align="center"><b><span lang="EN-GB">Change control</span></b><o:p></o:p></p><p class="MsoNormal"><span lang="EN-GB"><o:p></o:p></span></p><p class="MsoNormal" style="TEXT-ALIGN: justify"><span lang="EN-GB">Change is defined as a planned alteration or replacement of items such as, but not limited to, the following:<o:p></o:p></span></p><p class="MsoNormal" style="TEXT-ALIGN: justify"><span lang="EN-GB"><o:p></o:p></span></p><p class="MsoNormal" style="TEXT-INDENT: 1in; TEXT-ALIGN: justify"><span lang="EN-GB">-<span style="font-size:+0;"> </span>buildings and facilities,<o:p></o:p></span></p><p class="MsoNormal" style="TEXT-INDENT: 1in; TEXT-ALIGN: justify"><span lang="EN-GB">- <span style="font-size:+0;"></span>equipment,<o:p></o:p></span></p><p class="MsoNormal" style="TEXT-INDENT: 1in; TEXT-ALIGN: justify"><span lang="EN-GB">- <span style="font-size:+0;"></span>storage and distribution procedure.<o:p></o:p></span></p><p class="MsoNormal" style="TEXT-INDENT: 1in; TEXT-ALIGN: justify"><span lang="EN-GB"><o:p></o:p></span></p><p class="MsoNormal" style="MARGIN-LEFT: 0.5in; TEXT-INDENT: -0.25in; TEXT-ALIGN: justify"><span lang="EN-GB">There should be Change Control SOP in place.<o:p></o:p></span></p><p class="MsoNormal" style="MARGIN-LEFT: 0.5in; TEXT-INDENT: -0.25in; TEXT-ALIGN: justify"><span lang="EN-GB"><span style="font-size:+0;"> </span>The change must be described and justified.<o:p></o:p></span></p><p class="MsoNormal" style="MARGIN-LEFT: 0.5in; TEXT-INDENT: -0.25in; TEXT-ALIGN: justify"><span lang="EN-GB"><span style="font-size:+0;"> </span>Determine the impact of the change for various areas.<o:p></o:p></span></p><p class="MsoNormal" style="MARGIN-LEFT: 0.5in; TEXT-INDENT: -0.25in; TEXT-ALIGN: justify"><span lang="EN-GB"><span style="font-size:+0;"> </span>The proposed change must be reviewed by affected areas.<o:p></o:p></span></p><p class="MsoNormal" style="MARGIN-LEFT: 0.5in; TEXT-INDENT: -0.25in; TEXT-ALIGN: justify"><span lang="EN-GB"><span style="font-size:+0;"> </span>The change is executed in co-operation with affected areas.<o:p></o:p></span></p><p class="MsoNormal" style="MARGIN-LEFT: 0.5in; TEXT-INDENT: -0.25in; TEXT-ALIGN: justify"><span lang="EN-GB">Prior to filing the documentation , an appropriate person must review and approve the completed change to ensure the documentation is complete and accurate.<o:p></o:p></span></p><p class="MsoNormal" style="MARGIN-LEFT: 0.5in; TEXT-INDENT: -0.25in; TEXT-ALIGN: justify"><span lang="EN-GB"><span style="font-size:+0;"> </span>Records of change must be retained.<o:p></o:p></span></p><p class="MsoNormal"><span lang="EN-GB"><o:p></o:p></span></p><p class="MsoNormal" style="TEXT-ALIGN: justify"><u><span lang="EN-GB">The distributor should inform supplier in advance of any significant change he is going to implement.<o:p></o:p></span></u></p><p class="MsoNormal" style="TEXT-ALIGN: justify"><span lang="EN-GB"><o:p></o:p></span></p><p class="MsoNormal"><b><u><o:p><span style="TEXT-DECORATION: none"></span></o:p></u></b><span lang="EN-GB"><o:p></o:p></span></p><p class="MsoNormal" style="TEXT-ALIGN: center" align="center"><b><span lang="PL">Computerized system</span></b><o:p></o:p></p><p class="MsoNormal"><span lang="EN-GB"><o:p></o:p></span></p><p class="MsoNormal" style="MARGIN-LEFT: 0.5in; TEXT-INDENT: -0.25in; TEXT-ALIGN: justify"><span lang="EN-GB"> Computer hardware<o:p></o:p></span></p><p class="MsoNormal" style="TEXT-ALIGN: justify"><span lang="EN-GB"><o:p></o:p></span></p><p class="MsoNormal" style="MARGIN-LEFT: 1.5in; TEXT-INDENT: -21pt; TEXT-ALIGN: justify"><span lang="EN-GB">- <span style="font-size:+0;"></span>detailed specification (model, version of all hardware, drawings of circuits, networks, routes),<o:p></o:p></span></p><p class="MsoNormal" style="TEXT-INDENT: 1in; TEXT-ALIGN: justify"><span lang="EN-GB"><span style="font-size:+0;"></span>- <span style="font-size:+0;"></span>maintenance<span style="font-size:+0;"> </span>(planned and breakdown),<o:p></o:p></span></p><p class="MsoNormal" style="TEXT-INDENT: 1in; TEXT-ALIGN: justify"><span lang="EN-GB"><span style="font-size:+0;"></span>- <span style="font-size:+0;"></span>location and environment,<o:p></o:p></span></p><p class="MsoNormal" style="TEXT-INDENT: 1in; TEXT-ALIGN: justify"><span lang="EN-GB"><span style="font-size:+0;"></span>- <span style="font-size:+0;"></span>change control<o:p></o:p></span></p><p class="MsoNormal" style="TEXT-INDENT: 1in; TEXT-ALIGN: justify"><span lang="EN-GB"><o:p></o:p></span></p><p class="MsoNormal" style="MARGIN-LEFT: 0.5in; TEXT-INDENT: -0.25in; TEXT-ALIGN: justify"><span lang="EN-GB">Computer Software<o:p></o:p></span></p><p class="MsoNormal" style="MARGIN-LEFT: 0.5in; TEXT-INDENT: -0.25in; TEXT-ALIGN: justify"><span lang="EN-GB"><span style="font-size:+0;"> </span>Specification should include :<o:p></o:p></span></p><p class="MsoNormal" style="MARGIN-LEFT: 99pt; TEXT-INDENT: -9pt; TEXT-ALIGN: justify"><span lang="EN-GB">- <span style="font-size:+0;"></span>the version number of all the programmes eg<span style="font-size:+0;"> </span>operating systems, source <span style="font-size:+0;"></span><o:p></o:p></span></p><p class="MsoNormal" style="TEXT-ALIGN: justify"><span lang="EN-GB"><span style="font-size:+0;"></span>codes, application languages etc. <o:p></o:p></span></p><p class="MsoNormal" style="MARGIN-LEFT: 1.5in; TEXT-INDENT: -0.25in; TEXT-ALIGN: justify"><span lang="EN-GB">-<span style="font-size:+0;"> </span>schematics /diagrams illustrating the main architecture of the programme and/or security detections, eg against unauthorised changes <o:p></o:p></span></p><p class="MsoNormal" style="MARGIN-LEFT: 1.5in; TEXT-INDENT: -0.25in; TEXT-ALIGN: justify"><span lang="EN-GB">-<span style="font-size:+0;"> </span>a programme listing, eg source codes and necessary back-up media, to enable re-installation of the same programme to occur in the event of breakdown etc.<o:p></o:p></span></p><p class="MsoNormal" style="MARGIN-LEFT: 0.5in; TEXT-INDENT: -0.25in; TEXT-ALIGN: justify"><span lang="EN-GB">All aspects of computer system should be described in adequate procedures<o:p></o:p></span></p><p class="MsoNormal" style="MARGIN-LEFT: 0.5in; TEXT-INDENT: -0.25in; TEXT-ALIGN: justify"><span lang="EN-GB"><span style="font-size:+0;"> </span>Every significant modification should be validated<o:p></o:p></span></p><p class="MsoNormal" style="MARGIN-LEFT: 0.5in; TEXT-INDENT: -0.25in; TEXT-ALIGN: justify"><span lang="EN-GB"><span style="font-size:+0;"> </span>Data should be protected by backing-up at regular intervals<o:p></o:p></span></p><p class="MsoNormal" style="MARGIN-LEFT: 0.5in; TEXT-INDENT: -0.25in; TEXT-ALIGN: justify"><span lang="EN-GB"><span style="font-size:+0;"> </span>Back-up data should be stored as long as necessary at a separate and secure location<o:p></o:p></span></p><p class="MsoNormal" style="MARGIN-LEFT: 0.5in; TEXT-INDENT: -0.25in; TEXT-ALIGN: justify"><span lang="EN-GB"><span style="font-size:+0;"> </span>Establish and validate procedure to be followed if system fails or breaks down <o:p></o:p></span></p><p class="MsoNormal" style="MARGIN-LEFT: 0.5in; TEXT-INDENT: -0.25in; TEXT-ALIGN: justify"><span lang="EN-GB"><span style="font-size:+0;"> </span>Any failures and remedial action taken should be recorded<o:p></o:p></span></p><p class="MsoNormal" style="MARGIN-LEFT: 0.5in; TEXT-INDENT: -0.25in; TEXT-ALIGN: justify"><span lang="EN-GB"><span style="font-size:+0;"> </span>Establish procedure to record and analyse errors and to enable corrective action to be taken<o:p></o:p></span></p><p class="MsoNormal" style="MARGIN-LEFT: 0.5in; TEXT-INDENT: -0.25in; TEXT-ALIGN: justify"><span lang="EN-GB">Implement adequate training program for operators</span><span lang="EN-GB"><o:p></o:p></span></p><p class="MsoNormal"><span style="font-family:';color:black;"><br /></span></p>shahzadhttp://www.blogger.com/profile/01364507074991292353noreply@blogger.comtag:blogger.com,1999:blog-7305327264533069235.post-90808879959599299632009-06-18T22:46:00.000-07:002009-06-18T22:54:30.959-07:00GOOD WAREHOUSING<p class="MsoNormal" style="text-align: center;" align="center"><b><span style="color:black;">Definitions<o:p></o:p></span></b></p> <p class="MsoNormal" style="text-align: justify;"><b><span style="color:black;"><o:p> </o:p></span></b></p> <p class="MsoNormal" style="text-align: justify;"><span style="color:black;">Warehouse - A facility where company stocks are stored. In Pharma business, typically store raw material, packaging material, semi finished and finished goods.<o:p></o:p></span></p> <p class="MsoNormal" style="text-align: justify;"><span style="color:black;"><o:p> </o:p></span></p> <p class="MsoNormal" style="text-align: justify;"><span style="color:black;">Distribution - The process in which the finished drug product is moved from the initial warehouse to the final consumer. This process may involve several steps from beginning to end depending on the complexity of any </span><span lang="EN-GB" style="color:black;">manufacturing</span><span style="color:black;"> /marketing agreements.<o:p></o:p></span></p> <p class="MsoNormal"><b style=""><o:p> </o:p></b></p> <p class="MsoNormal"><o:p> </o:p></p> <p class="MsoNormal"><b style=""><u><br /><o:p></o:p></u></b></p> <p class="MsoNormal" style="text-align: center;" align="center"><b>Licences<o:p></o:p></b></p> <p class="MsoNormal"><b><o:p> </o:p></b></p> <p class="MsoNormal" style="margin-left: 0in; text-align: justify; text-indent: 0in;"><!--[if !supportLists]--><span style="font-family:Wingdings;"><span style="">u<span style=";font-family:";font-size:7;" > </span></span></span><!--[endif]--><span style="">A potential warehousing and distribution organization must hold all<span style=""> </span><o:p></o:p></span></p> <p class="MsoNormal" style="text-align: justify;"><span style=""><span style=""> </span><span style=""> </span>necessary </span><span style="" lang="EN-GB">local</span><span style=""> government licences covering the storage<span style=""> </span>and/or </span><span style="" lang="EN-GB">distribution</span><span style=""><span style=""> </span><o:p></o:p></span></p> <p class="MsoNormal" style="text-align: justify;"><span style=""><span style=""> </span>of the relevant<span style=""> </span>drug products.<span style=""> </span><o:p></o:p></span></p> <p class="MsoNormal" style="margin-left: 0in; text-align: justify; text-indent: 0in;"><!--[if !supportLists]--><span style="font-family:Wingdings;"><span style="">u<span style=";font-family:";font-size:7;" > </span></span></span><!--[endif]--><span style="">Deliveries should be made only to other authorized </span><span style="" lang="EN-GB">wholesalers</span><span style=""> or the person<span style=""> </span><o:p></o:p></span></p> <p class="MsoNormal" style="text-align: justify;"><span style=""><span style=""> </span>authorised to supply medicinal<span style=""> </span></span><span style="" lang="EN-GB">products</span><span style=""> to the public in the country.<o:p></o:p></span></p> <p class="MsoNormal" style="text-align: right;" align="right"><i><span style=""><span style=""> </span><o:p></o:p></span></i></p><p class="MsoNormal"><b style=""><u><br /><o:p></o:p></u></b></p> <p class="MsoNormal" style="text-align: center;" align="center"><b style="">Personnel<o:p></o:p></b></p> <p class="MsoNormal" style="text-align: center;" align="center"><o:p> </o:p></p> <p class="MsoNormal" style="margin-left: 0in; text-indent: 0in;"><!--[if !supportLists]--><span lang="EN-GB" style="font-family:Wingdings;"><span style="">u<span style=";font-family:";font-size:7;" > </span></span></span><!--[endif]--><span style="" lang="EN-GB">Key personnel who carry out supervisory and/or<span style=""> </span>controlling<span style=""> </span>functions relating to<span style=""> </span><span style=""> </span><o:p></o:p></span></p> <p class="MsoNormal"><span style="" lang="EN-GB"><span style=""> </span>warehousing or distribution should possess the necessary integrity, knowledge, <span style=""> </span><o:p></o:p></span></p> <p class="MsoNormal"><span style="" lang="EN-GB"><span style=""> </span>experience, and<span style=""> </span>professional or technical qualifications appropriate to the task<o:p></o:p></span></p> <p class="MsoNormal" style=""><span style="" lang="EN-GB"><span style=""> </span>assigned to them. <span style=""> </span></span><span style=""><o:p></o:p></span></p> <p class="MsoNormal" style="margin-left: 0in; text-indent: 0in;"><!--[if !supportLists]--><span lang="EN-GB" style="font-family:Wingdings;"><span style="">u<span style=";font-family:";font-size:7;" > </span></span></span><!--[endif]--><span style="" lang="EN-GB">The concept of the Responsible Person (RP) was introduced by the Directive <span style=""> </span><o:p></o:p></span></p> <p class="MsoNormal"><span style="" lang="EN-GB"><span style=""> </span>2/25/EEC.<span style=""> </span>The RP should ensure that the conditions of the Wholesale Dealer’s <span style=""> </span><o:p></o:p></span></p> <p class="MsoNormal"><span style="" lang="EN-GB"><span style=""> </span>Licence are met and that the guidelines on Good Distribution Practice are <span style=""> </span><o:p></o:p></span></p> <p class="MsoNormal"><span style="" lang="EN-GB"><span style=""> </span>complied with. <o:p></o:p></span></p> <p class="MsoNormal"><b style=""><u><o:p><span style="text-decoration: none;"> </span><br /></o:p></u></b></p> <p class="MsoNormal"><b style=""><u><o:p><span style="text-decoration: none;"> </span></o:p></u></b></p> <p class="MsoNormal" style="margin-left: 0.25in; text-indent: -0.25in;"><!--[if !supportLists]--><span lang="EN-GB" style="font-family:Wingdings;"><span style="">u<span style=";font-family:";font-size:7;" > </span></span></span><!--[endif]--><span style=""><span style=""> </span><span lang="EN-GB">Personnel should be trained in relation to good storage and distribution practice and to the duties assigned to them. <u>All training should be documented.<o:p></o:p></u></span></span></p> <p class="MsoNormal" style="margin-left: 0.5in; text-indent: -0.25in;"><!--[if !supportLists]--><span lang="EN-GB" style="font-family:Wingdings;"><span style="">u<span style=";font-family:";font-size:7;" > </span></span></span><!--[endif]--><span style="" lang="EN-GB"><span style=""> </span>The following aspects should be included in any formal training programme:<o:p></o:p></span></p> <p class="MsoNormal" style="margin-left: 63pt;"><span style="" lang="EN-GB"><span style=""> </span>- Regulatory Requirements<o:p></o:p></span></p> <p class="MsoNormal" style="margin-left: 63pt;"><span style="" lang="EN-GB"><span style=""> </span>- Standard Operating Procedures<o:p></o:p></span></p> <p class="MsoNormal" style="margin-left: 63pt;"><span style="" lang="EN-GB"><span style=""> </span>- Record-keeping<o:p></o:p></span></p> <p class="MsoNormal" style="margin-left: 63pt;"><span style="" lang="EN-GB"><span style=""> </span>- Security<o:p></o:p></span></p> <p class="MsoNormal" style="margin-left: 63pt;"><span style="" lang="EN-GB"><span style=""> </span>- Storage Requirements<o:p></o:p></span></p> <span style="" lang="EN-GB"><span style=""> </span>- Safety</span>shahzadhttp://www.blogger.com/profile/01364507074991292353noreply@blogger.comtag:blogger.com,1999:blog-7305327264533069235.post-79047533853237992732009-06-16T21:11:00.007-07:002009-06-19T21:54:09.746-07:00Safe Chemical Storage PracticesSafety Cabinets<br />Acetaldehyde, acetic acid, cadmium chlorate, copper(II) sulfide, hydrogen peroxide, iron(II) sulfide, sodium cyanide, sulfuric acid...<br />Alphabetizing is a skill most of us have used since childhood, yet it can be deadly if applied to the storage of laboratory chemicals. Polymerization, explosion, and the generation of highly toxic material could result if neighboring compounds reacted on the "alphabetical" shelf above.<br />Properly storing chemicals such as acids, bases, and flammable or combustible liquids is essential for maintaining a safe laboratory environment. It is important to grasp the guiding principles of chemical storage, and to explore the options available from manufacturers before you buy safety cabinets for the storage of laboratory chemicals.<br />Chemical storage guidelines<br />Information on storage requirements for a given chemical can be found in the MSDS, the manufacturer's label, and chemical reference materials. Together they can provide answers to questions such as: Is the chemical flammable or combustible? Is the chemical corrosive? And Is the chemical light-sensitive? Once such information has been obtained, the appropriate place and method of storage can be determined.<br />Perhaps the single most important rule in chemical storage is to segregate incompatible chemicals, which could cause fire, explosion, or the generation of toxic gases. For example, acids must not be stored with bases, and oxidizers must not be stored with reducing agents or flammable materials. Chemicals that pose more than one type of hazard may require special storage arrangements.<br />Storing the least amount of each chemical as possible is also very important. Most chemical suppliers now offer "just-in-time" delivery, so that users can order only the amount of chemical needed for a current task and receive the order at the time it is needed. A good inventory control system also helps minimize the amounts of chemicals being stored by preventing unnecessary purchases.<br />Flammable and combustible liquids<br />At UST, CLS maintains a stock of commonly used chemicals and makes prompt deliveries to users, thus eliminating the need for PIs to over stock chemicals in their labs. Acids and corrosives Acids and corrosives While there are no specific regulatory requirements for the storage of nonflammable acids and alkaline corrosives, good storage practices dictate that these chemicals be stored in dedicated, corrosion-resistant cabinets. Acids must be stored separately from bases, and chemical compatibility must be maintained within each dedicated cabinet. For example, acetic acid and nitric acid can react explosively and must be isolated from one another if stored within the same safety cabinet. (Note: Organic acids, such as acetic acid, should be stored with organic solvents instead of inorganic acids.)<br />Cabinets for acids and corrosives are generally constructed of laminated or epoxy-painted plywood, high density polyethylene, or polypropylene. Epoxy-coated steel cabinets are also available; however, their use is not recommended with nitric or sulfuric acids. With these chemicals, the vapors that emanate from the stored containers contribute strongly to the degradation of metal cabinets. In the case of these two common materials, the former plywood or polymer cabinets should be utilized. It should also be noted that many cabinets also feature metal-free hinge assemblies.<br />Users should conduct periodic inspection and cleaning (with a neutralizing compound plus soap and water) of all safety cabinets. Look for signs of corrosion within the cabinet and carefully check trays, hinges, locks and metal shelf clips. It is important to remember that the performance of a cabinet will be compromised by corroded or improperly functioning parts.<br />Flammable and combustible liquids<br />Flammable liquids have flash points below 37.8¢XC (100¢XF). Those with flash points above 37.8¢XC are "combustibles". Flash point is the minimum temperature at which a liquid gives off vapor within a test vessel in sufficient concentration to form an ignitable mixture with air near the surface of the liquid. According to the HK Fire Services Department regulations, each user must not have more than 120 liters (aggregate) of flammable materials stored outside of licensed Dangerous Goods Stores (for diethyl ether or diisopropyl ether, the aggregate value drops to 2.5 liters). In the case of temporary storage in the laboratory, the quantity must be minimized to meet only daily requirements and shall not at any time exceed the above stated limit. Furthermore, flammable materials are to be stored in appropriate flammable storage cabinets in the laboratory.<br />(Some of the information in this article was excerpted from Chemical Health and Safety, Vol. 4, No. 4, Jul/Aug 1997, p.33-36.)shahzadhttp://www.blogger.com/profile/01364507074991292353noreply@blogger.comtag:blogger.com,1999:blog-7305327264533069235.post-45968333935681525502009-06-16T21:11:00.006-07:002009-06-19T21:49:56.919-07:00MINOR STORAGES OF DANGEROUS GOODSMINOR STORAGES OF DANGEROUS GOODS<br />37. What are minor storages?<br />Minor storages are dangerous goods storages in quantities below the “Placarding Quantity” in<br />Schedule 2 of the Regulations. A premises could have a number of such storages and this Part<br />would be applicable to each storage<br />38. Relationship with other Parts of this Code<br />This Part of the Code only applies to minor storages of dangerous goods (other than<br />dangerous goods on display for retail sale for which part 4 applies).<br />If this Part of the Code applies to your premises, you will be in compliance with the<br />Regulations if you follow the guidance in this Part. You do not need to refer to Part 3 of the<br />Code (except where noted).<br />39. Risk management for minor storages<br />39.1 Hazard identification<br />It is sufficient compliance with Regulation 404 in relation to each minor storage if you<br />prepare a list of all the dangerous goods in each minor storage that includes:<br />· the name of each of the dangerous goods;<br />· the Class, Subsidiary Risk and Packing Group of each of the dangerous goods, and<br />· a summary of the hazards identified in the MSDS for each of the dangerous goods<br />The MSDS must be obtained for each of the dangerous goods at the premises. The MSDS<br />provides the hazard information on the dangerous goods.<br />39.2 Risk assessment<br />It is sufficient compliance with Regulation 405 in relation to each minor storage for youto:<br />· review the MSDS for each of the dangerous goods kept in each minor storage; and<br />· document the following broad types of risk associated with the dangerous goods in the<br />minor storage:<br />– fire and explosion risks associated with the storage and handling of flammable gases<br />(Class 2.1 or Subsidiary Risk 2.1), flammable liquids (Class 3 or Subsidiary Risk 3),<br />dangerous goods of Class 4.1, 4.2 and 4.3 or Subsidiary Risk 4.1, 4.2 and 4.3, and<br />combustible liquids;<br />– fire risks that may result from the storage and handling of oxidising agents of Class 5.1<br />or Subsidiary Risk 5.1 or organic peroxides of Class 5.2;<br />– the toxic risks associated with dangerous goods of Class 6.1 or Subsidiary Risk 6.1; and<br />– the corrosive risks associated with dangerous goods of Class 8 or Subsidiary Risk 8.<br />69<br />39.3 Risk control<br />To control risk associated with minor storage of dangerous goods, implement the following<br />measures:<br />Minimise quantities kept<br />· Consider substituting the dangerous goods with other goods that have a lower risk<br />associated with their storage and handling. Examples of substitution are the use of:<br />- degreasing with a detergent instead of a chlorinated or volatile solvent;<br />- a combustible liquid such as diesel instead of petrol and kerosene which are Class 3<br />flammable liquids; and<br />- a dangerous good with a higher Packing Group number. An example is substituting<br />xylene (PGIII) for toluene (PGII).<br />· Ensure the quantity of dangerous goods kept at any one time is kept to a minimum<br />consistent with the operation of the premises.<br />Follow MSDS instructions<br />· Where the label or MSDS for a dangerous goods specifies measures and/or equipment to<br />be used for the storage and handling of the dangerous goods then you should adopt those<br />measures or use that equipment.<br />Storage and handling of packages<br />· Keep packages securely closed when not in use. They should be stored on surfaces that are<br />resistant to attack by their contents if spilt, and will not react dangerously with spilt<br />dangerous goods.<br />· Stow packages in a way that minimises the risk of them falling or being dislodged.<br />· Store packages so that leakage cannot adversely affect other dangerous goods in the<br />storage area. Liquid dangerous goods in packages should not be stored above solid<br />dangerous goods in paper or absorbent packaging. Glass containers of liquids should be<br />stored at lower levels.<br />· Where dangerous goods require special storage conditions to ensure their stability (ie to<br />eliminate the risk of hazardous reaction), make regular checks to ensure that these special<br />conditions are maintained. Examples of special storage conditions are the need for<br />stabilisers or refrigeration.<br />· Where aerosols are stored together in outer packaging, enclose the storage area in a strong<br />mesh enclosure to reduce the risk from projectiles in the event of a fire involving the<br />aerosols.<br />Transfer of dangerous goods<br />Where dangerous goods need to be transferred (by pumping, decanting, dispensing and<br />filling) into or from a container or moved from place to place in a minor storage area, ensure<br />70<br />that:<br />· spill containment is provided that can hold at least the quantity of the largest container;<br />· the container being filled and any transfer equipment is earthed, if there is a likelihood of<br />static electricity being generated and risk from ignition of flammable vapours during the<br />transfer;<br />· the transfer is done in a manner reduces the generation of any vapours and avoids<br />splashing or spillage of the dangerous goods;<br />· the place where the transfer is carried out is:<br />- set aside for that purpose;<br />- not within the storage area but adjacent to it;<br />- free of ignition sources;<br />- free of obstructions with sufficient room to enable the transfer to be carried out and to<br />hold containers and associated equipment;<br />· any decontamination materials or clean-up equipment is kept close by;<br />· where dangerous goods are to be transferred into containers at the premises, the container<br />is suitable and can’t be damaged by the dangerous goods. For example, don’t use a plastic<br />container that could be softened or made brittle by the dangerous goods;<br />The container receiving the transferred dangerous goods as part of a work process does not<br />require marking.<br />Segregation<br />· Segregate any dangerous goods that are incompatible to prevent them mixing. This may be<br />achieved by the use of an impervious barrier or by a separation distance sufficient to<br />prevent contamination (a distance of 1.5 metres should be sufficient in most<br />circumstances).<br />· Section 9.1.3 of the ADG Code provides advice on the compatibility of dangerous goods.25<br />Separation<br />You must provide separation of the dangerous goods from people or property at or beyond the<br />boundaries of the premises. For guidance on separation of dangerous goods, refer to section<br />18.5(e) on isolation.<br />Avoid sources of heat and ignition<br />· Keep ignition sources away from flammable or combustible dangerous goods (dangerous<br />25 Examples of dangerous goods which are incompatible and which should be segregated are:<br />- Class 5.1 oxidising agents from Class 2.1 flammable gases, Class 3 flammable liquids, C1<br />combustible liquids from Class 4.1 flammable solids (fire and explosion hazard);<br />- concentrated acids from alkalis (reaction hazard);<br />- cyanides from acids (generation of toxic gas hazard); and<br />- calcium hypochlorite from isocyanurate pool chlorine products (reaction and fire hazard).<br />71<br />goods class or subsidiary risk of 2.1, 3, 4.1, 4.2, 4.3 or combustible liquids). Naked flames<br />from direct fired heaters and any flames associated with maintenance work should be kept<br />at least 5 metres from the goods.<br />· Store dangerous goods away from sources of heat (for example, heating appliances).<br />· Where dangerous goods being stored or handled can generate flammable or explosive<br />atmospheres, use electrical equipment that is intrinsically safe or flameproof.<br />Spill control and clean-up<br />· Prevent any potential flow of dangerous goods to other parts of the premises that could<br />create a risk or reach any watercourse or the property boundary. Possible means are<br />bunding, provision of channels and utilising the slope of the land. Where spill containment<br />is required, it should have a sufficient capacity to contain the dangerous goods spillage.<br />· Keep equipment and materials for clean up at the premises to cope with spills from the<br />largest packages kept at the premises.<br />· Immediately clean up any spills and leaks. Contaminated, spilt or leaked goods should not<br />be returned to their original packaging except for the purposes of disposal or where it is<br />known that this will not increase the risk.<br />· Safely dispose of waste generated after the clean up of a spill or leak.<br />Decommissioning<br />· Ensure that any container or piece of equipment that has been used to store or handle<br />dangerous goods, and which is no longer required for that purpose, is cleaned free of<br />dangerous goods or otherwise made safe.<br />Ventilation<br />· Provide the areas in which dangerous goods are stored and handled with adequate natural<br />or mechanical ventilation sufficient to prevent the generation of a flammable or harmful<br />atmosphere. The level and type of ventilation will depend on the nature of the goods and<br />whether they are being stored or used. Ventilation is not required where the documented<br />assessment of the risks indicates that the likelihood of the release of flammable or harmful<br />dangerous goods into the atmosphere in the storage area is negligible.<br />· If you intend to rely on natural ventilation and need to install vents to achieve the<br />necessary airflow to maintain a safe atmosphere in the room being ventilated you should<br />consider the following:<br />- The need to provide vents at floor level and near the ceiling. Most dangerous goods<br />gases and vapours are heavier than air and will vent through the floor level vents. The<br />high level vents allowing fresh air to circulate into the room.<br />- The need to ventilate directly to the outside and not into another room.<br />- The need to provide a minimum amount of vent area and the spacing of vents to ensure<br />72<br />effective airflow. A useful guide is to allow at least 1 square meter of vent area for each<br />50 square meters of floor area. The actual amount of vent area and the number of vents<br />that should be provided will be dependent on the size of the room to be vented and<br />whether there are restrictions to the free circulation of the air within the room.<br />Lighting<br />· Provide sufficient lighting of areas where dangerous goods are stored and handled to allow<br />normal work to be undertaken safely.<br />Security<br />· Secure storage areas for dangerous goods against unauthorised entry.<br />Personal protective equipment<br />· Ensure PPE, appropriate to the goods being handled, is worn when people are handling<br />dangerous goods.<br />· Periodically check and maintain any PPE provided. Refer to Section 18.5 for additional<br />guidance.<br />Access and egress<br />· Don’t store dangerous goods where they could hinder escape from the building or area in<br />the event of a fire, spill or leak.<br />Fire prevention<br />· Keep areas in which dangerous goods are stored or handled clear of combustible matter<br />and refuse. In the case of storage or work outdoors, the surrounding area should be cleared<br />of combustible vegetation for a distance of at least 3 metres.<br />40. Fire protection<br />A supply of water should be available, at a nearby location for emergency use.<br />In addition to building fire protection, provide portable fire extinguishers appropriate to the<br />type and quantity of dangerous goods being stored and handled at or near to the place where<br />the dangerous goods are stored or handled.