A 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.
1. A method for record keeping, comprising the steps of:
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;
reading the first data record holder at a quarantine station;
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
reading the second data record holder at the quarantine station;
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
storing the first, second and third data records in a main data storage device.
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.
BACKGROUND OF THE INVENTION
The present invention relates to a system for assuring compliance with procedures in ongoing production processes and in particular a pharmaceutical recordkeeping system.
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.
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.
SUMMARY OF THE INVENTION
The main object of the present invention is to provide an automated system for assuring compliance and permanent records of ongoing production processes.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
DETAILED DESCRIPTION OF THE INVENTION
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.
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.
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.
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.
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.
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.
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.
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.
The manufacturing process uses components of raw materials which have been accepted and placed in usable stock.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
After the product is finally packaged in step 147, it must be labeled.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Saturday, June 20, 2009
Thursday, June 18, 2009
Complaints handling and product recall
1- Complaints handling:
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.
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.
3- Any received complaint, investigation carried out and their results should be documented.
4- To consider the possibility of recurrence of the same defect at other batches for the same when investigating any quality complaint.
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.
2-Recalled products:
1- Recalled products for quality reasons should be handled according to approved and documented procedures.
2- A qualified person should be appointed to be in charge of recall or pull out procedures.
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.
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.
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.
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.
3- Goods’ Return from distribution points:
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.
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.
3- In case products are returned for pure commercial reason of no relation to the product’s quality the following instructions should be followed:
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.
b- Any reissued stock should be labeled and to add its data within stock records.
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.
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.
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
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.
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.
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.
3- Any received complaint, investigation carried out and their results should be documented.
4- To consider the possibility of recurrence of the same defect at other batches for the same when investigating any quality complaint.
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.
2-Recalled products:
1- Recalled products for quality reasons should be handled according to approved and documented procedures.
2- A qualified person should be appointed to be in charge of recall or pull out procedures.
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.
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.
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.
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.
3- Goods’ Return from distribution points:
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.
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.
3- In case products are returned for pure commercial reason of no relation to the product’s quality the following instructions should be followed:
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.
b- Any reissued stock should be labeled and to add its data within stock records.
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.
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.
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
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.
1- 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.
1- Periodic stock reconciliation should be performed by comparing the actual and recorded stocks.
2- All significant stock discrepancies should be investigated as a check against inadvertent mix-ups and/or incorrect issue.
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.
4- Damaged containers should not be issued unless the quality of the material has been shown to be unaffected.
5- Regular checks should be carried out for all stocks to identify and remove obsolete and outdated materials or products.
3- Stock Dispatch procedures and instructions:
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.
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.
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.
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.
5- The dispatch of pharmaceutical products should be commenced only after the receipt of a valid and documented delivery order.
6- Records for the dispatch of material and products should be prepared and should include at least the following information:
date of dispatch
name, address and status of the intermediate (if applicable) and final receiver (e.g. retail pharmacy, hospital, community clinic)
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.
Quantity of the products, i.e. number of containers and quantity and size per container.
assigned batch number and expiry date or retest date for starting materials
required transport and storage conditions
Unique serial number to allow identification and traceability of the delivery order.
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.
8- Each party involved in the distribution chain has a responsibility to ensure traceability for dispatched materials or products.
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.
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.
4- TRANSPORTATION AND PRODUCTS IN TRANSIT
1. Materials and pharmaceutical products should be transported in such a manner that doesn’t allow:
The loss of their identity.
Its contamination by weather, surrounding environment r by other products.
Its spillage, breakage or spoilage.
Misappropriation and theft.
Exceeding of appropriate temperature and relative humidity conditions in the case of pharmaceutical products, as appropriate which could negatively affect the quality.
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.
3. To ensure communicating all relevant conditions and precautions for storage and transportation to the entity(-ies) responsible for the transportation of pharmaceutical products.
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:
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.
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.
5. transported consignment components should be labeled and documented with their storage requirements to be followed during transportation.
6. Proper and identifying documents should be accompanied during transportation available for review by authorities or similar entities.
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).
8. Storage conditions as temperature degrees should be recorded periodically. Such records should be available for review on request.
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.
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 freezing
1- Periodic stock reconciliation should be performed by comparing the actual and recorded stocks.
2- All significant stock discrepancies should be investigated as a check against inadvertent mix-ups and/or incorrect issue.
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.
4- Damaged containers should not be issued unless the quality of the material has been shown to be unaffected.
5- Regular checks should be carried out for all stocks to identify and remove obsolete and outdated materials or products.
3- Stock Dispatch procedures and instructions:
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.
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.
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.
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.
5- The dispatch of pharmaceutical products should be commenced only after the receipt of a valid and documented delivery order.
6- Records for the dispatch of material and products should be prepared and should include at least the following information:
date of dispatch
name, address and status of the intermediate (if applicable) and final receiver (e.g. retail pharmacy, hospital, community clinic)
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.
Quantity of the products, i.e. number of containers and quantity and size per container.
assigned batch number and expiry date or retest date for starting materials
required transport and storage conditions
Unique serial number to allow identification and traceability of the delivery order.
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.
8- Each party involved in the distribution chain has a responsibility to ensure traceability for dispatched materials or products.
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.
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.
4- TRANSPORTATION AND PRODUCTS IN TRANSIT
1. Materials and pharmaceutical products should be transported in such a manner that doesn’t allow:
The loss of their identity.
Its contamination by weather, surrounding environment r by other products.
Its spillage, breakage or spoilage.
Misappropriation and theft.
Exceeding of appropriate temperature and relative humidity conditions in the case of pharmaceutical products, as appropriate which could negatively affect the quality.
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.
3. To ensure communicating all relevant conditions and precautions for storage and transportation to the entity(-ies) responsible for the transportation of pharmaceutical products.
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:
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.
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.
5. transported consignment components should be labeled and documented with their storage requirements to be followed during transportation.
6. Proper and identifying documents should be accompanied during transportation available for review by authorities or similar entities.
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).
8. Storage conditions as temperature degrees should be recorded periodically. Such records should be available for review on request.
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.
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 freezing
Quality Management and documentation
1- Quality Management:
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.
1-2 Quality management should include:
Appropriate infrastructure or “quality system”, encompassing the organizational structure, procedures, processes and resources; and
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”.
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.
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:
Available for review
To clearly