<br />Maintain all fire protection equipment in an operable condition.<br />41. Emergency procedures<br />Establish procedures for responding to all emergencies, taking account of:<br />- the nature and quantity of dangerous goods;<br />- the types and likelihood of emergencies;<br />- the fire protection and other emergency equipment provided;<br />73<br />- the physical features of the site;<br />- access to the premises; and<br />- the number of people on the premises and adjoining premises.<br />Ensure that all relevant emergency contact telephone numbers are displayed in a prominent<br />location at the premises.<br />42. Consultation, information and training<br />You have duties regarding consultation, information and training. Refer to section 14 and<br />section 28 for further guidance.<br />74shahzadhttp://www.blogger.com/profile/01364507074991292353noreply@blogger.comtag:blogger.com,1999:blog-7305327264533069235.post-40935837760727600882009-06-16T21:11:00.005-07:002009-06-19T21:47:33.745-07:00dangerous act 1985 RETAILERS DUTIESRETAILER’S DUTIES<br />29. Introduction<br />This Part of the Code provides guidance to occupiers who are retailers. It applies only to<br />dangerous goods in consumer packages that are:<br />· on display at retail outlets and are for sale to the general public; or<br />· kept in transit storage in areas of the retail outlet after they are unloaded from transport<br />vehicles and before they are displayed for sale.<br />It does not apply to dangerous goods in bulk containers that are stored and handled at retail<br />outlets.<br />What is a consumer package?<br />A “consumer package” means a container of a net capacity that is readily available through<br />retail outlets for household consumption or consumption by an occasional user. It is a package<br />that a manufacturer or supplier has identified as suitable for use in all market sectors.<br />The inner packaging quantities cited in table 1.1 and 1.2 of the ADG Code would all fall<br />within the commonly understood meaning of consumer package but do not restrict the<br />application of the term.<br />Examples of consumer packages are:<br />· “pool chemicals” such as granulated chlorine (class 5.1) – widely available in packages<br />having a net quantity of up to 10 kilograms;<br />· sodium hypochlorite solutions (class 8 PG II) – when marketed as a “pool chemical’ the<br />containers can have a capacity of up to 20 litres;<br />· ammonium nitrate fertilisers (class 9), which are widely available in a net quantity up to 25<br />kilograms.<br />30. Relationship with other Parts of this Code<br />If this Part of the Code applies to your premises, you may choose to follow the guidance in<br />this Part without the need to refer to Part 3 of this Code (except where noted).<br />31. MSDS<br />You are not required to obtain an MSDS for dangerous goods in consumer packages that are<br />intended for retail sale unless the consumer packages are opened on the premises. However,<br />you may choose to act by arrangement with your suppliers to distribute MSDS. This would be<br />particularly appropriate for trade sale outlets.<br />For those dangerous goods for which an MSDS has not been obtained, you must have<br />alternative relevant health and safety information readily accessible. This information may be<br />in the form of generic MSDS, health and safety information provided by the manufacturer or<br />supplier, and publications produced by industry organisations. It should enable employees and<br />65<br />emergency services authority personnel to deal with incidents such as spillages and damaged<br />consumer packages.<br />32. Risk management for retail situations<br />32.1 Hazard identification<br />It is sufficient compliance with regulation 404 for you to prepare a list of all of the types of<br />dangerous goods that are kept at the retail outlets. The list must include the name of each of<br />the dangerous goods, the Class, Subsidiary Risk and Packing Group of each of the dangerous<br />goods.<br />32.2 Risk assessment<br />It is sufficient compliance with regulation 405 for you to document the following broad types<br />of risks associated with the storage and handling of dangerous goods at the premises:<br />· fire and explosion risks associated with the storage and handling of flammable liquefied<br />gases (Class 2.1 or Subsidiary Risk 2.1), flammable liquids (Class 3 or Subsidiary Risk 3)<br />and dangerous goods of Class 4.1, 4.2 and 4.3 or Subsidiary Risk 4.1, 4.2 or 4.3.<br />· fire risks that may result from the storage and handling of oxidising agents of Class 5.1 or<br />Subsidiary Risk 5.1 or organic peroxides of Class 5.2.<br />· the toxic risks associated with dangerous goods of Class 6.1 or Subsidiary Risk 6.1.<br />· the corrosive risks associated with dangerous goods of Class 8 or Subsidiary Risk 8.<br />32.3 Risk control for goods on display<br />To control risk associated with dangerous goods in the display area:<br />· Ensure packages are marked in accordance with the ADG Code (unless the dangerous<br />goods are placed in a container provided by the purchaser).<br />· Keep dangerous goods away from other retail goods, such as food or personal products,<br />that could be contaminated in the event of leakage. This may be achieved by the use of an<br />impervious barrier or by a separation distance sufficient to prevent contamination (a<br />distance of 1.5 metres should be sufficient in most circumstances).<br />· Keep dangerous goods away from incompatible products. For example, swimming pools<br />chlorine (calcium hypochlorite) should be kept away from any oils, flammable and<br />combustible liquid. In addition isocyanurate pool chlorine and hypochlorite pool chemicals<br />can react violently together and must be kept separate. Section 9.1.3 of the ADG Code<br />provides advice on the compatibility of dangerous goods.<br />· Don’t store packages of liquid dangerous goods above solid dangerous goods in paper or<br />absorbent packaging.<br />· Stow packages in a way that will prevent the packages from falling or being dislodged and<br />being damaged.<br />· Do not open packages of dangerous goods on the premises. Exceptions to this would be for<br />66<br />tinting of paint for immediate sale and customer testing of the contents of the packages.<br />· If dangerous goods are dispensed into containers provided by the customer (for example,<br />mineral turpentine, kerosene or LP Gas), you should ensure that all aspects of the filling<br />operation comply with:<br />- AS 1940 The storage of flammable and combustible liquids if the dangerous goods are<br />flammable or combustible liquids;<br />- AS 1596 Storage and handling of LP Gas if the dangerous goods are LP Gas. (Refer to<br />section 11 of this Code for further guidance on filling gas cylinders.)<br />· Immediately clean up any spillage of dangerous goods in a safe manner.<br />· Ensure equipment and sufficient quantities of materials for absorbing, neutralising or<br />decontaminating spills from the largest packages on the premises are kept at the premises.<br />(Spill containment should not be needed unless the quantity of dangerous goods that may<br />spill on any one occasion could create a risk in other parts of the premises or beyond the<br />premises. Catchment for firefighting effluent is not required.)<br />· Keep ignition sources away from the areas where flammable or combustible dangerous<br />goods are kept. Naked flames from direct fired heaters and any flames associated with<br />maintenance work should be kept at least 5 metres from the goods.<br />· In addition to any fire protection measures provided for the premises as a retail outlet,<br />additional fire extinguishers suitable for use with the dangerous goods may be required.<br />You should seek advice from the emergency services authority.<br />32.4 Risk control in storages areas<br />If dangerous goods in consumer packages are kept in storage areas after being unloaded from<br />transport vehicles and before being moved to the display area, refer to the guidance in section<br />20.1 ‘Transit Storage’.<br />33. Placarding of the premises<br />Your premises must be placarded if the quantity of all dangerous goods at the premises<br />exceeds the “Placarding Quantity” in Schedule 2 to the Regulations. Refer to section 22 in<br />Part 3.<br />For packaged dangerous goods in display areas, it is sufficient to place placards at the entry<br />point into the building and area where the dangerous goods are being displayed.<br />34. Incidents and emergency management<br />You must establish a system for investigating every incident that occurs at the premises. Refer<br />to section 25 ‘Responding to an emergency’ for further guidance.<br />35. Consultation, information and training<br />You have duties regarding consultation, information and training. Refer to sections 14 and 28<br />in Part 3.<br />67<br />36. Keeping larger quantities of dangerous goods<br />If the quantity of dangerous goods at the premises exceeds the “Manifest Quantity” in<br />Schedule 2 of the Regulations, you must:<br />· prepare a manifest (refer to section 21.1);<br />· prepare a written emergency plan (refer to section 24.1); and<br />· notify WorkCover.shahzadhttp://www.blogger.com/profile/01364507074991292353noreply@blogger.comtag:blogger.com,1999:blog-7305327264533069235.post-63064096214493887672009-06-16T21:11:00.004-07:002009-06-19T21:45:08.386-07:00Overview of Risk Control Duties,Dangerous Goods Act1985Overview of Risk Control Duties<br />Control by:<br />substituting<br />other goods and<br />reducing<br />quantity<br />r.407<br />Design of new<br />premises, plant,<br />processes and<br />systems of work<br />r.410<br />Structures and<br />plant<br />r.418<br />Protection from<br />impact r.421<br />Transfer of<br />dangerous goods<br />r.423<br />Ventilation<br />r.425<br />26<br />18.4 Designing out risk<br />You must not use premises for the storage and handling of dangerous goods unless the<br />premises, plant, processes, systems of work and activities have been designed to eliminate<br />risks associated with storage and handling of dangerous goods, or, if this is not practicable,<br />reduce the risk so far as is practicable.<br />Design of the premises<br />Good design is the most effective tool you have to reduce risk. It means:<br />· reduced establishment costs;<br />· avoiding high operational costs caused by poorly set-out premises; and<br />· avoiding complex systems of work to cope with the constraints of poorly set-out premises.<br />An effective design process means that problems can be anticipated and solved before they<br />become real “bricks and mortar” problems.<br />Take account of any external factors in the layout of the premises, such as whether the<br />location and type of fire protection system meets with operational requirements of the<br />emergency services authority. If your premises has quantities of dangerous goods that exceed<br />the fire protection threshold and you intend to establish a fire protection system, you must<br />request the written advice of the emergency services authority in regard to the design of the<br />fire protection system, and have regard to that advice.<br />Designing a process with low risk<br />You must design out risk associated with a chemical or physical process by adopting the most<br />appropriate work method or system of work.<br />If a chemical process is involved, you may need to consider reaction pathways. Complexity,<br />equipment, efficiency, by products, cost, reliability and energy demand will influence the<br />selection of a particular reaction pathway. Where a physical process is involved, consider the<br />range of alternatives. For example, evaporation may be preferable to freeze drying, which<br />involves the reduction of temperatures and pressures.<br />You must identify the hazards and assess risks associated with each of the work processes<br />being considered. Select the process that eliminates the risk. If it is not practicable to do so,<br />adopt the process that most effectively reduces the risk.<br />Once a process has been selected, you must identify, assess and control any hazards that may<br />be associated with the use of dangerous goods in that process.<br />18.5 Categorisation of risk control measures<br />Regulations 407 and 410 combine to create, in effect, a three-step hierarchy. This is:<br />1. Elimination;<br />2. Control by substitution, engineering controls or isolation; and<br />3. Administrative controls or personal protective equipment<br />27<br />You must not rely solely on administrative controls or personal protective equipment unless it<br />is not practicable to control the risk by measures higher in the hierarchy.<br />(a) Elimination<br />The most effective method of risk reduction is the elimination of risks at the source. This<br />includes eliminating either the dangerous goods or the activity which gives rise to the risk. If<br />you store and handle dangerous goods and the dangerous goods are essential to the operation<br />of the premises (for example, where your principal business is contract storage of dangerous<br />goods) then elimination of all risks associated with the dangerous goods is not likely.<br />Examples of the elimination of dangerous goods include:<br />· use of a physical process rather than a chemical process to clean an object, such as the use<br />of ultra-sound, high pressure water or even steam cleaning rather than solvent washing;<br />· water based rather than solvent based paints or powder coating;<br />· clips, clamps, bolts or rivets instead of an adhesive;<br />· hot melt or water-based instead of solvent-based adhesives; and<br />· producing chlorine in-situ by electrolysis rather than having to store or handle other<br />dangerous goods which contain chlorine or one of its compounds.<br />Examples of eliminating an activity which gives rise to risk include:<br />· replacing a forklift (possible ignition and mechanical damage to the packages) to move<br />flammable packaged dangerous goods around with a system of conveyors. In this case an<br />activity that is dependent on the driver’s skill and care has been eliminated and replaced by<br />a handling method that does not depend on the skill and care of an operator.<br />· replacing the manual filling of a large open vat mixing and reacting flammable and toxic<br />dangerous goods (principal risks being fire, explosion, toxic release or spillage) with an<br />enclosed continuous process utilising “in the pipe” mixing and reaction (principal risk<br />spillage). In this case the activity of hand filling is eliminated but the process (chemical) is<br />not altered.<br />· wet mixing of a friction-sensitive dangerous goods powder instead of a hazardous dry<br />mixing process.<br />(b) Substitution<br />You must consider substituting the dangerous goods with other goods that have a lower risk<br />associated with their storage and handling, and reducing the quantity of dangerous goods<br />stored and handled. When considering whether to substitute dangerous goods with another<br />substance, you should ensure that the replacement substance does not create a different type<br />of risk. You also need to consider all the risks arising from the storage and handling of the<br />replacement substance to determine whether substitution is practicable.<br />Examples of substitution include:<br />· degreasing with a detergent instead of a chlorinated or volatile solvent;<br />· a combustible liquid such as diesel instead of petrol and kerosene which are Class 3<br />flammable liquids;<br />28<br />· a dangerous goods with a higher Packing Group number, for example, substituting xylene<br />(PGIII) for toluene (PGII);<br />· a less dangerous propellant in an aerosol, such as carbon dioxide Class 2.2 instead of unodorised<br />LPG of Class 2.1;<br />· dangerous goods without Subsidiary Risk; and<br />· using dangerous goods in a less dangerous form, such as a paste, pellets or a solution,<br />instead of a powder.<br />(c) Reducing quantities stored and handled<br />You must consider reducing the quantity of dangerous goods stored and handled. The<br />principle of reducing quantities of dangerous goods that are kept in storage is generally sound<br />but there a number of circumstances where the principle is not applicable. The most common<br />circumstances are where the premises is specifically designed to store dangerous goods –<br />either to contain the output from production at a manufacturer’s premises, or where the<br />occupier’s business is warehousing or contract storage. In some circumstances, the risk<br />assessment process may result in a risk control that determines a minimum quantity of<br />dangerous goods that must be maintained at the premises. For example, it may be necessary to<br />ensure that stock levels of a dangerous goods used as a stabiliser do not fall below a critical<br />level.<br />Ways to reduce quantity levels include:<br />· careful attention to inventory levels through effective stock control, such as the use of justin-<br />time ordering and supply arrangements;<br />· prompt disposal of dangerous goods no longer needed;<br />· selecting manufacturing and handling processes that are continuous rather than batch<br />processes;<br />· selecting chemical processes that have high conversion rates and result in less recycling or<br />stockpiling of raw materials; and<br />· using just-in-time in manufacturing areas (ie. only handling those dangerous goods that are<br />necessary for a production shift rather than stock piling the supply for several shifts in the<br />manufacturing area).<br />Care is necessary, however, to achieve the optimum inventory level. The optimum level that<br />may have been determined through cost control may not be the same as the optimum level<br />that should be achieved to reduce risk. For example the additional vehicle movements and the<br />increased handling associated with more frequent deliveries can create further risk.<br />(d) Engineering controls<br />Engineering controls are controls which use engineering measures to change the physical<br />characteristics of structures, plant, equipment and processes to reduce the risk associated with<br />the storage and handling of dangerous goods. They achieve this in a number of ways, by:<br />· minimising the generation of dangerous goods;<br />· containing or suppressing dangerous goods, including their vapours and dusts;<br />· eliminating, confining or controlling hazardous processes, plant or equipment that may<br />pose a risk to the dangerous goods;<br />29<br />· protecting dangerous goods and installations from external hazards and/or environmental<br />factors such as rain or sunshine; or<br />· limiting the area of contamination in the event of spills or leaks.<br />Engineering controls that should be considered include:<br />· totally or partially enclosing the dangerous goods or external hazard;<br />· providing adequate spill control to deal with the largest foreseeable spill (refer to section<br />19.6);<br />· specifying and installing appropriately rated electrical circuitry, fittings and equipment to<br />minimise ignition hazard (refer to section 19.8);<br />· providing adequate ventilation, including local exhaust ventilation, to eliminate flammable<br />or harmful atmospheres (refer to section 19.9);<br />· sparging or blanketing exposed liquid surfaces by an inert atmosphere to reduce<br />evaporation and prevent explosive atmosphere formation;<br />· automating processes to eliminate human exposure and error;<br />· fitting sensors and controls for liquid levels, pressure and/or temperature, to minimise loss<br />and formation of hazardous atmospheres, and eliminate overflow and uncontrolled<br />reactions;<br />· fitting safety critical control devices, alarms and critical condition shut-down devices;<br />· installing lighting which provides ample illumination for the tasks to be performed (refer to<br />section 19.10);<br />· installing fire detection systems and fire control systems (refer to section 23); and<br />· incorporating suitable protective devices to protect installations from external hazards,<br />such as crash barriers to protect from moving vehicles.<br />Appendix 7 provides further guidance on engineering controls for storage and handling sites.<br />(e) Isolation<br />Regulation 415 requires that you ensure the risk to people, property and other dangerous<br />goods at or beyond the boundaries of your premises is controlled by isolation.<br />Isolation is the separation of dangerous goods from people and other property, including other<br />dangerous goods. Physical separation is the principal method by which such risks are<br />controlled. Separation fulfils a dual purpose: protecting the other occupancies from the<br />dangerous goods; and protecting the dangerous goods from the other occupancies. Many<br />Australian Standards refer to “protected works” and define the expression it terms of different<br />types of occupancies, buildings or structures. All the various definitions for “protected works”<br />fall within the scope of property and do not limit it.<br />Distance, the use of effective barriers (such as fire rated walls or vapour barriers) or a<br />combination of both may achieve separation. The types of barriers used will be dependent on<br />the nature of the risks to be isolated.<br />Examples of isolation include:<br />· distancing the dangerous goods from people and other property;<br />· enclosing a hazardous activity, such as decanting in a fume cupboard where emissions can<br />30<br />be controlled by the use of scrubbers; and<br />· installing a vapour barrier with an appropriate fire resistance level (FRL)13 to provide<br />additional isolation.<br />Determining separation distances<br />Factors to consider include:<br />· the types of hazards exhibited by the dangerous goods and the risks they pose to the other<br />occupancy;<br />· the quantity of dangerous goods stored and handled in the work area;<br />· the type of installation and processes applied to the dangerous goods in the work area and<br />their associated hazards and risks;<br />· all other activities in the work area, which may increase the risk; and<br />· any control measures in place that will reduce the risk.<br />Minimum separation distances<br />For most classes of dangerous goods, minimum separation distances are specified in the class specific<br />Australian Standards listed in Appendix 3.<br />For example, AS 1940 includes a number of separate tables for bulk storages and package stores of flammable<br />and combustible liquids from boundaries, on-site facilities and specific facilities such as schools, hospitals,<br />ships and other workplaces. Distances vary depending on quantities, Packing Group (or C1 classification),<br />whether packages are opened or closed and, in one instance, tank diameter.<br />It should be noted, however, that AS 1940 has direct application only to storage and usage situations. It does<br />not apply to plant in which flammable or combustible liquids are processed, even though these often give rise<br />to increased risk. Similar limitations apply to most other Standards listed.<br />To determine if barriers – used in lieu of, or in conjunction with distances to achieve<br />separation – are effective with the particular dangerous goods, consider:<br />· the types of hazards exhibited by the dangerous goods and the risks they pose to the<br />barrier;<br />· the extent of vapour barrier required and its effectiveness in varied climatic conditions;<br />· appropriate levels of fire resistance (FRL) to be provided, depending on the potential heat<br />load from internal or external incidents; and<br />· structural strength necessary to withstand weather and any overpressure resulting from<br />internal or external incidents.<br />Most class specific Australian Standards listed in Appendix 3 provide for separation distances<br />to be measured around suitable barriers. They are referred to as vapour barriers, screen walls<br />and fire walls.14<br />13 Fire resistance level (FRL) gives a measure of the protection offered by a wall or structure when exposed<br />to fire, in terms of structural adequacy, integrity and insulation. The FRL rating system is defined in AS<br />1530.4. Further information about screen walls and vapour barriers may be found in AS 1940 and the<br />Building Code of Australia.<br />14 Further advice on the use of screen walls can be found in Australian/New Zealand Standard AS/NZS<br />3833 The Storage and Handling of Mixed Classes of Dangerous Goods in Packages and Intermediate<br />Bulk Containers. Australian Standard AS 1940 The Storage and Handling of Flammable and<br />31<br />Segregation of dangerous goods within a storage area<br />When held in the same storage area, dangerous goods should be segregated from other<br />dangerous goods or substances with which they are not compatible. Incompatible dangerous<br />goods – for example, Class 5.1 oxidising agents and flammable materials – should be stored<br />in separate buildings that are separated by sufficient distance so that an incident in one will<br />not involve the other.<br />Useful guidelines for segregation of incompatible dangerous goods is provided in<br />Australian/New Zealand Standard AS/NZS 3833 The storage and handling of mixed classes<br />of dangerous goods in packages and intermediate bulk containers.<br />Systems and procedures should be developed and enforced to ensure the segregation is<br />maintained at all times. Marking out those parts of the storage area where particular types of<br />dangerous goods are to be kept is one way of supporting those systems and procedures.<br />(f) Administrative controls<br />Administrative controls are systems of work or safe work practices that help to reduce risks<br />associated with the storage and handling of dangerous goods.<br />Examples of administrative controls include:<br />· safe work procedures that describe the correct methods for performing all activities<br />associated with the storing and handling of dangerous goods, for example:<br />- procedures for waste disposal and effective decontamination;<br />- procedures to ensure that work involving inspection, maintenance, repair, testing and<br />cleaning is carried out without risk;<br />· reducing the number of personnel in the dangerous goods work area (for example, the use<br />of internal work permits to restrict non-essential access);<br />· rotation of employees (with the appropriate skills) to limit the period of exposure for<br />individual employees;<br />· good housekeeping, including regular cleaning of work areas;<br />· prohibiting:<br />- eating, drinking, smoking and the carriage of matches and lighters in potentially<br />contaminated areas;<br />- the use of heat in a hazardous zone.<br />(g) Personal protective equipment<br />Personal protective equipment (PPE) includes full-length overalls, aprons, abrasion or<br />chemical-resistant gloves, dust masks, respirators or breathing apparatus, safety footwear or<br />chemical-resistant boots, goggles or face shields, hard hats, hearing protection and fully<br />encapsulated suits.<br />The use of PPE in conjunction with other control measures may provide additional risk<br />control. However, PPE relies heavily on users following instructions and procedures<br />correctly. As a result, you may need to provide a greater level of supervision than is required<br />Combustible Liquids uses the term fire wall for this purpose.<br />32<br />for other risk controls.<br />PPE may be necessary:<br />· where it is not practicable to achieve adequate control by other means;<br />· to safeguard safety and health until such time as adequate control is achieved by other<br />means, for example, where urgent action is required because of plant failure;<br />· during some infrequent maintenance operations where the short duration may make other<br />control measures impracticable;<br />· in an otherwise safe working environment, where protection may be required from acute<br />hazards in the event of sudden plant failure or other unexpected incident.<br />Selecting and maintaining PPE<br />MSDS will normally contain recommendations on the selection and use of personal protective<br />equipment for the particular dangerous goods. This advice should be followed unless the risk<br />assessment process determines that other PPE would be more appropriate.<br />When choosing the most appropriate PPE, ensure that:<br />· it provides the required level of protection from the risks associated with the particular<br />task;<br />· it is suitable for the individual’s size and build; and<br />· you consider the wearer’s need for mobility, dexterity, clear vision and communication.<br />You should ensure that people wearing PPE have been trained to fit and use it properly. Make<br />sure that the equipment is cleaned and maintained by appropriately trained staff in accordance<br />with relevant technical standards.15<br />18.6 Maintaining and reviewing risk controls<br />Once control measures are in place, you should check that they have been implemented<br />correctly and monitor their effectiveness. Control measures should be regularly reviewed.<br />Maintenance of control measures should include:<br />· frequent inspections;<br />· visual checks to ensure that controls are being properly applied;<br />· testing and preventive maintenance of engineering controls and PPE.<br />15 Further guidance on the selection, use and maintenance of personal protective equipment may be found in<br />the relevant referenced documents in Appendix 3.<br />33<br />19. Specific risk control duties<br />19.1 Stability of dangerous goods<br />Many dangerous goods are highly reactive, unstable or self-reactive except under controlled<br />conditions. The Regulations require that those controlled conditions be maintained.<br />Information about the required levels of stabilisers and/or control temperatures should be<br />provided by the supplier and included in the MSDS.<br />Where the stability of the dangerous goods is dependent on regular dosing with a stabiliser<br />you should ensure that there are sufficient stocks kept at the premises to take account of any<br />possible supply shortage.<br />If the dangerous goods must be stored at or below a control temperature that can only be<br />maintained by refrigeration, you should provide back-up refrigeration or develop a<br />contingency plan in the event there is loss of cooling.<br />19.2 Controlling risk associated with plant used at the premises<br />Plant used in the storage and handling of dangerous goods must be manufactured, installed,<br />commissioned, operated, maintained and repaired so as to control the risk associated with the<br />storage and handling of dangerous goods.16<br />Plant used to store and handle dangerous goods includes storage tanks, pipework, process<br />vessels, mixing vats, driers and filters.<br />To comply with this requirement, plant should be:<br />· manufactured to a high standard within the design specification, from quality, durable<br />materials which will not be adversely affected by the planned storage and handling of the<br />dangerous goods;<br />· installed only after all hazards associated with the installation have been identified, and the<br />risks assessed and controlled;<br />· commissioned only after it has undergone thorough testing and agreed procedures<br />developed to ensure it can be operated safely;<br />· operated only in accordance with the agreed procedures by personnel who have received<br />appropriate training;<br />· maintained and repaired to ensure that no additional hazards or increased risk arise due to<br />normal operation, wear and tear and breakdown; and<br />· maintained, repaired and, when the need arises, decommissioned in a manner which does<br />not introduce additional risks.<br />Maintenance or repair of plant may involve the use of ‘hot work’ processes that generate heat<br />or introduces ignition sources. In these circumstances you must control the risk of fire or<br />explosion involving the dangerous goods. A formal ‘hot work permit’ system is<br />16 The guidance in this section complements the specific duties and guidance that applies to plant covered<br />by the Occupational Health and Safety (Plant) Regulations 1995 and the approved Code of Practice for<br />Plant.<br />34<br />recommended. Some Australian Standards, such as AS 1940, provide detailed guidance on<br />‘hot work’ in areas where dangerous goods are stored and handled.<br />You must ensure that any pipework containing dangerous goods is marked so that the<br />dangerous goods are clearly identifiable, so far as is practicable. Suitable systems for<br />identification may be found in AS 1345 Rules for the Identification of Piping, Conduits and<br />Ducts and Australian Institute of Petroleum’s CP5 Code of Practice for Pipeline and<br />Underground Tank Identification.<br />Suitability of storage tanks<br />A storage tank constructed to AS 1692 Tanks for flammable and combustible liquids may be used to store<br />other classes of dangerous goods liquids like corrosive liquids and toxic liquids subject to a number of factors<br />including materials of construction and specific gravity. A tank designed and constructed for the storage of a<br />Class 3 flammable liquid like petrol may be suitable for diesel (C1 combustible liquid) or hydrochloric acid<br />(Class 8 dangerous goods). Any decision regarding the suitability of a tank must take into account the<br />chemical and physical characteristics of the dangerous goods, as well as structural considerations.<br />Plant and processes that are not used to store or handle dangerous goods, but have the<br />potential to interact with them, must not increase the risk associated with the storage and<br />handling of dangerous goods. Identify any hazards arising from such plant and processes. If<br />your risk assessment indicates there is a risk, control that risk using the methods outlined in<br />this section or by isolating the dangerous goods from the plant and processes.<br />19.3 Bulk containers for dangerous goods<br />A container and its pipework used for bulk storage needs to be:<br />· structurally sound and be capable of withstanding the stresses from the product being<br />stored;<br />· provided with stable foundations;<br />· resistant to corrosion over the service life of the container.<br />The bulk container must be inspected at sufficiently regular intervals to ensure that it remains<br />structurally sound. The results of the inspection must be recorded and retained for as long as<br />the container remains in service.<br />Specific design requirements for different types of bulk tanks and attachments including<br />pipework are included in several of the referenced documents in Appendix 3.<br />Underground tanks<br />Underground tanks pose risks and threats to people, property and the environment from:<br />· failure of the structure, usually due to corrosion, allowing the gradual escape of dangerous<br />goods into the water table; and<br />· spills from above-ground pipework and filling points.<br />Dangerous goods can migrate through the water table to present a risk to people and property<br />a long way from the tank. For example, flammable or toxic liquids and vapours can<br />accumulate in telecommunications pits or seep into building basements. Often the risks do not<br />35<br />become evident until there has been heavy rain that causes the water table to rise and displace<br />the dangerous goods that have accumulated in the soil around the tank.<br />There are many techniques available to monitor the integrity of underground tanks and detect<br />any leaks at an early stage. They include inventory monitoring, sampling pits, and a range of<br />electronic measures. Effective prevention is achieved by frequent monitoring. Protecting<br />underground tanks from corrosion often requires the assistance of specialists.<br />Guidance on underground tank installations for petroleum products can be found in Australian<br />Institute of Petroleum CP4 Code of Practice for Design, Installation and Operation of<br />Underground Petroleum Storage Systems. Care should be taken in applying this guidance to<br />dangerous goods other than petroleum.<br />19.4 Cleaning of decommissioned containers<br />Any receptacle that has contained dangerous goods must be cleared of the dangerous goods<br />before it is decommissioned or disposed of.17 Once you have done so, any residual risk<br />associated with the receptacle must be controlled.<br />Specific advice is contained in AS 1940, other Australian Standards and industry codes such<br />as the Australian Institute for Petroleum’s CP 22 The Removal and Disposal of Underground<br />Petroleum Storage Tanks.<br />If you are developing a procedure for decommissioning of receptacles, it should include:<br />· control of risks arising from any mechanical cutting, oxy-cutting, grinding or any other<br />activities involving heat or friction;<br />· how any was waste generated will be stored or disposed of; and<br />· safe entry into a receptacle which is a confined space.18<br />Used packagings that have not been made free from dangerous goods should retain labels and<br />markings that properly identify the residual hazard. When they are free of dangerous goods,<br />the labels or markings should be removed.<br />19.5 Protection from impact<br />You must ensure that dangerous goods and any structure and plant associated with their<br />storage and handling, are protected against damage from impact with vehicles, mobile plant<br />ships or boats. Mechanical handling equipment used for moving containers of dangerous<br />goods including forklifts or overhead lifting grabs can cause damage to containers either<br />directly through mishandling or indirectly by moving the containers into other objects – like<br />projecting pipework, railings or structures.<br />The most effective ways to protect containers, their pipework and attachments from this<br />impact is to locate the containers away from trafficable areas or prevent vehicle access. Where<br />17 Where plant is being disposed of the disposal may be subject to the requirements of the Environment<br />Protection Authority (EPA). The requirements of this regulation and the guidance in this Code are<br />intended to operate in addition to any requirements of the EPA.<br />18 For further guidance, refer to the Code of Practice for Confined Spaces.<br />36<br />vehicles must be able to come close to containers, the use of physical barriers like railings,<br />bollards or stanchions should be considered.<br />19.6 Spill containment<br />You must provide spill containment that will eliminate the risk or reduce risk so far as<br />practicable from any spill or leak of solid or liquid dangerous goods. This is required for<br />every area where dangerous goods are stored and handled. All spillages or leaks of dangerous<br />should be contained within the premises.<br />Factors that will determine the extent of spill containment include:<br />· the nature of the dangerous goods;<br />- if liquid, whether it is mobile or viscous;<br />- if solid, whether it will melt in a fire;<br />· the quantity of the dangerous goods;<br />· the size of the largest container or largest spill;<br />· the consequences of the spill; and<br />· whether or not it is necessary to provide for the management of firewater or other<br />extinguishing materials from an incident.<br />Spill containment for liquids may be achieved by:<br />· providing drains to a purpose built on-site catchment (for example, an interceptor or<br />remote impounding basin);<br />· grading the surface so that all spills are contained by the contours; or<br />· bunding the area to form a compound;19<br />· double walled containers;<br />· enclosing a tank with a partial or full height bund.<br />In some circumstances, it may not be necessary to provide any specific spill containment – for<br />example, if the dangerous goods are high melting point solids or highly viscous liquids (such<br />as some paints, resins and adhesives) in packages that are small in relation to the size of the<br />storage area.<br />Designing spill containment<br />You should ensure that:<br />· the spill containment system is impervious and can hold the dangerous goods until the spill<br />is cleaned up;<br />· the risks associated with the operation of the containment system are part of the design<br />consideration;<br />· the materials used in construction or for absorption are:<br />- compatible with the dangerous goods and other materials in the vicinity; and<br />19 A compound is an area bounded by natural ground contours or by a bund, being sufficiently impervious<br />to retain any spills or leaks of substances kept within the area pending the recovery of those spilled or<br />leaked substances.<br />37<br />- appropriate to avoid contamination of ground water or soil;<br />· the capacity of any compound is sufficient for the volume of liquid (including a margin for<br />fire water) to be contained;<br />· separate spill containment is provided where goods that are not compatible are kept within<br />the one storage area;<br />· absorbent materials, barriers and booms are provided where needed to contain a spill<br />outside areas where physical containment is provided or to assist in clean-up;<br />· contaminated firewater can be removed during an incident if needed; and<br />· means are available for removing any rainwater that may accumulate in the area.<br />If the design and location of your spill containment system may affect emergency services<br />operating procedures you should consult with the emergency services authority.20 For<br />example, the location of a remote impounding basin may limit the deployment of fire fighting<br />equipment.<br />A number of documents referenced in Appendix 3 provide specific guidance on spill<br />containment.<br />19.7 Transfer of dangerous goods<br />Transfer of dangerous goods refers to the movement of the dangerous goods:<br />· from place to place within premises; and<br />· into or from a container.<br />It generally poses far greater risk than static storage. The goods will often be unconfined at<br />some stage of the transfer process such as when pouring or pumping from one container to<br />another. Additional hazards include:<br />· increased vapour levels around the operation;<br />· generation of static electricity;<br />· overflow or spillage; and<br />· spillage away from spill containment installations, such as where the transfer is by<br />pipeline.<br />The transfer system should take into account:<br />· hazards associated with the particular dangerous goods;<br />· required flow or transfer rates and quantities; and<br />· external hazards and adjacent activities.<br />If dangerous goods are transferred into a portable container for use at the premises, you must<br />ensure the container is marked with the Class label, Subsidiary Risk label and the product<br />name of the dangerous goods, or, if this is not possible, by some other means of clearly<br />identifying the dangerous goods. This is not required if the transferred dangerous goods are<br />consumed immediately and the container is cleaned free of dangerous goods.<br />20 The Regulations define “emergency services authority” as the Metropolitan Fire and Emergency Services<br />Board or the Country Fire Authority.<br />38<br />The ADG Code and several of the documents referenced in Appendix 3 provide specific<br />requirements for certain dangerous goods transfers.<br />19.8 Controlling ignition sources in hazardous areas<br />You must ensure that ignition sources are not present, so far as is practicable, in any<br />hazardous area where dangerous goods are stored or handled.<br />What are ‘hazardous areas’?<br />Flammable or combustible gases, vapours, dusts and mists may be generated or evolve within<br />a dangerous goods storage and handling environment. These can form explosive mixtures<br />with air in certain proportions. This risk is particularly relevant with dangerous goods of Class<br />2.1, 3 and 4 or dangerous goods with a Subsidiary Risk of 2.1, 3 or 4. However, other Classes<br />of dangerous goods may also contribute to explosive atmospheres under some circumstances.<br />The classification of ammonia does not indicate a flammable Subsidiary Risk because its<br />explosive limits are within a very narrow range.<br />An area where an explosive atmosphere may occur is described as a ‘hazardous area’. AS<br />2430 designates different levels of hazardous areas. That standard also describes the extent of<br />the hazardous area for many specific situations.<br />The extent of the hazardous area needs to be determined for all areas where the following<br />dangerous goods are stored or handled:<br />· Class 2.1, 3, 4 or 5 dangerous goods;<br />· dangerous goods with a Subsidiary Risk of 2.1, 3, 4 or 5; or<br />· goods which may generate combustible dusts.<br />The identification of hazardous areas should be undertaken by people having a thorough<br />knowledge of the storage and handling areas at the premises and the activities that involve the<br />dangerous goods.<br />Ignition sources<br />An ignition source is any source of energy sufficient to ignite a flammable atmosphere.<br />Ignition sources include:<br />· naked flames, including those from blow torches, shrink wrapping equipment, stoves, gas<br />or oil heaters, pilot lights, driers, cigarettes, lighters and matches;<br />· static electricity (see below);<br />· heat from appliances or from chemical or biological reaction vessels;<br />· friction from moving parts, such as fan blades rubbing nearby surfaces;<br />· sparks from grinding and welding;<br />· internal combustion engines and vehicles;<br />· electric equipment, such as power points, switches, lighting, appliances and batterypowered<br />forklift trucks, which is not rated for the hazardous area; and<br />· radio transmitters and mobile phones.<br />39<br />Controlling ignitions sources – electrical equipment within hazardous areas<br />The ignition potential of electrical equipment located within a hazardous area can be<br />controlled by providing wiring, switching and equipment protection that is suitable for use in<br />the area. Guidance on electrical protection systems can be found in AS 1482 Electrical<br />equipment for explosive atmospheres – Protection by ventilation, and a number of other<br />documents listed in Appendix 3.<br />When you provide additional mechanical ventilation to reduce the extent of the hazardous<br />zone, you should also control any risks that would arise if the ventilation failed. One such<br />method would be the complete interlocked shutdown of all electrical systems within the room<br />or building.<br />Restrictions on possession of potential ignition sources<br />You should have a procedure to ensure that people do not take any substance or article with<br />the potential to be an ignition source within 3 m of a hazardous area.<br />Where a naked flame or ignition source is required in an operation adjacent to a hazardous<br />area, a formal ‘hot work permit’ system is recommended. Some Australian Standards, such as<br />AS 1940, provide detailed guidance on ‘hot work’ in areas where dangerous goods are stored<br />and handled.<br />Generation of static electricity<br />Static electricity may be generated by:<br />· movement (pouring, pumping, stirring and high velocity flow) of the dangerous goods or<br />combustible liquids, particularly dry powders and liquids of low electrical conductivity;<br />· dry air streams;<br />· movements of personnel, especially when wearing, donning or removing clothing and<br />footwear of low conductivity. (Some protective clothing – for example, those made of<br />synthetic fibres like polyester – may not be static resistant and care should be taken during<br />its selection);<br />· application and removal of plastic wrap;<br />· particulate or aerosol spray, including spray painting or the rapid discharge of a carbon<br />dioxide extinguisher; and<br />· moving plant.<br />Avoidance of static<br />To guard against static electricity discharge:<br />· all tanks, pipework, transfer systems and process plant associated with the storage and<br />handling system should be earthed, or otherwise protected, in accordance with AS 1020;<br />and<br />· use anti-static additives in non-conductive liquids and the wearing of conductive clothing,<br />especially footwear.<br />40<br />Controlling ignition sources outside hazardous areas<br />All other ignition sources on premises where dangerous goods are stored and handled should be identified and<br />the sources eliminated or controls put in place where there is any likelihood that those ignition sources could<br />result in an incident. An example of a situation where an ignition source outside the hazardous area should be<br />eliminated is a gas fired furnace that is located in the likely path that flammable vapour that would follow in<br />the event of a spill of flammable liquid. Flammable liquid vapours are heavier than air and tend to flow by<br />gravity along natural channels and drains quite long distances before dispersing.<br />19.9 Ventilation<br />You must ensure that the risk associated with flammable, explosive or asphyxiant<br />atmospheric conditions is controlled.<br />The purpose of ventilation is to produce and maintain a safe working atmosphere in the<br />storage and handling area. Ventilation is achieved by the introduction or recirculation of air<br />by natural, forced or mechanical means.<br />Safe atmosphere<br />A safe working atmosphere is one in which:<br />· there is a safe oxygen level for breathing;<br />· hazardous gases, vapours, mists, fumes and dusts are within relevant exposure standards;<br />· the concentration of flammable gases, vapours, mists, fumes and dusts is always below 5<br />per cent of the lower explosion limit; and<br />· the build-up of heat and extremes of temperature is avoided.<br />To ensure a safe atmosphere is maintained, atmospheric testing and monitoring may need to<br />be carried out consistent with the hazards identified and the risk assessment.<br />Design considerations<br />A ventilation system for the storage and handling area should be exclusive to the particular<br />building, room or space. Where this is not achievable, the system may be linked to another<br />area provided that there will not be an increased risk arising from incompatible goods or any<br />other relevant hazard.<br />Local exhaust ventilation removes airborne contaminants from the working environment<br />before they reach the breathing zone of personnel in the area. It is usually more effective than<br />an increase in general ventilation. General or dilution ventilation has limitations and should<br />only be considered for contaminants of low toxicity. In addition, the quantity of contaminants<br />generated should be relatively small, otherwise it would not be practicable to achieve the air<br />volumes required for dilution.<br />Ventilation systems should be suitable for the types of dangerous goods on the premises. For<br />instance, where there are dangerous goods with vapours heavier than air, fumes should be<br />removed from the lowest point above any spill containment and fresh air introduced from<br />above.<br />41<br />Fresh air should be drawn from a source uncontaminated by exhaust air or other pollutants<br />and the exhaust discharged where it will not cause other risks, in compliance with<br />environmental legislation concerning discharges to atmosphere.<br />Ventilation by recirculated air should be restricted to areas where temperature control is<br />required.<br />Most of the Australian Standards covering individual and mixed class storage and handling<br />and some of the other documents referenced in Appendix 3 provide detailed instructions on<br />the provision of ventilation.<br />Purging<br />Purging is the method by which any contaminant is displaced from a confined space. The<br />confined space may be purged, for example with an inert gas such as nitrogen, to clear<br />flammable gases or vapours before work in the confined space.<br />After purging with inert gases the confined space should be adequately ventilated, and retested.<br />The purging of a space should be undertaken in a manner that will not cause rupture or<br />collapse of the enclosure due to pressure differentials, and the methods employed should<br />ensure that any contaminant removed from the confined space is exhausted to a location<br />where it presents no hazard.<br />Displacement of contaminated air may be temporary. For example, flammable gases absorbed<br />into the walls of a steel tank may leach out and recreate the flammable atmosphere. Where<br />flammable contaminants may build up in the confined space, you should consider whether it<br />would be necessary to re-purge the space. Because purging may reduce oxygen levels or there<br />may be residual contamination, safe entry procedures should be developed and enforced.<br />These may require atmospheric sampling and monitoring or the use of breathing protection.<br />You should refer to the Occupational Health and Safety (Confined Spaces) Regulations 1996<br />in respect of entry to confined spaces. Note that the Confined Spaces Regulations prohibit<br />pure oxygen or gas mixtures with oxygen in concentration greater than 21 per cent by volume<br />being used for purging or ventilating a confined space because of the risk of increased<br />flammability.<br />19.10 Additional risk control measures for your premises<br />Introduction<br />To ensure that you are providing a working environment that is safe and without risks to<br />health, you should consider these additional controls.<br />Lighting<br />You should ensure that:<br />· adequate natural or artificial lighting is provided to all areas where dangerous goods are<br />stored or handled, and access ways;<br />· the only artificial lighting used in a room or space where dangerous goods are stored or<br />42<br />handled is electric lighting;<br />· electric lighting used in a hazardous area meets the provisions of AS 3000;<br />· internal lighting meets the relevant provisions of AS 1680; and<br />· emergency exit lighting is provided, if necessary.<br />Access and egress<br />Access to the premises<br />Ensure access to the premises and all work areas by having:<br />· routes kept clear at all times;<br />· external access routes kept clear for vehicular access, including emergency vehicles; and<br />· doors and gates unlocked when they may be required as exit points; and<br />· outward-opening doors, where appropriate. 21<br />Access should be readily available to the emergency services authority personnel.<br />Access to safety equipment<br />Clear access should be provided at all times to equipment used to contain and clean up<br />incidents and firefighting equipment.<br />Provision of safety signs<br />You should provide safety signs that are readily recognisable, understandable and durable. AS<br />1319 Safety signs for the occupational environment provides examples of safety signs which<br />may be applicable.<br />Many Australian Standards and industry codes of practice provide specific advice on safety<br />signs that should be displayed in certain circumstances. For example AS/NZS 1596Storage<br />and handling of LP Gas contains specific advice on safety signs to be displayed at an<br />automotive dispensing installation.<br />Safety signs should be:<br />· in formats (written or pictorial) that take into account the cultural diversity of the intended<br />audience;<br />· visible against background structures; and<br />· easily interpreted in the conditions that may prevail, such as low light.<br />21 The Building Code of Australia stipulates that required exit doors must open outwards, with an opening<br />device that opens with a single action.<br />43<br />Types of Signs Examples<br />Regulatory signs<br />WARNING – RESTRICTED AREA<br />AUTHORISED PERSONNEL ONLY<br />SELF SERVE NOT PERMITTED<br />Hazard warning signs<br />FLAMMABLE GAS<br />Precautionary signs<br />HIGH PRESSURE OUTLET<br />NO SMOKING – STOP ENGINE<br />ATTACH EARTH CLIP BEFORE<br />PUMPING<br />Emergency information signs<br />EMERGENCY STOP BUTTON<br />Figure 5: Examples of common types of safety signs<br />20. Controlling risk at specialised facilities and operations<br />20.1 Transit storage<br />The term transit storage refers to short term storage at a location where dangerous goods are<br />held while they are awaiting:<br />· loading for dispatch after their removal from storage areas;<br />· being placed in storage after receipt and unloading; or<br />· transfer within a premises for a specific purpose such as manufacturing.<br />Port areas are facilities where the transit storage of dangerous goods would comprise the<br />major proportion of the storage and handling activities at the premises. AS 3846 The handling<br />and transport of dangerous cargoes in port areas provides advice for port areas.<br />Transit storage locations can present a particular risk as they interface between transport and<br />storage activities and they may contain dangerous goods with widely varying hazards.<br />The quantities of dangerous goods in a transit storage location and the duration of that storage<br />should be kept to a minimum commensurate with efficient operation but must not be kept at<br />the premises for more than 5 consecutive days.<br />44<br />You should ensure that an incident occurring in a transit storage location is not likely to<br />adversely affect the permanent storage or process areas or any other operations. Therefore,<br />transit storage locations should be provided with controls appropriate to the type and quantity<br />of goods stored, including:<br />· appropriate segregation of the dangerous goods in the area;<br />· equipment for containment and clean-up of spills and leakages and emergency response;<br />and<br />· PPE for personnel in the area.<br />20.2 Transport storage areas<br />‘Transport storage areas’ are areas at premises where dangerous goods in transit may be<br />stored while awaiting further transport. They may also be areas where dangerous goods that<br />have been kept in permanent storage areas are assembled into transport loads and kept there<br />while awaiting dispatch. Transport storage areas are also areas that provide for the short term<br />handling of dangerous goods either prior to transport or prior to relocation into more<br />permanent storage within a premises. They include:<br />· locations inside a building (for example, at a transport depot) where packages or<br />intermediate bulk containers are held awaiting loading;<br />· external areas where loaded freight or tank containers are held awaiting further transport;<br />and<br />· areas where loaded vehicles – including trailers and rail wagons – are held in transit.<br />Types of premises that would make provision for transport storage areas would include ports,<br />rail yards and road transport depots.<br />Transport storage areas are not intended to substitute for more permanent storages of<br />dangerous goods. The quantity of dangerous goods stored in such areas should be minimised<br />to the quantity necessary to receive or dispatch dangerous goods in an efficient manner.<br />Control measures for transport storage areas<br />Ensure that:<br />· the length of time that dangerous goods are held does not exceed five consecutive working<br />days;<br />· all dangerous goods that are assembled in loads ready for transport are packaged or<br />contained, marked, stowed, secured, placarded, segregated and documented according to<br />the ADG Code;<br />· incompatible dangerous goods are segregated according to particular transport mode in the<br />ADG Code;<br />· dangerous goods are kept apart from foodstuffs (including stock feed), so as to avoid any<br />potential contamination;<br />· ignition sources are controlled;<br />· provision is made for dealing with spills; and<br />· appropriate fire protection is provided.<br />45<br />Placarding for transport storage areas<br />Transport storage areas often encounter regular variation in the types of dangerous goods<br />held. It may be more convenient to use frames for slip-in/slip-out labels that are commonly<br />used on vehicles for the transport of dangerous goods.<br />20.3 Cylinders for gases<br />Where Class 2 dangerous goods are stored and handled in cylinders, you should comply with<br />the relevant parts of AS 4332 The storage and handling of gases in cylinders.<br />In addition to the provisions of AS 4332, you should ensure that:<br />· any cap provided for use with the cylinder is kept in place on the cylinder at all times when<br />the cylinder is not connected for use; and<br />· unless the container is connected by permanent piping to a consuming device, the valve of<br />the container is kept securely closed at all times.<br />Appendix 6 provides further guidance on storing and handling particular dangerous goods.<br />21. Preparing a manifest and plan of the premises<br />21.1 Manifest<br />You must ensure that a manifest is prepared when the quantity of dangerous goods exceeds<br />the quantities listed in the “Manifest Quantity” column in Schedule 2 of the Regulations.<br />The principal purpose of the manifest is to provide the emergency services authority with<br />information on the quantity, type and location of dangerous goods stored and handled on the<br />premises, to enable them to respond appropriately if called to an incident.<br />The manifest must be kept on the premises in a place that is easily accessible to the<br />emergency services authority. It should be located near the Outer Warning Placard at the front<br />of the premises, unless otherwise agreed with the emergency services authority. It should be<br />housed in a holder of substantial weatherproof construction.<br />The manifest must include the following information:<br />(i) the name of the occupier of the premises;<br />(ii) the address of the premises;<br />(iii) the date when the manifest was prepared or last amended;<br />(iv) contact information for at least 2 people who may be contacted in the event of an<br />incident;<br />(v) a summary list of the Classes and Packing Groups (if any) of the dangerous goods at the<br />premises;<br />(vi) information about dangerous goods stored in bulk in other than IBCs;<br />(vii) information about packaged dangerous goods in IBCs;<br />(viii) information about dangerous goods in manufacture;<br />(ix) dangerous goods in transit; and<br />(x) a plan of the premises.<br />46<br />The manifest must be revised when there is a change in any of the above information.<br />Dangerous goods in transit<br />If the dangerous goods are in transit, and there are dangerous goods shipping documents that<br />comply with the ADG Code available for the goods, the information required by items (v),<br />(vi) and (vii) above may be provided in the form of a compilation of those shipping<br />documents. However, MSDS should be used if they are available.<br />A sample manifest is provided at Appendix 8 of this Code of Practice.<br />21.2 Plan of the premises<br />The purpose of the plan of the premises is to identify the places, buildings and structures on<br />the site where dangerous goods are stored and handled. It should be easy for emergency<br />services authority personnel to read.<br />The plan of the premises should be on a scale that adequately illustrates the details required<br />by the Regulations. The following information is required:<br />· locations and identification number or code of:<br />- bulk containers and bulk storages; and<br />- storage areas for packaged dangerous goods and dangerous goods in IBCs; and<br />- areas where dangerous goods are manufactured; and<br />- areas where dangerous goods in transit may be located<br />· legend for the identification numbers and codes for the above areas; and<br />· main entrance and other entry points to the premises; and<br />· location of essential site services including fire services and isolation points for fuel and<br />power; and<br />· location of the manifest for the premises; and<br />· location of all drains on the site; and<br />· nature of the occupancy on adjoining sites or premises.<br />In addition, the following information may be relevant:<br />· the location of all buildings, amenities, structures and internal roadways on the premises<br />and their uses;<br />· areas of public access adjacent to the site and parking (if any);<br />· public street names adjacent to the premises and evacuation routes; and<br />· nature of fences (if any).<br />A sample plan is found at Figure 7.<br />47<br />Car Repair Shop<br />Office<br />and<br />Amenities<br />Entry<br />Emergency<br />Gate<br />Garage<br />and<br />Workshop<br />Main<br />Gate<br />Package<br />Store<br />PS2<br />Class<br />6.1<br />PS3<br />Class 3<br />PS4<br />Class 8<br />Power<br />Isolation<br />Manifest<br />DGT1<br />DGT3<br />Empty<br />Pallets<br />DGT4<br />PS1<br />Class 4.1<br />Fire<br />Hydrant<br />Fire<br />Hydrant<br />Drain<br />Intercept<br />Stormwater Grates<br />MA3<br />Class 3 & 8<br />MA1<br />Class 3<br />MA2<br />Class 5.1<br />Sub Risk 8<br />Factory<br />Boundary -Chain Wire Fence<br />Boundary -Chain Wire Fence Vacant Land<br />Boundary -Furniture Factory<br />Francis Street<br />North<br />Emergency<br />Gate<br />Car<br />Park<br />DGT2<br />Scale 0 10 20 30 40 50 metres<br />Figure 7: Sample plan of a premises<br />48<br />22. Placarding<br />Placards provide visual warning of the hazards associated with the dangerous goods at the<br />premises. You must ensure that your premises are placarded if dangerous goods are stored in<br />bulk or in a quantity that exceeds the quantity specified in the column headed “Placarding<br />Quantity” in Schedule 2 of the Regulations, unless they:<br />· are in an IBC or bulk container intended for transport and marked in accordance with the<br />ADG Code; or<br />· are C1 combustible liquids in a quantity not exceeding 10,000 litres; or<br />· are dangerous goods of Class 2.1 or 3 or C1 combustible liquids and are stored in an<br />underground tank at a retail outlet where the goods are used to refuel vehicles.<br />Placards that were provided to comply with the Dangerous Goods (Storage and Handling)<br />Regulations 1989 may continue to be used until such time as they have become illegible or<br />need to be replaced. Replacement placards must comply fully with the new Regulations.<br />Placards must be kept legible and unobstructed.<br />Types of placards<br />(a) Placards for bulk dangerous goods<br />Placards for bulk storage of dangerous goods are essentially the same as the full size<br />Emergency Information Panel required by the ADG Code for bulk transport, with the<br />emergency contact details removed.<br />The placard must be located on or adjacent to the bulk storage, unless otherwise agreed in<br />writing by the emergency services authority.<br />50 50<br />AMMONIA,<br />ANHYDROUS<br />100<br />UN No.1005<br />100<br />HAZCHEM 2RE 2<br />TOXIC<br />GAS<br />CORROSIVE<br />Figure 8: Sample of a placard for bulk dangerous goods<br />49<br />Dangerous goods<br />and/or<br />C1 combustible<br />liquids in bulk<br />other than IBCs<br />Yes<br />Yes<br />Are dangerous goods<br />or C1combustible<br />liquids:<br />· Class 2.1 or 3 in<br />underground<br />tanks at a service<br />station?<br />· in portable bulk<br />containers<br />marked for<br />transport?<br />No<br />No<br />Placard for<br />dangerous goods<br />in bulk required<br />as per<br />Schedule 4 of the<br />Regulations<br />Yes<br />Bulk placarding not<br />required<br />Figure 9: Flow diagram – placarding requirements for dangerous goods in bulk<br />(b) Placards for packaged dangerous goods<br />Storage and handling areas for packaged dangerous goods must be placarded if the quantity in<br />the area exceeds the quantity specified in the column headed “Placarding Quantity” in<br />Schedule 2.<br />Figure 10: Sample of a placard for a dangerous goods stored in packages<br />The class and/or mixed class labels required by the Regulations should be grouped together.<br />The class labels need not, however be placed in the one horizontal line on a shared sign as<br />illustrated in Schedule 4 of the Regulations, provided they are clearly visible against a<br />contrasting background. Vertical or diagonal grouping is equally acceptable.<br />100 mm<br />50<br />For those storage and handling areas where there is regular variation in the types of dangerous<br />goods (for example, in transit storage locations and transport storage areas), it may be more<br />convenient to use frames for slip-in/slip-out labels that are commonly used on vehicles for the<br />transport of dangerous goods.<br />(c) Outer warning placards<br />A ‘HAZCHEM’ Outer Warning Placard is required if the quantity of dangerous goods stored<br />or handled at the premises exceeds the “Placarding Quantity” in Schedule 2.<br />Outer Warning Placards must be displayed at all road and rail entrances to the premises. For<br />schools and farms, placards must be displayed at the main road entrance.<br />If the premises consist of a building set back from the street such that placarding at the street<br />entrance would be neither effective nor practical, Outer Warning Placards should be displayed<br />at each entrance to the building that may be used by the emergency services. However, you<br />must have the written agreement of the emergency services authority to do so.<br />120 mm HAZCHEM 100 mm<br />lettering<br />L<br />Figure 11: Form and dimensions of an Outer Warning Placard<br />Aggregate quantity of<br />dangerous goods exceeds<br />Schedule 2 “Placarding<br />Quantity”<br />Yes<br />No<br />Quantity of<br />C1 combustible liquid<br />at premises where no<br />dangerous goods are stored and<br />handled exceeds<br />· 10,000 L in bulk; or<br />· 50,000 L in packages<br />Yes<br />HAZCHEM<br />outer warning<br />placard<br />required<br />Figure 12: Flow diagram – requirement for outer placarding<br />51<br />23. Fire Protection<br />You must ensure that the premises are provided with fire protection and fire fighting<br />equipment that:<br />· is designed and constructed for the types and quantities of dangerous goods and the<br />conditions under which they are stored and handled; and<br />· uses fighting media that are compatible with the dangerous goods and effective in the<br />control of incidents involving the types and quantities of dangerous goods.<br />23.1 Fire protection systems<br />While the Building Code of Australia specifies minimum requirements for fire protection,<br />additional fire protection will usually be required for premises where dangerous goods are<br />stored and handled.<br />The design and construction of the fire protection for each area in which dangerous goods are<br />stored and handled and for the premises as a whole, should take account of the relevant<br />Australian Standards and industry codes of practice listed in Appendix 3.<br />Premises exceeding the “fire protection threshold”<br />If a quantity of dangerous goods held at your premises exceeds that specified in the column<br />headed “Fire Protection Quantity” in Schedule 2, and you intend to establish a fire protection<br />system, you must request the written advice of the emergency services authority in relation to<br />the design of the system. You must have regard to that written advice when establishing the<br />system.<br />You are also required to request the written advice of the emergency services authority in<br />relation to the design of the system, and have regard to that written advice if you intend to<br />make modifications to:<br />· the buildings or structures on the premises; or<br />· the types or quantities of dangerous goods stored or handled at the premises; or<br />· plant or processes associated with the storage or handling of dangerous goods on the<br />premises; or<br />· the fire protection system.<br />Designing the fire protection system<br />Fire protection system design should take account of:<br />· the chemical and physical properties of the dangerous goods;<br />· the total fire load of the area being protected;<br />· particular hazards of the dangerous goods and the quantities being stored and handled;<br />· the location, design, type of construction and total floor area of the building or storage and<br />handling area;<br />· the type of operations in the building or storage and handling area, with particular attention<br />to the:<br />52<br />- extent of the containment of dangerous goods provided;<br />- how the dangerous goods are stored and handled (chemical and physical processes and<br />transport systems); and<br />- storage configuration, height and density;<br />· the impact of hazards external to the storage and handling area, including beyond the<br />boundaries of the premises;<br />· the personnel available to operate the system and their capability;<br />· the need to protect external facilities;<br />· all relevant environmental considerations; and<br />· the need for the fire protection system to remain in operational condition itself in the event<br />of a fire.<br />Compatibility of the fire protection system with dangerous goods<br />Fire fighting media (such as water, foam or dry agent) must be compatible with the dangerous<br />goods. For example, sprinklers and water based extinguishers should not be used with<br />dangerous goods of Class 4.3 – Dangerous When Wet.<br />Water supply<br />The water supply should be sufficient to supply both the fire protection equipment at the<br />premises and any additional equipment used to control a fire at the premises by the emergency<br />services authority.<br />Where sufficient supply is not available from the main water supply, it may be necessary to<br />supplement this with additional water storage and/or pumps or, where permitted by the<br />appropriate regulatory authorities, by drawing fire service water from alternative sources such<br />as rivers or dams.22<br />The adequacy of the water supply should be checked with the emergency services authority.<br />Specific guidance is provided in AS 1940 and AS 2419.<br />Booster systems may need to be installed to provide sufficient pressure for large-scale<br />firefighting. This may require:<br />· installation of fixed or portable pumping equipment; or<br />· an appropriate number of booster connections and feed hydrants, together with an<br />approved hard standing area for emergency services authority pumping equipment.<br />Fire alarm systems<br />Fire alarm systems should be designed in accordance with AS 1670 and AS 1603.5, and<br />installed so that:<br />· automatic systems are also capable of being manually activated at clearly identified manual<br />alarm call points at convenient and safe locations near work areas;<br />22 If other than town water is used as a fire water supply, the cleanliness and the corrosive properties of the<br />water need to be taken into account. A dirty or corrosive water supply may block or damage pumping<br />equipment, distribution pipework, nozzles and sprinkler heads.<br />53<br />· the alarm signal is sufficiently distinguishable from any other signals to permit ready<br />recognition, and clearly audible throughout the storage installation;<br />· where high noise levels or the use of protective clothing may prevent the recognition of an<br />alarm signal, an effective alternative alarm system is also installed, such as a visual system;<br />and<br />· the system remains operable when the main power supply fails.<br />Alarm systems for larger dangerous goods storage and handling installations should be<br />directly linked to the emergency services authority.<br />23.2 Fire fighting equipment<br />All fire protection and detection equipment should comply with the appropriate Australian<br />Standards listed in Appendix 3.<br />Compatibility with equipment used by the emergency services authority<br />Fire fighting equipment at the premises must be capable of being used, without adaptation or<br />modification, with the equipment used by the emergency service authority. Ensure that:<br />· the pressure rating of fire mains and associated equipment is consistent with the pressures<br />that may be imposed by the connection of the emergency services authority's equipment;<br />· fire fighting foam or any special fire protection medium, if used, is compatible with the fire<br />fighting media used by the emergency services authority.<br />The design and selection of coupling and the selection of fire fighting media should be carried<br />out in consultation with the emergency services authority.<br />Location of firefighting equipment<br />Firefighting equipment should be located so that:<br />· all dangerous goods and other items being protected can be directly reached by the<br />firefighting medium, with particular attention to high rack storage;<br />· it is readily accessible in the event of an incident, preferably adjacent to exit doors or on<br />exit routes; and<br />· it is in a conspicuous position.<br />Identification of firefighting equipment<br />All firefighting equipment should be suitably labelled in accordance with the relevant<br />Australian Standards.<br />Where necessary to assist with the identification of firefighting equipment, additional signs<br />complying with AS 1319 Safety signs for the occupational environment should be installed.<br />54<br />Requirements for specific equipment<br />(a) Fire hose reels<br />Fire hose reels should comply with AS 1221 and be installed to AS 2441, the requirements of<br />the relevant emergency services authority and the Building Code of Australia.<br />Hose reel systems should be located:<br />· as required by the relevant emergency services authority;<br />· on every storey of a building used to store and handle dangerous goods where the total<br />floor area exceeds 300 m2;<br />· so that every location in the building can be reached by at least one hose, allowing for all<br />obstacles; and<br />· so that it is possible to reach all installations, including to the top of rack storage.<br />Hose reels should be provided with:<br />· a minimum hose length of 36 m;<br />· conspicuous signage; and<br />· protection by a cabinet or other suitable means, if the hose reel is installed in an<br />environment where it may be damaged.<br />Where foam hose reels are installed, they should be capable of producing foam to the<br />manufacturer’s specifications, suitable for the risks involved. A hose reel that is equipped<br />with foam making capabilities should be identified by conspicuous signage.<br />Hydrant hose systems may be substituted for fire hose reels.<br />(b) Fire hydrants<br />The hose connection points for fire hydrants must have fittings that allow connection to the<br />emergency services authority's mobile appliances without the need to use adaptors.<br />Guidance for the selection, installation and location of fire hydrants for use on premises where<br />dangerous goods are stored and handled can be found in AS 2419. For premises storing or<br />handling flammable and combustible liquids, detailed guidance is included in AS 1940.<br />Further advice may be obtained from the relevant emergency services authority.<br />Hydrants should be equipped with hose, branch and nozzle except where it is not appropriate<br />and prudent to do so, for example, where they are susceptible to theft or there are no<br />personnel properly trained to operate them.<br />External hydrants should be:<br />· positioned convenient to but a safe distance from exit doors;<br />· easily visible, with appropriate identification signs; and<br />· capable of providing the appropriate coverage.<br />55<br />(c) Monitors<br />The installation of monitors may be appropriate where fire control requires the direction of<br />large quantities of fire or cooling water at a fixed installation, with minimum exposure of<br />firefighters.<br />Monitors should normally be installed in consultation with the emergency services authority.<br />The following matters should be taken into account when determining the specification of the<br />monitors and their location:<br />· the design water flow capacity. An allowance of 50% over any calculated capacity should<br />be provided to take account of adverse wind conditions;<br />· the type of nozzle that should be provided – fixed or variable pattern and whether it can<br />supply foam as well as water;<br />· the location of the monitor relative to the installation being protected;<br />· the anticipated heat flux at the monitor location. In situations where the heat flux is likely<br />to exceed 2 kW/m2 the provision of radiant heat protection for personnel operating the<br />monitor should be considered.<br />Monitors should be installed in accordance with the manufacturer’s specifications and would<br />normally be located 15-30 metres from the facility to be protected. If monitors are required to<br />be closer to the facility, or where the expected heat flux may exceed the need for radiant heat,<br />protection for personnel at the premises should be taken into account. This would normally<br />necessitate remote control. The emergency services authority is able to provide advice on the<br />heat flux levels that should be used in determining the placement and operating parameters for<br />any monitors.<br />(d) Automatic sprinkler systems<br />Where fire sprinkler systems are required, they should normally be installed in accordance<br />with AS 2118.<br />Where foam systems are required, advice may be obtained from potential suppliers and the<br />relevant emergency services authority. If necessary, refer to the codes such issued by the<br />National Fire Protection Association (USA) and other specific guidance.<br />(e) Portable fire extinguishers<br />You should select fire extinguishers that are suitable for the fire risk involved, in compliance<br />with the appropriate Australian Standard as listed in Appendix 3.<br />Fire extinguishers should be located, identified and protected so they are:<br />· clearly visible, unobstructed and readily available to the relevant risk; and<br />· not adversely affected by hazardous or climatic conditions.<br />AS 2444 provides guidance on the location and identification of portable fire extinguishers.<br />Where powder-type and foam extinguishers are likely to be used together in an emergency,<br />56<br />they should be compatible.<br />Portable fire extinguishers for special risks<br />· Foam extinguishers should be suitable for the particular dangerous goods. For example, alcoholcompatible<br />foam should be used for alcohols and other polar (water miscible) solvents.<br />· Carbon dioxide extinguishers may protect electrical equipment and will minimise clean up and limit<br />damage to the equipment, but have a poor ‘knock down’ short discharge range, and may be ineffective<br />where there is significant air movement. Dry powder or vaporising liquid may be more effective.<br />· Carbon dioxide and acidic extinguishers such as those based on ammonium phosphate should not be used<br />where there are cyanides present.<br />· Carbon dioxide should not be used on fires involving magnesium or titanium metals.<br />Responding to failure of the fire protection system<br />You must ensure that in the event that any of the components of the fire protection or fire<br />fighting equipment are rendered inoperative:<br />· action is taken to return the fire protection and fire fighting equipment to full operation;<br />· the implications of the equipment becoming unserviceable or inoperative are assessed; and<br />· alternative measures are taken to control, to the same level of effectiveness, those risks that<br />were controlled when the equipment was functioning fully.<br />Fire protection systems and equipment should be inspected and tested at regular intervals to<br />ensure that it is fully operational at all times. Refer to AS 1851 for guidance on testing and<br />inspection.<br />If any of the components of the fire protection system or equipment fail, you must:<br />· assess the implications of the failure;<br />· correct the faults and bring the system back to full operation; and<br />· control risks through alternative measures.<br />In the simple case of a fire extinguisher, this may involve having the extinguisher serviced or<br />replaced. For more complex fixed fire protection systems, making the system fully<br />operational may take time.<br />Alternative control measures may include:<br />· ceasing all or part of the operations in the areas affected by the failure if the risk is high;<br />· providing temporary fire protection systems or equipment until repairs are completed;<br />· notifying the emergency services authority to obtain advice.<br />Maintenance of fire protection equipment<br />All fire protection equipment should be maintained in accordance with the various parts of AS<br />1851 Maintenance of fire protection equipment.<br />57<br />24. Emergency preparedness<br />If you have dangerous goods at your premises in quantities exceeding the “Manifest Quantity”<br />column in Schedule 2 of the Regulations, you must develop a written emergency plan.<br />24.1 Emergency plans<br />Purpose and scope<br />The purpose of the emergency plan is to minimise the effects of any emergency that occurs at<br />premises where larger quantities of dangerous goods are stored and handled.23<br />The emergency plan should be capable of dealing with the worst-case credible scenario.<br />However, detailed planning should concentrate on the more likely events. The emergency<br />plan should also be sufficiently flexible to ensure that an emergency response can be varied<br />according to the severity and type of dangerous occurrence or near miss.<br />Content<br />The emergency plan should include the following matters:<br />Site and<br />Hazard Detail<br />1 Name, location, address and nature of operations<br />2 Detailed map of the facility and surrounding area<br />3 Inventory of Schedule 2 materials<br />4 Maximum/minimum number of persons expected at the facility<br />5 Infrastructure likely to be affected by an incident<br />6 Emergency planning assumptions<br />7 Description of measures to control the consequence of each hazard and<br />major incident<br />Command<br />Structure and<br />Personnel<br />8 Details of emergency contact personnel<br />9 Allocation of personnel for implementing the plan<br />10 Arrangements for “mutual aid” between adjacent facilities<br />Notifications 11 Procedures for providing early warning of an incident<br />12 Details of on-site and off-site warning systems<br />13 Contact details for the emergency services<br />14 Details of on-site communications systems<br />Resources 15 Details of emergency resources on-site<br />16 Arrangement for obtaining additional external resources<br />Procedures 17 Procedures for safe evacuation and muster of personnel<br />18 Details of control points and procedures for essential services<br />19 Procedures for containment of any incident<br />20 Procedures for decontamination following an incident<br />23 “Emergency” means an event that exposes a person or property in the vicinity of the event to an<br />immediate risk through —<br />(a) an explosion, fire, harmful reaction or the evolution of flammable, corrosive or toxic vapours<br />involving dangerous goods; or<br />(b) the escape, spillage or leakage of any dangerous goods.<br />58<br />Development and consultation<br />In developing the emergency plan, you must request the written advice of the emergency<br />services authority and have regard to that written advice.<br />If an emergency may impact beyond the perimeter of your premises, you should also consult<br />with people in control of adjacent premises and the local counter-disaster organisation. Note:<br />if you are required to develop an emergency plan, you will also be required to notify<br />WorkCover in writing that the premises contains quantities of dangerous goods that exceed<br />the “Manifest Quantity”.<br />You may also be required to consult with other authorities responsible for the environment<br />and planning as well as local government, to ensure consistency with legislation and<br />emergency planning, for example, State Emergency Disaster Plans (‘DISPLANS’).<br />Implementing, communicating and maintaining the plan<br />The contents of emergency plans must be communicated to all people who may be exposed to<br />a risk as a result of an emergency, including:<br />· employees;<br />· contractors and sub-contractors; and<br />· people in control of adjacent premises.<br />The emergency plan should be tested when first devised, after each modification and at<br />regular intervals. Simulated emergencies and other exercises should systematically attempt to<br />involve all people likely to be involved in a dangerous occurrence or near miss. These<br />exercises should include practical drills.<br />Emergency plans must be updated whenever:<br />· there is a change of circumstances on or off the premises;<br />· updated information becomes available;<br />· a deficiency in the plan is identified.<br />Accessibility<br />The emergency plan should be in a readily accessible and understandable form. This could be<br />either a hard copy or in a computer format.<br />The location of the emergency plan should be well known to supervisors and employees and<br />discussed with the emergency services authority whenever there is a review or update.<br />It is recommended that a copy be made available to the emergency services authority.<br />24.2 Emergency procedures<br />Emergency procedures should cover all foreseeable emergencies such as fire, spillage of<br />dangerous goods, vapour release and uncontrolled reaction as well as external risks to<br />dangerous goods.<br />59<br />Many effective emergency procedures are simple one-page documents in point form, suitable<br />for display on signs or carrying as a pocket card. Emergency procedures will vary depending<br />on the requirements of the premises, but should contain as a minimum:<br />· the means of raising the alarm;<br />· contact details of the emergency services authority and/or EPA; and<br />· actions to be taken by employees in an emergency.<br />A sample emergency procedures pocket card can be found at Appendix 9.<br />24.3 Emergency equipment<br />Equipment required to contain and clean up escapes, spills or leaks of dangerous goods must<br />be kept on the premises and be accessible at all times. The equipment will vary with the types<br />and quantities of dangerous goods. Examples include:<br />· overpacks such as oversized drums for containing leaking containers;<br />· absorbent material suitable for the substances likely to be spilled;<br />· booms, plates and/or flexible sheeting for preventing spillage from entering drains and<br />waterways;<br />· neutralising agents such as lime or soda ash;<br />· suitable pumps and hoses for removal of spilled material;<br />· hand tools such as mops, buckets, squeegees and bins; and<br />· suitable PPE.<br />You should establish a procedure for the regular maintenance of emergency equipment to<br />ensure that the equipment is in serviceable condition.<br />25. Responding to an emergency<br />You must respond to any emergency by ensuring that immediate action is taken to assess and<br />control any risk associated with the emergency.<br />Only people who are essential to the tasks of assessing and controlling the risk associated<br />with the emergency are permitted to remain in the vicinity of the emergency. Your emergency<br />procedures should specify those essential personnel.<br />Investigating incidents<br />You must investigate all incidents.24 These include dangerous occurrences – commonly<br />referred to as “near misses” – which could have exposed people or property to a risk.<br />The investigation of incidents should be an integral part of the system for managing safety at<br />the premises. The aim should be to ensure that incidents are prevented in the future.<br />24 “Incident”means –<br />(a) an emergency; or<br />(b) an unintended event that, but for the intervention of a risk control measure or human intervention, is<br />likely to have resulted in an emergency.<br />60<br />The investigation must determine the cause or likely cause of the incident that has occurred at<br />the premises. Further, the risk assessment must be reviewed having regard to the results of the<br />investigation, and risk control measures revised accordingly.<br />The system for investigating incidents should:<br />· be prepared in consultation with employees and any health and safety representatives;<br />· be documented so that it is readily understood by people who may be affected; and<br />· inform supervisors, employees, health and safety representatives and other relevant people<br />of the results of the investigation.<br />Recording incident investigations<br />You must make a record of the incident investigation and keep it for at least five years. The<br />record must be readily available to WorkCover.<br />The following should be considered in recording a dangerous occurrence:<br />· Were the on-site or off-site emergency plans activated?<br />· Did the leak or spill have the potential to cause fire, explosion or release of toxic or<br />corrosive materials?<br />· Did the leak or spill have the potential to cause any of the following effects:<br />- acute or chronic human health effects?<br />- environmental harm?<br />- damage to property?<br />· Would the leak or spill affect the quantity or quality of effluent discharged into sewers?<br />· Did the leak or spill need to be reported to the Environment Protection Authority under a<br />site-leak or spill-reporting plan?<br />26. Security of the premises<br />You must, so far as is practicable, prevent access to the premises by unauthorised people.<br />Examples of security measures, depending on the size and hazards of the particular premises,<br />are:<br />· fencing or enclosure of areas where the dangerous goods are kept;<br />· locks on doors, windows and other openings to buildings, rooms, compartments or<br />containers in which dangerous goods are kept;<br />· supervision of areas where the dangerous goods are kept; and<br />· security checks on all vehicles entering or leaving the premises.<br />A system to control access of all people to the premises should include:<br />· the means to identify the extent of access for each person;<br />· the means to account for all people on site at any given time, for example, by the use of a<br />logbook; and<br />· security measures for visitors.<br />61<br />When developing security systems and procedures, you should consider:<br />· the nature of the hazards and the levels of risk;<br />· the likelihood of sabotage;<br />· the integrity and reliability of the security system hardware and design; and<br />· the back-up support for security systems and personnel.<br />People engaged to work at the premises should be trained to ensure that they understand the<br />security measures and security signs provided.<br />27. Visitors to your premises<br />The activities of visitors may lead to increased risk for themselves and other people on the<br />premises. You must guard against this by providing appropriate information, instruction and<br />supervision.<br />Ensure that visitors are properly informed about:<br />· the hazards to which they may be exposed while on the premises;<br />· appropriate safety measures to be applied while on the premises; and<br />· what actions to take if any emergency occurs while they are on premises.<br />The need for a formal system of providing safety information, such as a briefing or written<br />safety information will depend on a number of factors including the:<br />· nature and severity of hazards on the premises;<br />· extent of the premises and the degree of access provided; and<br />· degree of supervision to be provided.<br />In some high-risk situations, it may be necessary to verify through assessment whether<br />visitors have a satisfactory understanding of the safety information.<br />You must also provide appropriate supervision. Consider keeping visitors under constant<br />supervision or at least under observation.<br />62<br />28. Induction, information, training and supervision<br />You must provide appropriate induction, information, training and supervision to all people<br />involved with the storage and handing of dangerous goods.<br />Induction, information and training provide employees with the skills and knowledge they<br />need to perform their jobs safely. It should help them to understand:<br />· the hazards and risks associated with the storage and handling of dangerous goods;<br />· how to follow health and safety procedures;<br />· the reasons risk controls have been set in place and how to use them; and<br />· emergency plans.<br />28.1 Training<br />Who should be trained?<br />You must provide induction, information and training to any person on the premises who is<br />likely to be affected by the dangerous goods. This includes:<br />· your employees and their health and safety representatives, if any; and<br />· any contractors you have engaged to work on the premises.<br />Employees supervising other employees who use dangerous goods should also receive<br />training.<br />When developing and providing training programmes, you should consider any special needs<br />the employees being trained may have, such as specific skills, work experience, physical or<br />intellectual disability, first language, literacy and age.<br />Consider using oral or visual training methods, or conducting training where appropriate in<br />languages other than English. Refer to the Code of Practice for Provision of Occupational<br />Health and Safety Information in Languages other than English for guidance on training in<br />multilingual workplaces.<br />Outcomes of training<br />The required outcomes of training for employees and other personnel on the premises include<br />the ability to demonstrate an understanding of:<br />· safe work practices relating to the storage and handling of dangerous goods that are being<br />used in the workplace;<br />· how to locate an MSDS, and use the information;<br />· the nature of the hazards and risks associated with the duties being performed;<br />· measures used to control risk;<br />· proper use of PPE;<br />· emergency procedures; and<br />· first aid and incident reporting procedures to be followed in case of injury or illness.<br />63<br />Review of training<br />To ensure that training remains effective, you should regularly review the training provided to<br />identify the need for further training. Further training should be provided when:<br />· new dangerous goods are introduced to the premises;<br />· there are changes to the layout of the workplace, work practices or control measures for the<br />dangerous goods; and<br />· new information on the hazards of the dangerous goods is made available (for example, a<br />revised MSDS).<br />You should evaluate information, instruction and training to ensure that the content is clearly<br />understood by employees. Evaluation could take the form of on-the-job observation.<br />Refresher training should be provided as required and induction training for all new<br />employees (and other people engaged to carry out work at the premises) should take place.<br />Limitations of training<br />Although training plays an important part in ensuring effective risk control, it is not a risk<br />control measure in itself. People who are likely to be affected by the dangerous goods at the<br />premises should be aware of the nature of the risk and the role that specific control measures<br />play in risk prevention. However, you should not rely on safe worker behaviour alone. High<br />levels of training and instruction cannot substitute for effective and proper measures to control<br />the risk.<br />28.2 Provision of information<br />Who should receive information?<br />You must provide appropriate information to all people who may be involved with or affected<br />by the storage and handling of dangerous goods, including:<br />· supervisors and employees;<br />· visitors;<br />· contractors, including transport drivers; and<br />· personnel of the emergency services authority.<br />Appropriate information would include MSDS, labels, safety signs and emergency procedure<br />guides.<br />64shahzadhttp://www.blogger.com/profile/01364507074991292353noreply@blogger.comtag:blogger.com,1999:blog-7305327264533069235.post-40456062710551464362009-06-16T21:11:00.003-07:002009-06-19T21:35:49.329-07:00An Overview of the Hazard Identification andStep 1 – Decide who should be involved<br />You have responsibility for carrying out the hazard identification and the risk assessment<br />under Regulations 404 and 405.<br />You should ensure that any person carrying out the assessment is familiar with the<br />requirements of the Regulations and has a practical understanding of the how the dangerous<br />goods are stored and handled at the premises.9<br />A single person such as the works manager or works chemist may be suitably competent to<br />perform simple assessments, while in more complex cases, several people representing a<br />variety of skills will probably need to be involved in collecting and assessing the information.<br />Consult your relevant employees and their health and safety representatives.<br />Step 2 – Hazard Identification<br />Identify all dangerous goods at the premises<br />Identify all dangerous goods stored and handled at the premises and any dangerous goods<br />generated during any manufacturing process. All of these dangerous goods must be<br />considered in the hazard identification and subsequent risk assessment process.<br />The following information should be assembled for each of the dangerous goods present:<br />· the name of the dangerous goods;<br />· the Class, Subsidiary Risk and Packing Group;<br />· if the dangerous goods are in packages, the sizes and numbers of packages of each size;<br />and<br />· if the dangerous goods are in bulk, the identification numbers, capacity and average<br />quantity of dangerous goods in each bulk container.<br />Obtain information about the dangerous goods<br />MSDS and markings on packages for all dangerous goods supplied to the workplace should<br />be reviewed to obtain information on the chemical and physical properties, hazardous<br />properties, precautions for use and safe handling requirements for the dangerous goods.<br />Sources of information<br />Sources of information include:<br />9 If you are considering contracting the services of external consultants, ensure that they have the expertise<br />and experience to do the job competently. Guidance on the selection and effective use of dangerous goods<br />and occupational health and safety consultants can be obtained from the Victorian WorkCover Authority<br />publication Selecting an Occupational Health and Safety Consultant – A Guide for Workplaces.<br />Professional associations, such as the Institution of Engineers Australia and the Royal Australian<br />Chemical institute, may also be able to provide guidance on persons qualified to perform dangerous<br />goods assessments.<br />16<br />· MSDS obtained from manufacturers and suppliers;<br />· package markings;<br />· class information (information about the Class of the dangerous goods indicates a key<br />hazard of the dangerous goods but in itself is generally not sufficient because there are<br />significant differences in the chemical and physical properties of individual products<br />within the class);10<br />· package labels (information on the package itself will generally be insufficient to cover<br />anything more than the most basic use of the product).11<br />Other helpful sources of information include:<br />· National Industrial Chemical Notification and Assessment Scheme (NICNAS) Summary<br />Reports. NICNAS Summary Reports have been produced for every dangerous goods<br />notified and assessed under the Commonwealth Industrial Chemical (Notification and<br />Assessment) Act 1989;<br />· Sources listed in Appendix 1 of the National Code of Practice for the Preparation of<br />Material Safety Data Sheets;<br />· the Victorian WorkCover Authority (WorkCover);<br />· NOHSC (formerly known as Worksafe Australia);<br />· trade unions and employer associations;<br />· industry associations; and<br />· occupational health and safety consultants.<br />Consider external sources of information on dangerous occurrences, such as:<br />· manufacturers or suppliers of the dangerous goods or equipment;<br />· fire services; and<br />· published literature.<br />You may wish to include a requirement in all supply contracts that your suppliers identify all<br />known hazards associated with the containers and accessories used to store the dangerous<br />goods, any spill containment used, plant and the fire protection system.<br />Review information about dangerous goods<br />To identify hazards effectively, you must look at how the dangerous goods are stored and<br />handled. Therefore, when reviewing the information about dangerous goods, you should<br />consider the following factors:<br />10 The ADG Code has information about the relative hazards of Classes, and Subsidiary Risks and the<br />characteristics of Packing Groups.<br />11 Package labels provide some information about the hazards associated with dangerous goods. Some<br />products – for example, dangerous goods in consumer packages - may have sufficient information on the<br />consumer package label to cover most likely situations of handling, such as the clean up and proper<br />disposal of spills.<br />17<br />(a) The inherent hazards of the dangerous goods, for example:<br />· fire;<br />· explosion;<br />· toxic effects<br />- inhalation;<br />- ingestion (swallowing contaminated food or eating or smoking with contaminated<br />hands);<br />- absorption through the skin or eyes; or<br />- corrosive action.<br />(b) The form (including concentration) in which the dangerous goods may be present, such<br />as solid, liquid or gas; supplied as packaged dangerous goods or in bulk. For example,<br />some goods may be virtually harmless in some forms (such as a block of metal) but may<br />become very hazardous dangerous goods in another form (such as a fine dust that can be<br />readily ignited or may be highly reactive).<br />(c) The chemical and physical properties. For example, gases or liquids with low boiling<br />points or high vapour pressures can give rise to high airborne concentrations in most<br />circumstances, whereas high boiling point liquids such as oils are only likely to create<br />an explosive airborne concentration if they are heated or sprayed. Dangerous goods with<br />a very low or high pH (ie. acids and caustics respectively) are corrosive to the skin and<br />eyes and corrosive to metals. Some dangerous goods are chemically unstable or highly<br />reactive (for example, many organic peroxides) and may self-react or react with other<br />materials to cause a fire or explosion. This information may include:<br />· physical state – solid / liquid / gas;<br />– if solid – what potential for dust cloud explosion?<br />– if liquid – mobile / viscous / volatile / miscible?<br />– if gas – lighter / heavier than air?<br />· flashpoint, firepoint and explosive limits;<br />· viscosity;<br />· density;<br />· particle size;<br />· vapour pressure;<br />· solubility and pH;<br />· reactivity;<br />· boiling and/or freezing point or range;<br />· electrical and/or heat conductivity; and<br />· the nature and concentration of combustion products.<br />(d) The types of incidents. For example, a Class 3 (flammable) dangerous goods may have<br />a very low flashpoint of – 5oC (that is, they are highly volatile) and under most ambient<br />conditions would able to ignite (within its explosive limits) when exposed to the<br />atmosphere. A high flashpoint product with a flashpoint of 56oC cannot be ignited<br />easily at ambient temperatures. The volatility of the dangerous goods will also affect the<br />likely intensity of any fire. Other characteristics like the mobility of a liquid (ie whether<br />it is thick like honey or thin like water) will determine how far a spill would spread and<br />in turn affect the spread of a fire.<br />18<br />How factors can vary for different dangerous goods – petrol and caustic soda<br />Petrol and sodium hydroxide (caustic soda) are both dangerous goods, yet each has very different properties<br />that make them dangerous.<br />Petrol is dangerous principally because it is flammable, so the identification of hazards and the assessment of<br />risk should be based on the potential for fire and explosion. Petrol has other properties that may result in risk.<br />It can act as a solvent and dissolve other hydrocarbons like greases, and can dissolve or weaken certain types<br />of plastics. The assessment of risk should include whether there is potential to affect the operation of any plant<br />or weaken plastic structures through contact with petrol.<br />In contrast, even brief exposures to high concentrations of sodium hydroxide may lead to immediate effects<br />which include irritation or burning of the skin, eyes and respiratory tract. Sodium hydroxide is also corrosive<br />to metals and may react with other substances, particularly dangerous goods that are acidic. Evaluation of<br />risks for sodium hydroxide must therefore consider the potential for risk through a range of different<br />pathways.<br />How are the dangerous goods stored and handled?<br />Once you have identified the dangerous goods on your premises and reviewed the available<br />information you need to consider if the way the goods are stored and handled creates a hazard.<br />You must identify any hazards arising from:<br />Manufacturing and transport processes<br />· Are there any hazardous chemical and physical effects that may arise during the<br />manufacturing or transport process?<br />· Are procedures and operating parameters being adhered to?<br />An example of the need to determine and adhere to safe operating parameters is where a liquefied gas is being<br />pumped. A reduction in pressure on the suction side of the pump may result in the gas partially vaporising<br />before it enters the pump and causing a vapour lock within the pump. As a result, the pump stops pumping<br />liquid and instead recirculates a pocket of vapour that may cause the pump to overheat and fail<br />catastrophically unless safety controls have been specifically provided to detect such a condition and shut the<br />pump down before a failure occurs.<br />Structures, plant and system of work<br />Hazard identification for structures, equipment, systems of work and activities used in the<br />storage and handling of dangerous goods primarily involves the identification of all:<br />· physical components or characteristics which have the potential to cause harm;<br />· systems of work, including normal operating procedures and unusual operating conditions,<br />which could give rise to harm or damage;<br />· the possibility of operator error; and<br />· activities which may pose a threat to the dangerous goods.<br />It is important to observe and consult with employees to find out how the job is actually done.<br />People do not always work ‘by the book’, and may devise their own methods of work. Also,<br />find out what happens during cleaning, maintenance and breakdowns, and during staff<br />absences or shortages. Where you identify a difference between the way the system of work is<br />set out and the way it is implemented you should examine the reasons for the difference.<br />19<br />Structures, plant, system of work and activities not used in the storage and handling of<br />dangerous goods<br />Some activities, systems of work, structures and equipment that are not directly involved with<br />the storage and handling of dangerous goods may constitute a hazard to the storage and<br />handling of the dangerous goods. An example of an external fire hazard could be the<br />development of a timber yard adjacent to the premises. Depending on the proximity of the<br />timber yard and stacks of timber to where the dangerous goods are stored and handled, a fire<br />at the timber yard could result in the dangerous goods becoming involved.<br />Consider the following hazard sources:<br />· Are there any dangerous goods stored near your premises?<br />· Do any of these activities on the premises occur?<br />- operation of plant;<br />- movement of vehicles;<br />- deliveries of dangerous goods;<br />- personnel movements in normal and emergency situations;<br />- visitor access;<br />· Are there any fire hazards, including concentrations of combustible material (for example,<br />a timber store or a store of C2 combustible liquids12) or uncontrolled vegetation on or off<br />the premises?<br />· Are there any activities and installations on neighbouring premises that could create a<br />hazard?<br />· What is the effect of a main road, railway line, airport, gas pipeline, water main, high<br />voltage power lines and radio transmitters including mobile phone repeater towers?<br />· Could nearby facilities such as schools, hospitals, child and aged care facilities, theatres,<br />shopping centres and residences be affected?<br />Chemical and physical reaction between dangerous goods and other substances and<br />articles<br />Physical reactions include dilution, dissolution, abrasion, phase change, leaching and<br />adsorption. Chemical reactions are reactions that result in a chemical change in one or more<br />of the goods when they come into contact with one another.<br />Consider:<br />· Is there a hazard as a result of a physical reaction from incompatible substances coming<br />into contact, for example, explosion or heat rapidly generated from acid mixing with<br />water?<br />· Is there a hazard as a result of a chemical reaction from different substances coming into<br />contact, for example, an oxidising agent such as pool chlorine mixing with a hydrocarbon<br />such as oil or brake fluid?<br />A list of the chemical and physical properties to be considered when identifying hazards<br />associated with the storage and handling of dangerous goods is at Appendix 5.<br />12 A definition of C2 Combustible liquids is in AS 1940<br />20<br />Physical reaction<br />An example of a hazard arising from dilution is the mixing of acid and water. The addition of a small amount<br />of a concentrated acid to a large quantity of water may result in some heat being generated through the<br />dilution of the acid in the water but no hazard since the heat generated during dilution is quickly dissipated in<br />the water. On the other hand, the addition of a small amount of water to a large quantity of concentrated acid<br />may result in rapid boiling of the water as it dilutes the acid. If the heat generated can’t dissipate quickly<br />enough, the effect may be explosive. The hazard is the potential for hot acid to be splashed around.<br />Chemical reaction<br />The combination of an oxidising agent (pool chlorine) and a hydrocarbon (oil, brake fluid) can result in a very<br />intense fire that is difficult to extinguish. Not all chemical reactions will be hazardous – for example, the<br />combination of a weak acid and a weak alkali will result in a neutralisation reaction that is relatively nonhazardous.<br />However, the combination of concentrated solutions of the same products may result in a violent<br />reaction that can be explosive or generate a great deal of heat and may result in hot acid and alkali being<br />splashed around.<br />Type and characteristics of incidents<br />Incident information contributes to the state of knowledge of the dangerous goods and their<br />storage and handling. Consider:<br />· What types of incidents have occurred when storing or handling dangerous goods at your<br />premises?<br />· What is known about how these incidents were caused?<br />· What information is available about the effectiveness of risk controls and about how risk<br />controls can be improved?<br />· Have you taken into account incidents that have occurred at your premises and other<br />facilities storing and handling similar types of dangerous goods?<br />Step 3 – Risk assessment<br />The final step in the risk management process is to assess the risks associated with the<br />hazards. Risk assessment determines whether there is a risk of injury to people or damage to<br />property from the storage and handling of dangerous goods at the premises. The purpose of<br />the risk assessment is to:<br />· determine those risks that need to be controlled; and<br />· assist you to make decisions about the order in which risks should be controlled.<br />When carrying out a risk assessment, the Regulations require you to take account of the<br />information and knowledge gained about the dangerous goods and the matters that affect<br />safety in relation to the storage and handling of those goods.<br />Make sure that health and safety representatives are consulted at all stages of the risk<br />assessment process.<br />There are a number of methods for carrying out a risk assessment. At premises where<br />complex dangerous goods processes are involved, for example, chemical manufacturing<br />processes, it may be more effective to use a more highly structured process such a Hazard and<br />Operability Studies (HAZOP) or Hazard Analysis (HAZAN) to guide the hazard<br />identification and risk assessment process. In some situations it may be necessary to<br />21<br />undertake quantitative risk analysis (QRA) to assist in the understanding of the extent of the<br />risks involved. More information about risk assessment is available in AS/NZS 4360.<br />What are the consequences of an incident?<br />In assessing the consequences of an incident, consider the potential:<br />· injuries and illness to people and property damage at the premises;<br />· for ‘knock on effects’ involving other dangerous goods at the premises;<br />· for injuries and illness to people and property damage outside the premises.<br />Assessing consequence: escape of volatile flammable liquid<br />A flash fire hazard has been identified with an escape of a large amount of volatile flammable liquid into the<br />spillage catchment area of a large bulk storage tank. Calculations show that a vapour cloud from the spill may<br />travel over a hundred metres from the catchment area before the concentration is reduced below the point at<br />which the vapour can be ignited (the lower flammable limit). The consequence of the ignition of the large<br />vapour cloud is that anyone inside the flammable portion of the cloud will be severely injured and it is likely<br />that any flammable material or construction will be ignited.<br />If the flammable portion of the vapour cloud could travel beyond the property boundary, the potential injury<br />and property damage outside needs to be determined.<br />If there is a labour-intensive manufacturing business within the potential envelope of the flammable vapour<br />from the spill, many people may be injured or even killed.<br />What is the likelihood that the hazard will result in an incident?<br />The next step is to estimate the likelihood that the hazard may cause an incident.<br />Look at historical records and review incident information from the premises and from similar<br />types of industries. People who work at the premises are a very useful source of information.<br />If the particular storage and handling operation is complex or is very high risk, a Quantified<br />Risk Assessment (QRA) may be needed.<br />Estimating likelihood: example<br />An explosion hazard has been identified in relation to the welding of drums that once contained flammable<br />and combustible liquid. The consequences of an explosion involving the tank are severe because it is likely to<br />cause the death of the person doing the welding.<br />The person carrying out the risk assessment talks to management and supervisors to find out how often drums<br />are welded. The health and safety representative and workers are also consulted about the hazard. The<br />combined history of those involved shows that welding of drums has happened very infrequently and no one<br />knows whether the drums contained flammable or combustible material.<br />The risk assessment concludes that the welding operation is likely to cause an incident. It has happened and is<br />likely to happen again if steps are not taken.<br />22<br />17.2 Generic risk assessment<br />Often, particular dangerous goods are used in the same or similar way in a number of different<br />premises, or in areas within the same premises. Because the nature of the hazard and the risk<br />in these cases may be similar, you are permitted to make a single assessment of one<br />representative situation and apply it to the other areas or premises. By performing generic<br />assessments, you can minimise the duplication of assessments, thereby streamlining the risk<br />assessment process. As with risk assessments generally, you must consult with employees and<br />health and safety representatives and any other people you have engaged at the premises,<br />when carrying out generic risk assessments.<br />You are responsible for ensuring that the generic assessment is valid for each of the premises<br />or areas to which it is intended to apply. A generic assessment is valid if both the dangerous<br />goods and their storage and handling are essentially similar. For example, a factory<br />repackages Class 3 dangerous goods and has four separate packaging lines that are the same<br />and are able to repackage the same range of products. The hazard identification and<br />subsequent risk assessment needs only to be done on one of the packaging lines and applied to<br />the other three. Similarly, if a generic assessment is undertaken by a trade association as a<br />model to be used by a number of different occupiers with essentially identical premises – for<br />example, service stations and retailers – the individual occupier is responsible for ensuring<br />that the assessment is valid for his or her own workplace. An example of an Australian<br />Standard that can be used in this generic way is AS 1596 – Storage and handling of LP Gas.<br />This Code refers to a range of Australian Standards and specific industry publications. In<br />many instances the risk controls identified in those documents have been formulated<br />following analysis of particular hazards and their risks. You may rely on the generic<br />assessments when the control measures stated in the documents are implemented and directly<br />applicable to the storage and handling situation to which they are applied. In those<br />circumstances you should identify the hazards being controlled and refer to the Standard<br />being relied on for the generic assessment.<br />If the situations are not similar and employees in different premises or areas of the same<br />premises may be subjected to different risks, a generic risk assessment cannot be performed or<br />may need to be supplemented to address those different risks.<br />17.3 Recording the outcomes of risk assessments<br />Outcomes of risk assessments must always be documented. Risk assessment records should<br />include:<br />· name(s) of the assessor(s);<br />· date of the assessment;<br />· the premises/area/process;<br />· the dangerous goods for which the MSDS or equivalent information has been reviewed;<br />· the controls in place to prevent a risk;<br />· the nature of risk identified; and<br />· why decisions about the risk were made.<br />23<br />The record of the result of the assessment must be accessible to any person engaged to work<br />at the premises who could be exposed to a risk, and their health and safety representatives.<br />An extensive record of the assessment is not required if you have identified that the storage<br />and handling of the dangerous goods does not result in a risk that needs to be controlled.<br />A record of the risk assessment should be of assistance when undertaking any subsequent risk<br />assessments that may be necessary because of changes to the dangerous goods used, systems<br />of work, plant, structures or other circumstances that could result in change to the risk profile<br />of the premises.<br />17.4 Reviewing and revising risk assessments<br />A risk assessment may no longer adequately assesses the risk associated with the storage and<br />handling of particular dangerous goods. In this case, the risk assessment must be reviewed<br />and, if necessary, revised. The assessment needs to be revised if:<br />· a new dangerous goods is introduced into the premises;<br />· the process or plant is modified;<br />· new information on the hazards of the dangerous goods becomes available;<br />· monitoring indicates inadequate risk control;<br />· incidents or near misses have occurred which may be due to inadequate control; or<br />· new or improved control measures become available or practicable.<br />Where it is known that circumstances will change, you may be able to prepare a risk<br />assessment that takes the projected or known changes into account. In this way, you can<br />ensure that the assessment will continue to deal with the risk adequately after the changes take<br />place.<br />In any case, a risk assessment must be reviewed at intervals not exceeding five years. If the<br />assessment remains correct (that is, it adequately assesses the risk), simply record the date of<br />review.<br />18. Risk control<br />18.1 What is risk control?<br />Risk control is the process of determining and implementing appropriate measures to control<br />the risks associated with the storage and handling of dangerous goods.<br />When planning and implementing risk control measures you must consult with your<br />employees and any other people you engage to carry out work at your premises that are likely<br />to be affected by the dangerous goods.<br />18.2 What does ‘practicable’ mean?<br />“Practicable” does not just mean the cost in dollar terms. To determine what is practicable,<br />you, as a duty holder, must take into account:<br />24<br />(a) severity of the hazard or risk in question<br />How likely is it that the storage and handling of the dangerous goods will result in<br />injury to people or the likelihood of damage occurring to property? How serious are the<br />injuries and property damage likely to be and how many people could be affected?<br />(b) state of knowledge about that hazard or risk and any ways of removing or<br />mitigating that hazard or risk<br />What is known about the hazards or risks associated with the storage and handling of<br />the dangerous goods, and the ways to control the risk? What do manufacturers and<br />suppliers of dangerous goods know about the hazards and risks? What do workplaces<br />dealing with similar dangerous goods do to control the risk? What information can<br />industry professionals and organisation, unions and government agencies provide?<br />(c) availability and suitability of ways to remove or mitigate that hazard or risk<br />Are the risk controls that you have identified readily available? Are they suitable for the<br />premises and the employees involved?<br />(d) cost of removing or mitigating that hazard or risk<br />Are the costs of implementing the risk control commensurate with the benefits gained?<br />Time and money invested in selecting and implementing risk controls should result in<br />the elimination or significant reduction in risks from using dangerous goods.<br />18.3 The duty to control risk<br />You have a duty to ensure that any risk associated with the storage and handling of dangerous<br />goods at your premises is controlled. The primary duty is to eliminate the risk. If this is not<br />practicable, the risk must be reduced so far as is practicable.<br />The Regulations also place some specific duties on you to control risks associated with<br />particular aspects of storage and handling of dangerous goods. Giving effect to these specific<br />duties does not displace your general obligation to control risk. Figure 4 summarises the<br />duties of occupiers to control risks.<br />The Australian Standards and other documents that are listed in Appendix 3 provide specific<br />guidance on risk controls that can be applied to address specific hazards associated with the<br />storage and handling of dangerous goods. The duty to control risks can be met for many<br />identified risks by applying the risk controls that are specified in those documents. The use of<br />the risk controls is subject to the conditions of storage and handling at the premises being the<br />same or sufficiently similar that the specific and generic controls in the documents are<br />applicable to those situations. In many instances the documents will provide specific risk<br />controls that are able to address many of the risk control duties in the Regulations.<br />25<br />Figure 4: Summary of occupiers duties to control risks in regulations 407-425<br />General risk control<br />duties Specific risk control duties<br />Control the risk<br />r.407<br />Eliminate use<br />Substitution<br />Engineering<br />Isolation<br />Administrative<br />PPE<br />r.411<br />Interaction with<br />substances and<br />unrelated plant<br />r.416/7<br />Bulk containers<br />r.419<br />Isolation<br />r.415<br />Stability<br />r.414<br />Decommissioned<br />containers r.420<br />Ignition sources<br />r.424<br />Spill containment<br />r.422shahzadhttp://www.blogger.com/profile/01364507074991292353noreply@blogger.comtag:blogger.com,1999:blog-7305327264533069235.post-47523540939763773942009-06-16T21:11:00.002-07:002009-06-19T21:33:28.467-07:00DUTIES OF OCCUPIERS ,Dangerous Goods Act 1985. Introduction<br />This Part is designed to assist occupiers6 in meeting the requirements of the Regulations. If<br />you are an occupier, you have duties to identify hazards and assess and control risks arising<br />from the storage and handling of dangerous goods. You also have duties to consult with<br />employees and health and safety representatives, and provide employees and other affected<br />people on the premises with induction, information, training and supervision.<br />14. Consultation<br />You must consult with employees and their health and safety representative(s), and any other<br />people you engage to carry out work at the premises who are likely to be affected by the<br />dangerous goods, regarding:<br />· hazard identification, risk assessment, risk control;<br />· induction, information and training; and<br />· any proposed changes likely to affect their health or safety arising from the dangerous<br />goods.<br />Consultation should take place as early as possible in planning the introduction of new or<br />modified tasks or procedures associated with the storage and handling of dangerous goods to<br />allow for changes arising from consultation to be incorporated. Consultative procedures<br />should allow enough time for the health and safety representatives to discuss the issue with<br />their designated work group employees and with you.<br />Techniques for organising consultation<br />Effective consultation depends on communication – that is, understanding the people being<br />consulted and providing them with adequate information in a format appropriate to their<br />needs, to enable them to have informed views. The process used for consultation should<br />consider the needs of non-English speaking background health and safety representatives and<br />employees. Guidance on techniques for consultation in multilingual workplaces is provided in<br />the Code of Practice for Provision of Occupational Health and Safety Information in<br />Languages other than English.<br />6 An occupier is defined in the Dangerous Goods Act 1985. An occupier, in relation to any premises<br />(other than licensed premises that are a vehicle or boat), includes a person who—<br />(a) is the owner of the premises;<br />(b) exercises control at the premises under a mortgage, lease or franchise; or<br />(c) is normally or occasionally in charge of or exercising control or supervision at the premises as a<br />manager or employee or in any other capacity.<br />11<br />15. Material Safety Data Sheets<br />15.1 Obtaining an MSDS<br />The Regulations require you to obtain the current version of the MSDS from the manufacturer<br />or first supplier on or before the first time the dangerous goods are supplied.<br />Generic MSDS are not acceptable.7 You may use commercially available MSDS databases<br />provided they contain the manufacturer’s or first supplier’s current MSDS. You need to<br />ensure that the MSDS obtained from such a database is the authorised version prepared by the<br />manufacturer or first supplier.<br />It is good practice to ask for a current copy of the MSDS before the dangerous goods are first<br />supplied, as this will enable you to begin planning for its safe use. Manufacturers, first<br />suppliers and suppliers have an obligation to provide you with a copy on request.<br />If an MSDS is not made available, you should ask the manufacturer, first supplier or supplier<br />whether the goods have been determined to be dangerous goods according to the Regulations.<br />If the supplier informs you that the goods are not dangerous goods, it is advisable to obtain<br />written confirmation.<br />If you are not satisfied with the MSDS provided, raise your concerns with the manufacturer or<br />first supplier. The same dangerous goods may also be available from a manufacturer or first<br />supplier who does provide an adequate MSDS.<br />When is an MSDS not required?<br />If you are a retailer or retail warehouse operator, you are not required to obtain MSDS for<br />dangerous goods stored and handled at the retail outlet in consumer packages that are<br />intended for retail sale. An MSDS is also not required for any dangerous goods in transit on<br />the premises.8 However, for those dangerous goods for which an MSDS has not been<br />obtained, you must have alternative relevant health and safety information readily accessible.<br />This information will enable employees and emergency services authority personnel to deal<br />with incidents such as spillages and damaged consumer packages.<br />Note that if the consumer package is opened or used at the retail outlet, an MSDS is required.<br />15.2 Providing access to MSDS<br />The MSDS must be readily accessible to all employees, other person on the premises and<br />emergency services authority personnel.<br />7 A generic MSDS is one that applies to a class of dangerous goods or a product but has not been prepared<br />specifically for the manufacturer’s product. Generic MSDS may be used as supplementary information or<br />wherever the Regulations impose duties to have “other information” available.<br />8 “Dangerous goods in transit” means dangerous goods that –<br />(a) are supplied to premises in containers that are not opened at the premises; and<br />(b) are not used at the premises; and<br />(c) are kept at the premises for a period of not more than 5 consecutive days.<br />12<br />Copies of MSDS should be kept in a convenient location at the premises where the dangerous<br />goods are stored and handled. Make sure that all relevant personnel on the premises know<br />where to find the MSDS. You should also provide your employees with information or<br />training on the purpose of MSDS and how to use them effectively. (See section 28 on<br />information, instruction and training).<br />MSDS may be provided in a number of ways including:<br />· hard copy;<br />· microfiche; and<br />· computerised MSDS databases.<br />In each case, you should ensure that any storage or retrieval equipment is kept in good<br />working order and all relevant people know how to access the information.<br />15.3 Ensuring that information in the MSDS is not altered<br />You must not alter information in an MSDS prepared by the manufacturer or first supplier.<br />Additional information may be appended to the MSDS, but it must be marked clearly to<br />indicate that it is not part of the original. Similarly, you may re-format or summarise the<br />information contained in the MSDS, as long as it is appended to the original and clearly<br />marked as a reformatted version.<br />16. Register of dangerous goods<br />You are required to keep a register for dangerous goods kept at the premises.<br />The register is simply a list of the product names of all dangerous goods stored and handled in<br />the workplace accompanied, where required, by the current MSDS for each of these<br />dangerous goods. If you are required to keep a register by the Occupational Health and Safety<br />(Hazardous Substances) Regulations 1999 you may combine that register with one required<br />by the Storage and Handling Regulations.<br />The only dangerous goods that do not have to be included in the register are:<br />· dangerous goods in packages of a size that do not have to be marked under the ADG Code;<br />and<br />· dangerous goods in transit.<br />The register must be maintained to ensure it is current. Update the register when:<br />· new dangerous goods are introduced to the workplace;<br />· the use of existing dangerous goods are discontinued; and<br />· the manufacturer, first supplier or supplier provides a revised MSDS.<br />Since manufacturers or first suppliers are required to review, and where necessary, revise<br />MSDS at least every 5 years, all MSDS in the register or otherwise accessible in the<br />workplace should have issue dates within the last 5 years.<br />13<br />If the use of a dangerous good is to be permanently discontinued, you should remove it from<br />the register. Dangerous goods used periodically or seasonally do not need to be removed from<br />the register.<br />The register must be readily accessible to any employee at the premises and any other person<br />who is likely to be affected by the dangerous goods on the premises. Keep it in a central<br />location, or provide a copy of it to each work area.<br />Don’t confuse a register with a manifest. A manifest provides information to the fire brigade<br />in the event of an emergency while a register provides information to assist you in the<br />management of dangerous goods in your workplace. However, some of the information will<br />be duplicated in a register and manifest and you could combine them in one document.<br />17. Risk management<br />The Regulations require you to control risks associated with the storage and handling of<br />dangerous goods at a premises. To do this effectively you must identify the hazards that<br />contribute to the risks and assess the likelihood of those hazards causing injury or damage to<br />property.<br />Hazard identification and risk assessment can be simple and straightforward or highly<br />complex. For example, the storage of only one or two classes of dangerous goods at retail<br />outlets where handling is limited to placing the goods on shelving for display is a relatively<br />simple case and the hazard identification and risk assessments for the activity should be<br />simple.<br />A major warehouse handling a large range of dangerous goods or a chemical manufacturing<br />plant are likely to require detailed investigations of hazards and risks, involving people who<br />have specialist knowledge of:<br />· the dangerous goods;<br />· the processing of those goods; and<br />· the work practices employed in connection with dangerous goods.<br />17.1 How do I carry out a hazard identification and risk assessment<br />process?<br />The following step-by-step guide is intended to lead you through the hazard identification and<br />risk assessment process. It can be used at any premises where dangerous goods are stored or<br />handled. The flow diagram (Figure 3) provides a helpful summary of the process.<br />14<br />Figure 3: Flow diagram<br />Decide who should be<br />involved<br />identify all the dangerous<br />goods<br />Identify hazards in storage<br />and handling processes<br />Risk assessment<br />Are there<br />risks?<br />Record results<br />of the risk<br />assessment<br />Record results<br />of the risk<br />assessment<br />Risk<br />control<br />Review risk<br />assessment<br />Step 1<br />Step 2<br />Step 3<br />Uncertainshahzadhttp://www.blogger.com/profile/01364507074991292353noreply@blogger.comtag:blogger.com,1999:blog-7305327264533069235.post-31143908438926794442009-06-16T21:11:00.001-07:002009-06-19T21:29:44.755-07:00Dangerous Goods Act,DUTIES OF MANUFACTURERS AND SUPPLIERSDUTIES OF MANUFACTURERS AND<br />SUPPLIERS<br />7. Introduction<br />This Part of the Code provides guidance for those who manufacture dangerous goods and<br />supply them for use. When purchasers are making decisions about how to protect the health of<br />employees using dangerous goods, they will rely on the information you provide, so it is vital<br />that you comply with the Regulations.<br />If you manufacture dangerous goods or are the “first supplier”2 of dangerous goods, the<br />Regulations require you to determine whether the goods are dangerous goods. If you<br />determine that the goods are dangerous goods, you must also prepare and provide purchasers<br />with a material safety data sheet (MSDS) and ensure that the dangerous goods are assigned a<br />class, subsidiary risk and packing group, and ensure compliance with Commonwealth<br />legislation covering package marking (see Figure 2).<br />If you supply dangerous goods to premises for exchange or sale, you must provide purchasers<br />with a copy of the MSDS and ensure that the condition of the dangerous goods and the<br />packages and package marking complies with Commonwealth legislation.<br />Figure 2: Duties of manufacturers and first suppliers<br />Determination Provide information<br />8. Are the goods “dangerous goods”?<br />If you suspect (or reasonably ought to suspect) that goods you manufacture or supply as a first<br />supplier are dangerous goods, you are required to determine if this is the case. This<br />determination must be made before the goods are supplied for use.<br />Whether you “reasonably ought” to suspect that goods are dangerous goods is an objective<br />test. That is, it does not depend on your personal knowledge but whether you, as a person in<br />2 “First supplier”, in relation to dangerous goods, means a person who –<br />(a) has not manufactured the dangerous goods; and<br />(b) is, or intends to be, the first person to supply the dangerous goods to another person.<br />Ordinarily, the “first supplier” will be the person who imports the dangerous goods into Victoria from<br />overseas or another Australian jurisdiction (that is, another Australian state or territory).<br />Prepare material Provide MSDS<br />safety data sheet<br />(MSDS)<br />Packaging and<br />marking<br />Determine if<br />goods are<br />dangerous<br />goods<br />5<br />the business of manufacturing or importing those goods, ought to suspect that the goods are<br />dangerous goods.<br />The determination must be made having regard to one of the following:<br />· regulation 2.2 of the Commonwealth Road Transport Reform (Dangerous Goods)<br />Regulations 1997;<br />· for C1 combustible liquids, Australian Standard AS 1940 – The Storage and Handling of<br />Flammable and Combustible Liquids;<br />· for goods that are too dangerous to be transported, an order-in-council made under section<br />9B of the Dangerous Goods Act titled “Goods too dangerous to be transported – Declared<br />dangerous goods”.<br />9. Classifying, packaging and package marking<br />Before the dangerous goods are supplied for use, you are required to ensure that the<br />dangerous goods are:<br />· assigned the appropriate Class, Subsidiary Risk and Packing Group; and<br />· packed in accordance with the ADG Code, with particular emphasis on the need for<br />packagings to be in sound condition and compatible with the goods.<br />The ADG Code requires dangerous goods containers (most packagings and all bulk<br />containers) to be performance tested, approved and marked to indicate the types of dangerous<br />goods for which they are approved. Approvals may be issued in any State under its respective<br />laws adopting the ADG Code and are valid in all States.<br />10. Retailing dangerous goods<br />The requirement to package and mark dangerous goods does not apply to retailers of<br />dangerous goods who supply the goods in a container provided by the purchaser. But if you<br />are retailing dangerous goods, you are still required to ensure, as far as practicable3, the<br />container is suitable. To determine this, consider the following:<br />· Is this type of container usually used for goods of this kind? If not, is it strong enough and<br />unlikely to be affected by the dangerous goods?<br />· Does the container have a tight-fitting lid that will prevent the goods leaking or being<br />spilt?<br />If you are supplying Class 2 dangerous goods (gases), the container provided by the purchaser<br />must comply with the provisions of the Road Transport Reform (Dangerous Goods)<br />Regulations 1997 concerning packages.<br />3 “Practicable” means practicable having regard to –<br />(a) the severity of the hazard or risk in question; and<br />(b) the state of knowledge about that hazard or risk and any ways of removing or mitigating that hazard or<br />risk; and<br />(c) the availability and suitability of ways to remove or mitigate that hazard or risk; and<br />(d) the cost of removing or mitigating that hazard or risk.<br />6<br />If the dangerous goods to be supplied is a liquid fuel, containers that comply with AS 2906<br />Fuel Containers – Portable – Plastics and Metal should be used. Containers that are made to<br />this standard will be indelibly marked (that is, embossed or moulded) with various safety<br />information, including the type and quantity of the fuel that may be placed in the container.<br />Other metal containers may be filled with fuel provided that they are of substantial<br />construction and have a closure, such as a screw top, that can’t easily be dislodged.<br />A fuel tank designed to be detached from an engine or vehicle (for example, a boat) may also<br />be used as a fuel container.<br />Refer to Part 4 for detailed guidance on retailer’s duties.<br />11. Filling gas cylinders<br />Gas cylinders manufactured in Australia are marked in accordance with the provisions of AS<br />2030 to indicate that they have been physically tested. The test mark indicates that the<br />cylinder has been tested to withstand its design pressure, and specifies the period for which<br />the test is valid (commonly 10 years).<br />A gas cylinder manufactured overseas should be manufactured to a standard that is<br />comparable to AS 2030. The cylinder should also be marked with a test mark and test date<br />that provides the same level of information as that in AS 2030.<br />A cylinder with a current test mark can be filled, subject to other criteria. These include:<br />· Is the cylinder in good condition? Cylinders that are damaged or very corroded should not<br />be filled.<br />· Is the cylinder compatible with the gas being filled? Cylinders are generally designed for<br />specific types of gases and have fittings that are only suitable for those gases. They should<br />only be filled with the gases for which they have been designed. Often the cylinder is<br />distinctively marked to ensure that it is easy to identify as suitable for a particular gas. For<br />example, oxygen cylinders and acetylene cylinders are painted different colours and are<br />fitted with different valve assemblies. Are the valves and fittings in good working order,<br />and any protective devices such as neck rings and shrouds in good condition?<br />· Are you using the right equipment?<br />· Cylinders should only be filled using equipment specifically designed for that purpose.<br />Generally, the use of adaptors is discouraged unless it has been authorised by the original<br />supplier of the gas or the manufacturer of the cylinder.<br />7<br />12. Preparing a Material Safety Data Sheet<br />12.1 What information do I have to include on a MSDS?<br />You are required to prepare an MSDS for all dangerous goods covered by the Regulations,<br />other than C1 combustible liquids.<br />An MSDS is a document that describes the dangerous goods and provides vital information to<br />help people use them safely.<br />MSDS must be written in English and include the following information:<br />· the date of preparation or, if the MSDS has been reviewed, the date it was last reviewed;<br />· the manufacturer’s or first supplier’s name and their Australian address and telephone<br />number;<br />· telephone number for information in the event of an emergency;<br />· the product name of the dangerous goods, together with:<br />- the proper shipping name, UN number, class, subsidiary risk and packing group;<br />- its chemical and physical properties;<br />- the names of the individual ingredients in the dangerous goods;<br />- the proportion or proportion ranges of the ingredients identified with a chemical or<br />generic name;<br />- any relevant health hazard information, including first aid information;<br />- information on the precautions for the safe use of the dangerous goods; and<br />· a statement that the goods are dangerous goods.<br />For dangerous goods that may be unstable except under controlled conditions of storage<br />and/or chemical composition, the MSDS must provide details of those conditions and specify<br />the recommended proportion and safe limits for each chemical making up the dangerous<br />goods. For example, ethylene oxide gas depends on the addition of an inhibitor to ensure that<br />it remains chemically stable and does not start to polymerise.<br />The MSDS should be clear and easily understood. Avoid technical jargon as much as possible<br />and explain any technical terms that you have to used. Don’t use vague phrases such as “may<br />be dangerous” or “safe under most conditions of use”.<br />There is no particular format required for an MSDS as long as you include the minimum<br />information required under the Regulations. Formats based on the following are acceptable:<br />· the National Code of Practice for the Preparation of Material Safety Data Sheets<br />(published by National Occupational Health and Safety Commission)4;<br />· European Union and the International Labour Organisation formats, as described in the<br />MSDS national code of practice;<br />· an MSDS that has been prepared under corresponding legislation in another Australian<br />jurisdiction that has substantially the same data set requirements as these Regulations.<br />4 At the time of publication, the National Code of Practice for the Preparation of Material Safety Data<br />Sheets was being revised to apply to the production of MSDS as required under the National Standard<br />for the Storage and Handling of Dangerous Goods (2000).<br />8<br />Note that the above formats may not cover all the items prescribed in the Regulations. If you<br />base your MSDS on any of those formats, you must ensure that it includes all the prescribed<br />items.<br />If you are using an MSDS prepared overseas, include the relevant Australian information, for<br />example, supplier contact details and any relevant exposure standard.<br />12.2 Reviewing and revising MSDS<br />The MSDS should reflect the current state of knowledge about the dangerous goods. You are<br />required to review an MSDS as often as necessary to ensure the information remains accurate<br />and current. For example, the MSDS would need to be reviewed whenever there is a change<br />in the formulation of a dangerous goods or when new information on the hazardous properties<br />or the health effects of the dangerous goods or one of its ingredients becomes available.<br />In any event, you must ensure the MSDS is reviewed no later than five years after the last date<br />of review. If a review reveals that the MSDS does not contain accurate or current information,<br />it must be revised. After any review or revision, the MSDS must be reissued with the review<br />date.<br />12.3 Providing a current MSDS<br />You must provide a copy of the current MSDS on or before the first occasion that dangerous<br />goods are supplied for use. The MSDS must be provided to any person to whom the<br />dangerous goods are supplied for use and, on request, to any occupier of any premises where<br />those dangerous goods are stored and handled.<br />If you are a retailer, you don’t have to provide an MSDS for:<br />· goods supplied in consumer packages;5<br />· fuel supplied to a vehicle; or<br />· Class 2 dangerous goods (gases) supplied in a container provided by the purchaser.<br />If you retail dangerous goods in consumer packages, you may choose to act by arrangement<br />with your suppliers to distribute MSDS. This would be particularly useful for trade sale<br />outlets.<br />5 A “consumer package” means a container of a net capacity that is readily available through retail outlets<br />for household consumption or consumption by an occasional user. It is a package that a manufacturer or<br />supplier has identified as suitable for use in all market sectors.<br />The inner packaging quantities cited in table 1.1 and 1.2 of the ADG Code would all fall within the<br />commonly understood meaning of consumer package but do not restrict the application of the term.<br />Examples of consumer packages are:<br />· “pool chemicals’ such as granulated chlorine (class 5.1) – widely available in packages having a net<br />quantity of up to 10 kilograms;<br />· sodium hypochlorite solutions (class 8 PG II) – when marketed as a “pool chemical’ the containers<br />can have a capacity of up to 20 litres;<br />· ammonium nitrate fertilisers (class 9), which are widely available in a net quantity up to 25 kilograms.<br />9<br />There is no need to include an MSDS with every delivery. If the MSDS is reviewed, a copy<br />must be provided when the dangerous goods are next supplied, and to any occupier on<br />request. There is no requirement to send a copy of the revised MSDS to all previous<br />purchasers of the dangerous goods.<br />12.4 Provision of other information<br />As a supplier, you must provide any other information that you have been provided regarding<br />the safe use of the dangerous goods. Relevant information may include, but is not limited to,<br />the following:<br />· summary reports produced under the Commonwealth Industrial Chemicals (Notification<br />and Assessment) Act 1989; and<br />· where it is available, specific information relating to the conditions for safe use,compatibility and chemical stability under particular circumstances.shahzadhttp://www.blogger.com/profile/01364507074991292353noreply@blogger.comtag:blogger.com,1999:blog-7305327264533069235.post-44908535376511961712009-06-16T21:11:00.000-07:002009-06-19T21:27:01.022-07:00INTRODUCTION dangerous goods and Dangerous Goods Act1. What are dangerous goods?<br />Dangerous goods are substances that may be corrosive, flammable, explosive, spontaneously<br />combustible, toxic, oxidising, or water-reactive. These goods can be deadly and can seriously<br />damage property and the environment. Therefore, it’s important that they are stored and<br />handled safely.<br />You should read this Code if you manufacture, supply, store or handle dangerous goods. The<br />Code will help you meet your duties under the Dangerous Goods (Storage and Handling)<br />Regulations 2000 to ensure that dangerous goods are stored and handled safely.<br />If you are a health and safety representative or an employee who works with dangerous<br />goods, you may also find this Code useful.<br />2. Which dangerous goods are covered by this Code?<br />The following table (Figure 1) summarises the dangerous goods covered by the Regulations<br />and therefore this Code.<br />Type of Goods Description Reference for<br />classification<br />Dangerous Goods<br />Class 2 Gases<br />2.1 Flammable gases<br />2.2 Non-flammable, non-toxic gases<br />2.3 Toxic gases<br />Class 3 Flammable liquid<br />Class 4 Flammable solids etc.<br />4.1 Flammable solids; self-reactive and related substances;<br />and desensitised explosives<br />4.2 Substances liable to spontaneous combustion<br />4.3 Substances that in contact with water emit flammable<br />gases<br />Class 5 Oxidising substances, organic peroxides<br />5.1 Oxidising substances<br />5.2 Organic peroxides<br />Class 6.1 Toxic substances<br />ADG Code<br />Class 8 Corrosive substances<br />Class 9 Miscellaneous dangerous goods and articles<br />Goods too dangerous to<br />be transported<br />Goods listed in Appendix 5 of the ADG Code and goods<br />determined to be so in accordance with reg 1.18(g) of<br />the Road Transport Reform (DG) Regulations 1997.<br />ADG Code & order<br />C1 Combustible liquid A liquid other than a flammable liquid that has a<br />flashpoint between 61C < 150°C, and a fire point less<br />than its boiling point.<br />AS 1940<br />The storage and<br />handling of flammable<br />and combustible liquids<br />Figure 1: Types of goods covered by the Code of Practice<br />2<br />3. Which dangerous goods are not covered by this Code?<br />The Regulations and this Code do not apply to:<br />· dangerous goods which are explosives (including dangerous goods of Class 1); or<br />· dangerous goods of classes 6.2 and 7 as defined in the ADG Code;1 or<br />· dangerous goods while they are used in the manufacture of explosives in accordance with<br />Part 3 of the Dangerous Goods (Explosives) Regulations 2000; or<br />· dangerous goods which are batteries while they are in use; or<br />· dangerous goods in a fuel container which is fitted to a vehicle or boat; or<br />· dangerous goods in the form an appliance or equipment that forms part of a vehicle or boat<br />and is necessary for its operation; or<br />· dangerous goods in the fuel container of a domestic or portable fuel burning appliance; or<br />· combustible liquids unless they are C1 combustible liquids; or<br />· dangerous goods in portable firefighting or medical equipment deployed for use at the<br />premises; or<br />· asbestos designated by UN 2212 or UN 2509.<br />Dangerous goods at non-workplaces<br />Once any of the thresholds specified in regulation 106(1)(k) are exceeded, all the relevant<br />provisions of the Regulations apply at the premises, and as a consequence, this Code applies.<br />The Regulations and Code do not cover the following dangerous goods if they are at premises<br />that are not a workplace:<br />· compressed gas of Class 2.1, Class 2.2 or compressed oxygen each in aggregate quantities<br />of less than 50 litres forming part of a welding set or used or intended to be used with a<br />portable flame torch; or<br />· compressed oxygen or air used or intended to be used for medical purposes; or<br />· dangerous goods of Class 3 in an aggregate quantity of less than 250 litres; or<br />· pool chlorine in an aggregate quantity of not more than 100kg; or<br />· sodium hypochlorite designated by UN 1791 in an aggregate quantity of not more than 100<br />litres; or<br />· Class 9 dangerous goods in an aggregate quantity of not more that 100 kg; or<br />· dangerous goods of Packing Group I in an aggregate quantity of not more than 5 kg; or<br />· combustible liquids in an aggregate quantity of not more than 1,000 litres; or<br />· any other dangerous goods (not including dangerous goods of Class 2.3) in an aggregate<br />quantity of not more than 100 kilograms.<br />1 The ADG Code means the document known as the Australian Code for the Transport of Dangerous<br />Goods by Road and Rail (Sixth edition or a later prescribed edition), as amended from time to time.<br />The Dangerous Goods Act 1985 incorporates the ADG Code for definitional purposes and that Code is<br />directly incorporated into the Commonwealth Road Transport Reform (Dangerous Goods) Regulations<br />1997. The latter Regulations have the force of Victorian law by virtue of the operation of the Victorian<br />Road Transport (Dangerous Goods) Act 1995, which brings the Commonwealth Road Transport<br />(Dangerous Goods) Act into state law. The effect of this legislative framework is to make the<br />requirements contained in the ADG Code mandatory.<br />3<br />4. What is the difference between ‘dangerous goods’ and<br />‘hazardous substances’?<br />Don’t confuse dangerous goods with hazardous substances – they are classified according to<br />different criteria. Dangerous goods are classified on the basis of immediate physical or<br />chemical effects, such as fire, explosion, corrosion and poisoning, affecting property, the<br />environment or people, while hazardous substances are classified only on the basis of health<br />effects (whether they be immediate or long-term).<br />Dangerous goods and hazardous substances are covered by separate legislation, each focusing<br />on controlling the different risks described above. Since many hazardous substances are also<br />classified as dangerous goods, the requirements of both pieces of legislation will apply in<br />these cases. Each piece of legislation complements the other, effectively ensuring the<br />comprehensive control of all risks.<br />5. Relationship with other regulations<br />There are a number of regulations made under the Dangerous Goods Act 1985, Road<br />Transport (Dangerous Goods) Act 1995 and the Occupational Health and Safety Act<br />1985 which have some relationship with the Storage and Handling Regulations. Appendix 2<br />provides a detailed summary of these relationships.<br />6. Competencies of people carrying out duties<br />You have a responsibility to ensure that people carrying out duties under the Regulations on<br />your behalf have the appropriate competencies to enable them to perform tasks correctly. The<br />competencies may be acquired through training, education or experience or through a<br />combination of these.shahzadhttp://www.blogger.com/profile/01364507074991292353noreply@blogger.comtag:blogger.com,1999:blog-7305327264533069235.post-6766570994606552462009-06-11T22:35:00.000-07:002009-06-11T22:36:47.961-07:00particularly sensitive and fluid area at present and may present some7. <strong>Production and packing runs</strong><br />Posts with authority to start a production run should be clearly stated and<br />understood by all company employees<br />There should be agreed procedures for taking cd raw material to production<br />suite, taking into account SOPs on deliveries/secure storage etc<br />There should be agreed reconciliation procedures to accord with GMP<br />If cd material is ever left unattended outside the cd store during production<br />process there should be agreed physical security for this<br />There should be reasonably secure facilities for storage of rejected<br />amps/tabs or other containers on the production/packing lines<br />At the end of each working day any waste or leftover cd material should be<br />secured and removed to the cd store<br />All finished cd packs should be removed to the cd store at the end of each<br />working day<br />There should be agreed procedures (with authorised witness?) for<br />destruction of waste material<br />Finished packs should be reconciled with raw/base material used, in<br />accordance with GMP<br />8. Emergency procedures<br />These should cover fire, flood, illness and attack<br />People who work inside the cd store, for whatever periods, should<br />understand all emergency procedures<br />Normal advice in hostage situations is to do whatever the hostage taker<br />asks. We have sought Police guidance as to whether hostages need to bear<br />anything else in mind<br />Panic buttons/hidden alarms should normally not be used if under armed<br />threat.<br />9. Staff searches<br />Staff searches should be undertaken by authorised personnel and must be<br />regular but random (except in special circumstances)<br />All staff, visitors and contractors must be warned that they will be required to<br />empty their pockets immediately on leaving the cd store<br />A record of search will be signed by both the searcher and the searchee and<br />stored in a secure place<br />The checking of all documentation will take place outside the cd store prior to<br />entry<br />10 CCTV monitoring and tape management<br />During weekdays cctv tapes will be changed every 24 hours. At the weekend<br />the tapes will be changed every 72 hours (to be varied by agreement) A<br />check should be made at each change that the timer on the recorder is set<br />correctly.<br />The licensee will wish to consider who, and how often reference to activity on<br />security televisions screens is monitored.<br />During weekdays the previous day’s tape(s) will be reviewed. At weekends<br />the tapes will be reviewed after 72 hours. Any abnormality should be reported<br />to the Security Manager/Officer or Ops Manager<br />Used tapes should be dated and archived in a secure cabinet somewhere on<br />site<br />Each tape should be kept for a period of at least 31 days before being reused<br />When a tape reaches the end of its useful life it should be wiped clean and<br />destroyed after not less than 31 days from when it was last used<br />11. Alarm activations<br />Fire Alarm<br />Upon activation of the fire alarm a siren will sound (?throughout the<br />warehouse)<br />All staff must then, unless otherwise notified, congregate at the authorised<br />meeting points<br />The cd store should be locked shut before cd staff proceed to the meeting<br />point provided that this is not a threat to personal safety<br />The fire alarm should, if applicable, notify the Intruder Alarm Monitoring<br />Station or CCTV Monitoring Station. Procedures should be in place to notify<br />the fire brigade or the police, as appropriate<br />Intruder Alarms<br />In the event of an activation the Intruder Alarm Monitoring Station (IAMS)<br />should be alerted automatically (whistles and bells optional)<br />If appropriate, the IAMS will contact the CCTV Monitoring Station (CCTVMS)<br />for assistance in establishing whether there is an identifiable threat. If a threat<br />can be identified the CCTVMS should call the police<br />In the absence of a CCTVMS the IAMS should notify the appropriate<br />responsible person within the company and accompany him/her onto site.<br />In the event of any identified threat to staff, the police should be called by<br />dialling 999.<br />Personal attack alarms (where used)<br />Arrangements for response to these will vary and should be checked with the<br />company’s security personnel<br />One system in use is that upon activation a message is relayed automatically<br />to the IAMS who immediately call the police, the company’s responsible<br />person and the CCTVMS (where applicable)<br />12. Security Officer’s/Manager’s responsibilities<br /> Assuming that the company in question has a security officer, duties will vary<br />considerably between different locations. The duties below are some that relate<br />to one of our licensees and are offered as an example<br />To ensure that all those dealing with cd’s are able to identify them (eg a list of<br />cd products is available in Goods In)<br />To ensure that members of staff handling cd’s are well known to the company<br />and considered appropriate persons for handling such products<br />To ensure that, once received, all cd’s are taken immediately to a cd store<br />after visual checking (bulk supplies) or detailed verification (This may not<br />always be appropriate)<br />To make immediate enquiries with suppliers and/or carriers into<br />shortages/overages/damages/delays in cd deliveries<br />To report any thefts/losses to Home Office Drugs Inspectorate in accordance<br />with the terms of their licence<br />To ensure that, under no circumstances, are staff, visitors or contractors<br />allowed to take bags, cases etc into the cd store.<br />To direct staff/visitor searches in accordance with SOP on searches<br />To ensure that any alarm system covering cd’s is in full working order and<br />that police/security company response to activations is commensurate with<br />the risk<br />To ensure that the SOP on CCTV procedures is complied with<br />To ensure that the SOP on key security is complied with<br />To ensure that any references provided by cd store personnel are taken up<br />and are satisfactory<br />To arrange destruction of damaged or out of date cd’s with an authorised<br />witness present.<br />The witness may be the HO Inspector or a person within the company<br />authorised to witness destructions under The Misuse of Drugs Regulations<br />2001.<br />A method of destruction will need to be agreed in advance with the HO<br />Inspector and may range from adulteration of small amounts to incineration<br />for larger ones.<br />A written record in an agreed format must be produced of materials<br />destroyed.<br />To amend cd stock records as necessary (?with HO approval)<br />To ensure that cd stock checks are carried out according to company policy<br />13. CD Operatives responsibilities<br /> This may also vary according to licensed premises but not as much as security<br />personnel<br />Immediate checking of all incoming against supplier’s delivery note to ensure<br />correct goods in satisfactory condition have been received<br />To bring to the immediate attention of Security Manager/Officer or Ops<br />Manager any discrepancy or signs of tampering found in a delivery or any<br />delivery of cd’s that has not been ordered.<br />Immediately (or at least within 24 hours) update the records system(s)<br />Undertake stock checks in accordance with company policy<br />14. Client/customer responsibilities<br />To ensure cd’s are not delivered outside agreed procedures<br />In the case of large or particularly sensitive cd deliveries, to advise<br />Security Officer/Manager of date, time and means of delivery<br />To ensure that delivery is as per order when it is dispatchedshahzadhttp://www.blogger.com/profile/01364507074991292353noreply@blogger.comtag:blogger.com,1999:blog-7305327264533069235.post-82655288686501144462009-06-11T22:33:00.000-07:002009-06-11T22:35:18.055-07:00Guidelines for producers and other licensees<strong>Purpose</strong> of SOP and its status (e.g. would failure to follow it be a disciplinary<br />offence?) should be stated at the top of the document.<br />Purposes may include procedures for delivery, dispatch, handling and storage of<br />cd’s. During production storage should include in process material. May also<br />include recruitment policy (cd store and other sensitive areas) staff searches, cctv<br />monitoring as well as tape management, key access and procedures, entry/exit<br />procedures to main warehouse and cd store, alarm activations, hostage<br />situations.<br /> The scope of the particular SOP should be stated (eg covers all matters relating<br />to cd’s)<br /> Some procedures may be subject to separate SOPs of their own eg. booking in,<br />despatch, stock checks & QA sampling. There should also be a separate SOP<br />covering emergency procedures such as fire, unauthorised entry, personal attack<br />etc.<br /> It should be clearly stated who within the company has overall responsibility for<br />cd’s and who for operational matters (may be the same person) The post having<br />responsibility for each must be clearly stated.<br /> If there is a security officer/manager or other security personnel on site their<br />roles, duties and responsibilities must be clearly defined.<br />1. Orders and arrangements for receipt of cd’s (to be agreed with suppliers)<br />It should be clearly stated who may place orders for cd raw materials/finished<br />goods & under what authority<br />There should be an agreed form(at) for ordering, preferably a single cd order<br />form<br />A second named postholder should check/authorise orders<br />Manual alterations to printed orders should not be allowed, except in the most<br />stringent of circumstances<br />There must be a proper record kept of orders (paper and/or computer)<br />Records of orders and confirmation of receipt of goods by customers should<br />be checked or audited at agreed intervals<br />In the case of all or significant orders, suppliers should be made aware of<br />identity of personnel who may order cd’s and the form of the orders<br />An agreement should be made with suppliers over delivery arrangements for<br />cd’s and this should be adhered to unless revised<br />Receiving company to know details of delivery i.e. time, vehicle, personnel &<br />contents (for large deliveries particularly)<br />2. Acceptance of deliveries & procedures on receipt<br />There should be agreed procedure for receipt of deliveries of cd raw material<br />& delivery vehicles brought on to site (eg checking drivers’ bona fides,<br />unloading vehicles behind closed doors by authorised personnel only).<br />There should be agreed procedures (including physical security) for returns<br />and deliveries/dispatches of other cd’s (eg through goods in not Reception)<br />There should be a visual check made of goods before acceptance and<br />before delivery is signed for<br />Drums/containers must be check weighed at earliest opportunity, gross<br />weights recorded and checked against tare record.<br />There should be an agreed procedure for delivering goods to secure storage<br />If discrepancies are discovered there must be a clear and agreed procedure<br />for reporting these to responsible person within the company, to the supplier<br />& to the Home Office Drugs Inspectorate within a specified time.<br />3. Procedures for accepting orders and cd dispatch<br />The bona fides and/or licensed status of customers must be confirmed<br />before any order for cd’s is accepted. The latter is particularly important for<br />suppliers of Schedule 1 (para 1b &1c compounds) cd’s<br />Cd’s should remain in the cd store or other agreed secure receptacle until<br />ready for dispatch<br />Cd’s should not be released to a delivery driver except in accordance with an<br />official order form<br />There should be a separate SOP for storage and delivery of cd’s from<br />delivery vehicle<br />This SOP should include clear instruction that deliveries should be signed for<br />by authorised person before being left<br />4. QC<br />SOP/agreed procedure for who has authority to break seals, take QC<br />samples and re-seal containers. Certain QC staff may need to be on list of<br />personnel authorised to enter cd store<br />Removal of sampling material by QC staff should be undertaken in the<br />presence of another member of that section<br />Samples should be recorded in an agreed manner (record kept in cd store &<br />QC lab<br />QC should have its own SOPs covering all their work including secure<br />storage facilities<br />QC will be involved at other stages, including production. SOPs should take<br />account of this. All QC practices will be covered by GLP.<br />5. CD Store (may be subject to separate SOP covering all aspects such as entry/exit<br />and alarm procedures)<br />If there is a cd store, those having access to it should be listed in an annex to<br />the SOP (not necessarily including managers). Access should be strictly<br />limited to essential personnel only<br />Certain unauthorised persons (visitors/contractors/HO inspectors) may be<br />allowed access but must be accompanied by an authorised person, who<br />should not leave the visitor unsupervised at any time<br />Those allowed accompanied access (HO inspectors/police etc) should be<br />listed and the circumstances under which they are allowed access should be<br />stated. Warrant cards/ID must be shown where appropriate.<br />Under no circumstances should staff, visitors, or contractors be allowed to<br />take bags, cases etc into the cd store<br />Persons authorised to hold keys to cd store should be listed in separate<br />annex along with secure location for keys when not in use<br />There should be a set procedure for handing over keys and returning same<br />The Cd Store alarm(s) should always be set when the store is unoccupied<br />It may be appropriate, for high security stores, to record entries (time, date &<br />personnel) to the store<br />Upon entry to the cd store the alarm must be turned off immediately<br />The circumstances under which the cd store may be opened and remain<br />opened with alarms unset should be set out<br />If there is a grill or day gate the circumstances under which it may be open<br />should be set out<br />If cctv is installed covering cd store it should be switched on at all times<br />It must be clearly set out who has responsibility for checking cctv monitors<br />Outside contact and procedures in emergency situations must be clearly<br />understood by all concerned<br />6. Recruitment policy<br />Licensees may wish to set up or take advantage of local arrangements with<br />police to vet prospective employees, particularly those working in sensitive<br />areas. Such employees may be asked to obtain a personal CRO check from<br />the police<br />All references from prospective employees should be taken up by Security<br />Officer/Manager or other manager<br />Personnel selected for cd store duties should have been with company for a<br />minimum period of time (12 months or more)<br />All new recruits should be asked to sign an agreement authorising personal<br />searches and searches of their means of transport (where applicable) by<br />approved company personnel (see also para 9). The company may wish to<br />consider the use of random drug testing for employees working with<br />controlled drugs<br />Particular care needs to be taken in the recruitment and use of agency staff.<br />The licensee will wish to satisfy themselves of the agency’s bona fides, as<br />well as its procedures for vetting potential candidates.shahzadhttp://www.blogger.com/profile/01364507074991292353noreply@blogger.comtag:blogger.com,1999:blog-7305327264533069235.post-46838686090779880212009-06-11T21:56:00.000-07:002009-06-11T22:02:24.076-07:00Pharmaceutical recordkeeping system with labelling for manufacturing raw materialsA system for recordkeeping, comprising assigning a bar code label to material to be processed including information identifying the material and successively moving the material into a plurality of processing stations. At each station the bar code label is read, a second bar code label including information relating to a processing operation is assigned to the material, the second bar code label is read, a processing operation is performed in accordance with the second bar code label and a third bar code label is assigned to the material including information corresponding to results of the processing operation. The information from the first, second and third labels are stored in a main storage device.<br />This application is a continuation-in-part application of U.S.<br />Claims:<br />What is claimed is:1. A method for recordkeeping, comprising the steps of:<br />receiving material to be processed and assigning a machine readable first data record holder to the material to be processed, including a first data record comprising information identifying the material;<br />reading the first data record holder at a quarantine station;<br />assigning a machine readable second data record at the quarantine station to samples from the material to be processed including a second data record comprising the electronic signature of an operator taking the samples and information relating to the sample requirements; and<br />reading the second data record holder at the quarantine station;<br />moving the material to be processed into a processing station and assigning a third data record holder to the material including a third data record comprising the electronic signature of an operator performing a processing operation and information relating to the results of the processing operation; and<br />storing the first, second and third data records in a main data storage device.<br />2. The method according to claim 1, wherein each step of assigning comprises printing a bar code label and attaching the label to the material. 3. The method according to claim 2, wherein each step of reading comprises scanning a bar code label with a bar code scanner. 4. The method according to claim 1, wherein each step of assigning comprises providing a portable memory device and attaching the device to the material. 5. The method according to claim 1, wherein the second and third data records further comprise a time code. 6. The method according to claim 5, wherein the step of storing comprises generating a checkcode for each data record and storing both in the main storage device. 7. The method according to claim 6, wherein the checkcode is generated by combining data bits relating to the electronic signature, data bits relating to the time code and a checksum of the data record.<br />Description:<br /><strong>BACKGROUND OF THE INVENTION</strong><br />The present invention relates to a system for assuring compliance with procedures in ongoing production processes and in particular a pharmaceutical recordkeeping system.<br />Currently, many manufacturing processes are regulated by government and state agencies which set forth procedures with which manufacturers must comply in order to obtain regulatory approval for their products. For example, pharmaceutical manufacturing processes must comply with NDA/ANDA procedures and must accumulate permanent raw material and manufacturing batch processing records in compliance with FDA regulations.<br />While manufacturers have complied with these rules and regulations by manual recordkeeping, there has been a need for an automated system which can adapt to the specific needs of each manufacturer while maintaining compliance with manufacturing procedures and recordkeeping requirements.<br /><strong>SUMMARY OF THE INVENTION</strong><br />The main object of the present invention is to provide an automated system for assuring compliance and permanent records of ongoing production processes.<br />Another object of the present invention is to improve productivity by reducing paperwork, automating data acquisition, improving materials flow and by authorizing operators under controlled and secure access conditions.<br />The system according to the present invention can be implemented into a batch processing oriented manufacturing operation for pharmaceutical manufacturing, bulk pharmaceutical chemical formulation, food and beverage processing, consumer package goods manufacture, clinical laboratory diagnostics reagent production and medical device manufacturing.<br />In accordance with the invention, data can be input via keyboard and mouse, touch screens, keypad data entry, wireless and plug-in bar code scanners and terminals and the like.<br />One feature of the present invention is the use of an electronic signature to control employee security access. Each operator is identified to the system by a name code or bar code and a password. The combination of either the name code and password or the bar code and password represents the electronic signature of the operator.<br />In accordance with the method of the present invention, sample inspections and tests insure that only those materials and product batches which meet quality standards are processed into finished product and shipped to customers. The method automatically requests the necessary samples, inspections and tests and maintains the status of the results in a database. The system will only allow those materials and product batches which have met these criteria to be processed further.<br />All data associated with a particular product batch, including all materials used in the process, are automatically assembled into a complete batch record for review prior to product distribution. The records may be reviewed in their completed state or in the sequence that the data and verification were recorded.<br />The system also utilizes redundant storage of records to insure data integrity. For example, during the performance of a blending step in the manufacturing process of a particular product, a sequential logging file would record the identification of the performing operator, the batch record file and the facility and equipment file with every operation time and date stamped. The data would be recorded in a redundant server as each step was completed to prevent data loss should a piece of workstation hardware fail.<br />Furthermore, each data entry in the system generates a unique check code. The check code permanently binds an electronic signature to the event. As part of the system, background programs check the recorded data and the check codes and these check codes not only verify that the data stored and retrieved is identical, but it also looks for inconsistent or unauthorized modifications of the records. Should a discrepancy be detected, it will be reported to a system manager.<br />All data recorded in the system can be archived on unalterable compact disk write-once read-many media. The timing of the periodic archiving is controlled by the system and types of data to be archived include sequential event logging, completed material lot histories, completed batch records and document revision histories.<br />Under the control of the system, certain operators can be limited to using one particular workstation. Each significant event performed on the system is recorded in the database with a date and time stamp and the identification electronic signature of the individual performing the event.<br />The present invention makes full use of bar coded labels, with comprehensive tracking and verification of materials from receipt, through inprocessed batches, to packaged product and shipping. Movements and status are monitored in accordance with the present invention and controlled. Unique material lot numbers are generated and bar coded labels are printed to identify each container. Prompts and bar coded labels are provided for material sampling, sample inspections and tests in quality control review accepts or rejects material and the location of material is established with bar coded warehouse rack and aisle designations.<br />Unique batch numbers are generated on bar code labels and withdrawal and dispensing of materials are prompted in accordance with released batch production control records. Materials are automatically allocated to each batch on a first-in/first-out basis or by specific allocation through management intervention. Prompts and bar coded labels provide for dispense material and batch identification, with automatic material inventory level update. There is automatic reconciliation of material lot weight or measures after depletion and bar coded labels are generated for all inprocess product and sample containers.<br />The scanning of container bar code labels provides the system of the present invention with the ability to track and verify the materials and batches by their lot and batch numbers. The system alerts operators if they attempt to move or use materials incorrectly. Wireless or plug-in palm top bar code scanners and terminals allow this verification to be implemented in larger areas, such as a warehouse, and the reconciliation of material lot total weights and measures with specific attention to product labels and printed containers is performed by the system.<br />The system also handles material dispensing and recipe tracking. Material is delivered to local inventory and, after reading or generating the bar coded data describing the materials, the dispensing process is initiated. The system acts to insure that equipment, room, personnel and container rules are observed. As each step is undertaken, the system can verify that the recipe and its constraints are not violated.<br />The system verifies that material delivered to local inventory with potency data is in accordance with the equation relating weight or volume to potency. The system can alert the operator if materials do not meet required tolerances or if dispensed material does not fall within the allowed weight ranges. The system can provide multiple dispensing of a single ingredient for a single batch where the ingredient is mixed in different stages.<br />The system identifies dispensed ingredients and quality control samples when required with bar codes and specifies quarantine or acceptance. Material to be returned to the warehouse, local inventory, special storage, waste or which has outlived its shelf life is routed as required.<br />The system can only proceed once prescribed data, personnel identification or electronic signature entries, as defined by management have been made at the time of completion of a process step. Alerts can be provided by the system when incorrect responses are received, with the option to require a second party intervention to correct an entry. Thus the system insures data integrity and compliance with defined procedures.<br />These and other objects of the present invention are also achieved in accordance with the present invention by the use of a system comprising portable memory devices (PMD's) and associated stations having read/write equipment to document process requirements and permanently record process data, all under the control of a main processor. The PMD's are secure, serialized, non-alterable electronic tags which travel with the materials or manufacturing batches. Data is permanently written into the "write once read many" memory in the PMD. An example of a device which is useful for this purpose is the Fujitsu MB98A6070, MB98A6080, MB98A6090 and MB98A6100 one time programmable read only memory card. Once data has been written into the PMD, the data cannot be altered, but, can be read as many times as necessary thereafter. Additional data can be sequentially added to the PMD, up to the memory capacity of the PMD.<br />In accordance with the invention, master production and control procedures and requirements are entered into a PMD when manufacturing is initiated. The identification and process record data required by the FDA, is written into the PMD's on a real time basis for comparison with the process requirements and the permanent archiving of actual process data. The data is written into and retrieved from the PMD's using stationary or handheld read/write equipment at each process station. There are two different types of PMD's available. One type uses a radio frequency or electromagnetic signal to communicate with the PMD during the read/write functions. The other type of PMD plugs directly into the read/write equipment, making a direct electrical connection for communications. Management of the recorded data is controlled by a main processor linked to each station by a bus or network connection. The main processor controls the security and accessibility to the data in each PMD, performs data comparisons for verification of materials, products, equipment, test samples and controlled parameters contained within each PMD to provide alerts in the event of errors. The main processor provides an index of the PMD's and can also assemble and format a printout of the stored data for review and evaluation at a later time.<br />In a particularly advantageous commercial embodiment of the present invention, a pharmaceutical manufacturing system can be implemented wherein individual PMD's are assigned to each lot of raw material upon receipt by the manufacturer. The specific material identification, receipt date, weight or measure, unique lot number and a delineation of all sample test requirements for final acceptance are written into the PMD for each lot. When samples are withdrawn from the material lot for acceptance tests, intermediary PMD's are assigned to each sample to assure correlation of the samples to the material in quarantine. The specific material identification and test requirements are read from the raw material PMD and written into the sample PMD. The sample PMD then travels with the sample of material through the completion of the testing. Test pass or fail notations are written into the sample PMD by the test laboratory at the specific station and the sample PMD is returned to the raw material quarantine area for correlation with the original material PMD through a dual read and compare routine. Following this routine, the test results are read from the sample PMD and written into the correct raw material PMD. The sample PMD can then be reused for the sampling of other raw material, or archived when the memory capacity has been exhausted.<br />When all material acceptance requirements have been satisfied, the raw material PMD is again written into to indicate that the material is accepted and the raw material, together with its raw material PMD, is moved together out of quarantine and into usable stock.<br />The system is also used in the dispensing of raw materials for the manufacturing processes. Manufacturing components are requested from the raw material in usable stock via a PMD containing the identification of the manufacturing batch and the specifics of the requested raw material. The application of a dual read and compare routine to the requesting manufacturing component PMD and the raw material PMD assures positive correlation between the requested material and the actual material that is dispensed.<br />The specific manufacturing batch identification and dispensed weight or measure are written into the raw material PMD each time material is dispensed or issued. Likewise, the raw material lot identification and dispensed weight or measure are written into the manufacturing component PMD for return to the manufacturing process along with the dispensed material.<br />Other information is added to the PMD's at various times during the process and annotations of the date and time, the identification of the performing and verifying individuals and traceable references to any problem investigations, represent some of the additional data included in the PMD.<br />When the lot of raw material has been exhausted, reconciliation of the dispensed versus the total received weight or measure may be performed since the raw material PMD contains a complete and unalterable history of the specific lot of raw material. The raw material PMD is then archived for later retrieval of data for the duration of the required FDA retention period. If sufficient unused memory capacity remains, the PMD may be used for additional lots of raw material before being retired to the archives.<br />In manufacturing, two PMD's are assigned to each manufacturing batch at the time of production authorization. One PMD, the manufacturing PMD, is formatted with the specific product and batch identification, along with a reproduction of the complete master process and control requirements for the product. The second PMD, the component PMD, is formatted with some of the same information, however, with specific annotations with all of the material components required during the manufacturing process.<br />As the manufacturing process is implemented, actual process information is recording on the manufacturing PMD. This information includes the equipment used, the yields obtained and compliance with specific process limitations such as time, temperature and speed. Comparison routines verify the actual data with the established master production and control requirements or limits and can alert the operator to the need to resolve any discrepancies.<br />As described with regard to the raw material, intermediary samples PMD's can be used for the manufacturing in process sample tests. The sampling requirements are written from the manufacturing PMD into the sample PMD when the sample is required. Later, the results of the sample testing are written from the sample PMD into the manufacturing PMD upon successful completion of each test.<br />The associated component PMD is used and actually moves between the manufacturing process and the stock room, to verify the dispensing of the required material. As with the correlation of the requested and dispensed raw material heretofore described, the component PMD also provides positive assurance that the correct material is used in the manufacturing process. The dual read and compare routine is applied to both the component and manufacturing PMD's upon return of the dispensed material from the stock room and before introduction of the raw material into the manufacturing process.<br />Other required information can also be added to the manufacturing and component PMD's at various times during the process, including verifications to proceed and final acceptance of the product by quality assurance.<br />Assuming bulk product is completed and held for later packaging, two new PMD's are assigned to each packaging lot. These PMD's are used in the same manner as the manufacturing and component PMD's to control and monitor the packaging process and materials. Product distribution may be added to the packaging PMD as the product is shipped.<br />The bulk manufacturing and packaging PMD's contain a complete unalterable history of the process, including verification of compliance with the requirements of the master production and control record. These PMD's are then archived after depletion of the batch of bulk production and completion of finished product inspections, record reviews and distribution of the packaged products for FDA record review in the future. If sufficient unused memory capacity remains, the manufacturing and packaging PMD's may be used for additional batches before being retired to the archives.<br />Each PMD contains a unique, permanently recorded, serial number in the memory. The additional permanently recorded cross referencing of material lot numbers, manufacturing batch numbers, and the PMD serial numbers in companion PMD's, make it virtually impossible to covertly alter or destroy actual recorded historical data. Therefore, the invention prevents undetected data tampering and an extremely high level of archive data security.<br />Throughout the raw material and manufacturing processing, the PMD data is periodically accessed and stored in a database in the main processor for appropriate analysis. A cross referenced index of the PMD's is established, updated, and maintained in the database of the main processor to facilitate the location of specific archived material or product batch data.<br /><strong>DETAILED DESCRIPTION OF THE INVENTION</strong><br />Referring now to FIGS. 1-5, a preferred embodiment of the present invention is described with reference to a system for producing pharmaceutical products. It is understood by those skilled in the art that the present invention can be adapted to other processes where high levels of security and preventing the tampering of records is required.<br />A main processor 15 is connected to a plurality of stations 1-12 via bus 16. Stations 1-12 interact with a plurality of portable memory devices (PMD's) 21-29 by means of electronic signals or electromagnetic waves. The PMD's 21-29, for example, may have up to 1 mb of storage and can be written into and read out from via electronic signals or electromagnetic waves transmitted from stations 1-12 to PMD's 21-29 and received from PMD's 21-29 at stations 1-12 which are stationary or handheld read/write devices. Examples of PMD's and stations are disclosed in U.S. Pat. Nos. 4,242,663, 4,549,264 and 4,724,427, the disclosures of which are hereby incorporated by reference.<br />The main processor 15 includes a microprocessor and main memory which receives data from stations 1-12 and sends data to stations 1-12 for transmittal to the PMD's 2129. Main processor 15 is preferably a microcomputer having an Intel microprocessor, such as the 80486 or a Macintosh computer based on a Motorola microprocessor.<br />The first stage of a pharmaceutical manufacturing process involves the reception and acceptance of raw material which is to be used to manufacture a product. When raw material is received at station 1, the name and code of the material, as well as the date, weight or measure and vendor of the raw material is entered into the memory of the main processor 15. At that time in step 101, a raw material PMD 21 is assigned to the lot of raw material and is formatted by main processor 15. The raw material PMD has data written into it from a database in main processor 15 in step 102 via station 1 and this information includes the material name and code, the material lot number, the vendor, the acceptance requirements including the sample required, examination and test required, as well as the criteria for the test, the date received, the total weight or measure and reconciliation limits.<br />The lot with the raw material PMD 21 is moved into quarantine at station 2 in step 103 whereupon samples are removed for various acceptance tests in step 104. Each sample has a sample PMD 22 assigned to it. Under the control of the main processor 15, data from the raw material PMD is written into the sample PMD's in step 105 including the material name and code, the material lot number, the sample required, the required tests and criteria, the sample date, the I.D. of the person taking the sample.<br />The samples are moved to station 3 where the tests are conducted in step 106 and each test PMD 22 has data written into it in step 107 reflecting whether or not it passed or failed its particular test, the I.D. of the person making the test and the date of the test.<br />The sample PMD's 22 are then moved back to station 2 whereupon a dual read and compare is performed in step 108 wherein main processor 15 verifies that common data is read from the sample PMD 22 and the raw material PMD 21 specifically relating to the material name and code and the material and lot number. Upon verification, the data relating to the tests are written from the sample PMD into the raw material PMD in step 109 including the sample date, sampling person I.D., whether the test was passed or not, the test person I.D. and test date.<br />Based upon the results of the test, the raw material must either be accepted or rejected. This acceptance or rejection is written into the raw material PMD in steps 110 or 111, as well as the identification of the person making the decision. If the material is rejected, it is kept in quarantine or disposed of in step 111. If the material is accepted, the lot of raw material is placed in usable stock.<br />The manufacturing process uses components of raw materials which have been accepted and placed in usable stock.<br />In the bulk manufacturing process, initially two PMD's are assigned for a product in step 121. The first PMD is a batch manufacturing PMD 24 and the second PMD is a batch component PMD 23. At station 5, the manufacturing PMD 24 is formatted by the main processor 15 which writes into the manufacturing PMD in step 122, product identification including the product name and code, the strength or dosage of the product, the batch size, the batch lot number and the master production and control for the processing including each step of the production, as well as the process requirements for each step. These requirements include the equipment to be used, the process theoretical yield and acceptable tolerances, and process limitations including tolerances on time, temperature and speed. The in-process test requirements including the number of samples required, the tests required, and their criteria are also recorded.<br />The component PMD 23 is formatted by main processor 15 which writes into it in step 123 the product identification and master production and control data including for each step, the material required including the active ingredients identified by material name and code and weight or measure required and the same information for any components of the product being manufactured.<br />When the order is released for production, the date and the electronic signature of the release person is written into the manufacturing PMD and the component PMD.<br />Component PMD 23 is then moved to station 4 where raw material and raw material PMD 21 are located. A dual read and compare is performed in step 124 between the component PMD and the raw material PMD to verify a common material name and code. Upon verification, the material lot number and the acceptance of the material is read from the raw material PMD and written into the component PMD in step 125. The product identification information is read from the component PMD and written into the raw material PMD. Furthermore, the amount of material dispensed is indicated in the raw material PMD so that a reconciliation can be performed in the main processor 15. The main processor, upon determining that the first raw material has been dispensed, will indicate to an operator that another raw material is needed at station 4, and the steps 124 and 125 will be repeated until all of the required materials have been dispensed.<br />The component PMD then returns to station 5 for the first step of the manufacturing process. Before the first process step is performed, a dual read and compare operation is performed in step 126 between the component PMD and the manufacturing PMD to verify that common product identification and common master production and control data are contained on the two PMD's.<br />At this time, various process steps are performed to manufacture the product. For each process step, the dual read and compare operation is performed as further material components are added. Moreover, data is written into the manufacturing PMD for each process step including the fact that material has been dispensed and verified, the equipment that is used, the start time and date, actual yield and whether the yield was within the limits, completion time and whether the completion time was within the limits, the process operator I.D., and the supervisor I.D.<br />After the process step, the batch is moved to station 6 in step 127 where samples are withdrawn and sample PMD's 25 are provided for each sample. Data is read from the manufacturing PMD and written into the sample PMD in step 128 including product identification, the step number, the sample required, the test required and the criteria.<br />The tests are performed at station 7 in step 129 and data is written into each sample PMD in step 130 including the sample date, the I.D. of the person taking the sample, whether or not the test was passed, the I.D. of the person administering the test and the date of the test.<br />The sample PMD is returned to station 6 where a dual read and compare is performed in step 131 with the manufacturing PMD to verify that common data relating to the product identification and the master production and control is present. Upon verification, data relating to the sample and test is read from the sample PMD and written into the manufacturing PMD in step 132. Based upon the test data, the sample is noted as having been completed and accepted and the acceptance and the I.D. of the person making this acceptance is written into the manufacturing PMD in step 133.<br />The product batch, manufacturing PMD, and component PMD are then moved to station 5 for the next step in the process and steps 124-133 are repeated for each process step.<br />In the last step of the manufacturing process, the component PMD can be used to obtain capsules for encapsulating the finished product. The component PMD would include for this last step the capsule requirements and the material would be encapsulated at station 5. The same testing can be performed at station 6 and station 7 before the finished bulk product is finally approved and accepted for packaging in step 134.<br />At this time, the product packaging PMD 26, and packaging component PMD 27, are assigned in step 141. These new PMD's have similar purposes to the manufacturing PMD 24, and the manufacturing component PMD 23, described earlier. The main processor 15 formats the product packaging PMD 26 at station 8 and writes data therein in step 142 including product identification, product name and code, strength and dosage, packaging lot number, package quantity, content quantity, packaging requirements including containers, seals, and labeling requirements, and the final product sampling test requirements. The packaging component PMD 27 is formatted in step 143 with the same product identification information and the specific requirements for packaging materials, labels, and the bulk manufactured product weight or measure. When the packaging process lot is released, this fact is written into the product packaging and packaging component PMD's including the date and electronic signature of the person making the release.<br />The packaging component PMD 27 moves between stations 8 and 9, as in the case of the manufacturing component PMD which moved between stations 4 and 5, to obtain the accepted bulk product and packaging materials form stock. First, the packaging component PMD 27 is correlated with the bulk manufacturing PMD 24 using the dual read and compare routine at station 9. The manufacturing batch identification is read from the manufacturing PMD and written into the packaging component PMD, and the packaging lot identification is read from the packaging component PMD and written into the manufacturing PMD.<br />The packaging component PMD 27 is used again in step 145 to correlate with the packaging material PMD 28 at station 9 to verify the correct materials and transfer the identification information between the PMD's. The packaging material PMD is similar to the raw material PMD in function. The packaging components and packaging component PMD return to station 8, and are correlated with the product packaging PMD in step 146 using the dual read and compare routine.<br />The product is packaged in step 147 and the packaging process parameters are recorded in the product packaging PMD along with the date and packaging person I.D.<br />After the product is finally packaged in step 147, it must be labeled.<br />Labels maintained in stock have a label stock PMD 28 associated therewith which includes label identification including product name, strength, dosage form, content quantity and label lot number, whether the labels have been accepted, the date labels were received, the total quantity received and information relating to reconciliation.<br />The packaging component PMD 27 is used when labels are obtained from the label stock by first doing a dual read and compare with the label stock PMD at station 11 in step 151 to verify the product identification information on both. Upon verification, the label lot number and the fact that the labels were accepted is written into the packaging component PMD 27 in step 152 from the label stock PMD in station 11. Moreover, the quantity of labels dispensed and the I.D. of the person doing the dispensing is written into the packaging material PMD.<br />The information in the packaging component PMD 27 relating to the batch number of the product and the quantity of labels dispensed is read from the packaging component PMD and written into the label stock PMD in step 153.<br />The labels and the packaging component PMD 27 return to station 10 and are correlated with the product packaging PMD 26 using the dual read and compare routine. The labeling is performed in step 155 and the product packaging PMD is updated with the identification of the labeling person and the labeling meet the requirements thereof. The packaging component PMD is annotated with the returned and destroyed labels. The returned labels and the packaging component PMD move back to station 11 to update the label stock PMD with the returned and destroyed label data to provide for positive label stock reconciliation.<br />After the labeling is completed, in step 156 a product sample PMD 29 is formatted by writing the product identification, sample quantity required and the required tests from the product packaging PMD. The product sample PMD travels with the product sample which is thereafter tested at station 12 in step 157 and returned to station 10 where a dual read and compare is performed in step 158 to verify the product identification codes on the product sample PMD and the product packaging PMD. The product inspection data which was written into the product sample PMD during inspection, is then written from the product sample PMD into the product packaging PMD in step 159.<br />For each recording of data into the PMD's described above, there is preferably a later transfer of that data from the PMD into the main processor 15.<br />In accordance with the invention shown in FIG. 6, each receiving station includes a computer terminal 40, a bar code label printer 41 controlled by the terminal and a bar code scanner 42 which inputs data into the terminal.<br />In one embodiment of the present invention, the system includes a receiving station 43A, a quarantine station 43B, a test station 43C, a warehouse storage area 43D, a dispensing station 43E, a manufacturing station 43F, process sampling station 43G, a packaging station 43H, a product quarantine station 43I and a shipping station 43J. All of the stations are connected via a bus to main computer 44 which is connected to a compact disk archiving system 45 and a checkcode circuit 46.<br />Each entry made at each computer terminal 40 is only permitted after an operator enters an electronic signature which includes a name code or bar code identifying the operator and a password. This information, along with a time and date stamp from the computer terminal, is sent over the bus to the main computer 44. All data to be stored in main computer 44 is first applied to the checkcode circuit which generates a word to be stored along with the data which is representative of the data, the time and date that the data was sent to the main computer for storage and the electronic signature of the operator. In one embodiment of the present invention, the check code generator generates a first group of encrypted data bits corresponding to the operator and unique to that operator, a second group of encrypted data bits representative of the time and date and a third group of bits corresponding to a check sum of the digits of the data. This word is stored in memory with the data itself. Any attempt by a person to change the data in the data word would result in an error being detected. Moreover, any change to the check code would enable the system to determine that the change was made by an unauthorized person or at a date inconsistent with the operation performed.<br />In the embodiment of the present invention shown in FIG. 7, lot data is received in step 51 and a bar code label is printed in receiving station 43A in step 52. The lot is then sent to quarantine station 43B in step 54 and a bar code label is printed with the sample requirements in step 55. The labels on the lot are read in step 56 in test station 43C wherein samples are removed and tested in step 57. A bar code label with the location number to release the lot is generated in step 58 and the lot is then stored in warehouse 43D in step 59.<br />When a lot is requested from a location in the warehouse in step 60, the material is received in a dispensing station 43E in step 61. At that time, the labels on the material are read in step 62 and material request bar code labels are printed in step 63. The materials are received in a manufacturing station 43F in step 64 and labels are read in step 65. The manufacturing steps are performed in step 66 and bar code labels corresponding to the results of those steps are printed in step 67 and applied to the materials.<br />The labels are read in test or sampling station 43G in step 68 and the test results are reported in step 69 with a bar code label printed for the test procedure in step 70.<br />The tested material then has packaging requirement bar code labels printed in step 71 and these labels on the materials are read at packaging station 43H in step 72 wherein packaging steps 73 are performed. Product bar code labels are printed in step 74 and the product is received in a quarantine station 43I in step 75. The labels are read in the quarantine station in step 76 and samples are inspected in step 77 and release bar code labels are printed in step 78. The labels are then read at shipping station 43j in step 79 and shipping labels are printed in step 80.<br />Along the way the data for each of the bar code labels is stored in main computer 44 and thereafter archived on a computer disk in the CD archive system 45 after having the checkcode for each data word generated in the checkcode circuit 46.<br />It is understood that the embodiments described hereinabove are merely illustrative and are not intended to limit the scope of the invention. It is realized that various changes, alterations, rearrangements and modifications can be made by those skilled in the art without substantially departing from the spirit and scope of the present invention.shahzadhttp://www.blogger.com/profile/01364507074991292353noreply@blogger.comtag:blogger.com,1999:blog-7305327264533069235.post-10438987183417768722009-06-11T21:32:00.000-07:002009-06-19T23:03:58.411-07:00QUALITY MANAGEMENTThe Management is committed to the development and implementation of the quality management system. The effectiveness and continual improvement of quality management system is being monitored.The employees are trained in respective functional areas depending upon their qualification, experience, area of working and assigned functions of individual. They are trained in relation to their particular function, which complies with cGMP.<br />Self-inspection programmes to ascertain the compliance with the GMP requirements. The standard operating procedures are prepared and followed.Quality Assurance inspector carries out shop floor inspection in order to ensure compliance with the standard operating procedures (S.O.P.) and instruction in batch manufacturing records (B.M.R.). In-process inspection and analysis is carried out to ensure that the product is manufactured as per the S.O.P. and B.M.R. cGMP is being adhered to and product conforms to the specification.<br />A team of Q.A. personnel and production personnel audits vendors of raw and packaging material and their observations are documented as per S.O.P.<br />Raw material and packing material are received as per S.O.P. They are Quarantined and entered in the stock registers and “QUARANTINE” label is affixed. The intimation is given to Quality Control department through GRN. They are sampled as per the Sampling plans as given in the SOP and analyzed as per Pharmacopoeial standards and in - house specification.<br />If the material complies with the specifications then the Q.C. department releases the approval of the materials by affixing a status label “APPROVED” to the raw and packing material containers. These procedures are carried out as per the S.O.P.<br />The testing of the finished products is carried out as per the S.O.P. Each sample is tested as per the finished product specification. Relevant approvals are sent to respective production department to bulk product and to finished product store. If the batch fails, it is kept under “HOLD” and laboratory failure investigation is carried out. Finished pack samples are also tested for batch coding and other details.<br />Product release: After the completion of the batch packing by the packaging department the product is transferred to the “FINISHED PRODUCT QUARANTINE”. Q.A. department checks and verifies all the documents of that batch and gives “RELEASE” to the finished good stores for the distribution and sales.<br />At Sparsh Bio-Tech Pvt. Ltd Quality Assurance & Quality control are individual department with full authority to approve or Reject anything, which they feel is not according to cGMP.shahzadhttp://www.blogger.com/profile/01364507074991292353noreply@blogger.comtag:blogger.com,1999:blog-7305327264533069235.post-65606227524435975752009-05-29T02:55:00.000-07:002009-05-29T03:09:23.099-07:00Vibrating SifterPURPOSE <br /><br /> It is established to provide a proper procedure for sifting of material through vibration.<br /><br /> SCOPE<br /><br /> It is applicable in Granulation Section.<br /><br /> RESPONSIBILITY<br /><br /> Maintenance officer (Mechanical / Electrical)<br /> Maintenance Supervisor (Mechanical / Electrical)<br /> <br /> PROCEDURE<br /><br />The Vibrating Sifter with instrument is handled in the following way.<br /><br /> MAINTENANCE<br /><br /> MONITORING OF MACHINE MAINTENANCE:<br /><br /> Time to time check each and every part of Vibrating Sifter according to the maintenance schedule. Check the following parts carefully.<br />vElectric motor<br />vElectric Contactor<br />vShaft & Bearings<br />vVibrating Rubber<br />vMesh<br /> This activity is then documented in the form Machinery & Equipment Maintenance Log Check the Vibrating Sifter condition time to time to find any kind of problem during EMERGENCY / BREAKDOWN MONITORING:<br /> Maintenance Manager receives Maintenance Work Order duly signed by the section incharge of the concerned machinery or equipment.<br /> Maintenance Work Order is assigned a number according to the receiving in the Maintenance Reference Register .<br /> Maintenance Manager assigns the maintenance work to the concerned personal<br /> After the completion of work the section incharge signs the completion of Work Order.<br /> All the record is filed and kept by the Maintenance Supervisor.<br /><br /><br /> PRECAUTION:<br /><br /> If find any problem in the alignment of the machine stop over the procedure.<br /> If find any kind of abnormal noise, immediately stop the machine and maintain it.<br /> operation. All the monitoring record is filed and kept by the Maintenance Supervisor.shahzadhttp://www.blogger.com/profile/01364507074991292353noreply@blogger.comtag:blogger.com,1999:blog-7305327264533069235.post-4043281453697326662009-05-29T02:43:00.000-07:002009-05-29T02:54:45.888-07:00Nitrogen Delivery ApparatusPURPOSE <br /><br /> It is established to provide a proper procedure of nitrogen delivery procedure in the Ampoule/Vial filling department.<br /><br /> SCOPE<br /><br /> It is applicable in the Ampoule/Vial filling department.<br /><br /> RESPONSIBILITY<br /><br /> Maintenance officer (Mechanical)<br /> Maintenance Supervisor (Mechanical)<br /> <br /> PROCEDURE<br /><br />The Nitrogen Delivery Apparatus with instrument is handled in the following way.<br /><br /> MAINTENANCE<br /><br /> MONITORING OF MACHINE MAINTENANCE:<br /><br /> Time to time check each and every part of Nitrogen Delivery Apparatus to according to the maintenance schedule. Check the following parts carefully.<br />vFilters<br />vS , S Bolts<br />vS , S Legs<br /> This activity is then documented in the form Machinery & Equipment Maintenance Log Check the Nitrogen Delivery Apparatus condition time to time to find any kind of All the monitoring record is filed and kept by the Maintenance Supervisor.<br /> EMERGENCY / BREAKDOWN MONITORING:<br /><br /> Maintenance Manager receives Maintenance Work Order duly signed by the section incharge of the concerned machinery or equipment.<br /> Maintenance Work Order is assigned a number according to the receiving in the Maintenance Reference Register.<br /> Maintenance Manager assigns the maintenance work to the concerned personal<br /> After the completion of work the section incharge signs the completion of Work Order.<br /> All the record is filed and kept by the Maintenance Supervisor.<br /><br /><br /> PRECAUTIONS:<br /><br /> Always handled by trained staff.<br /> problem during operation.shahzadhttp://www.blogger.com/profile/01364507074991292353noreply@blogger.com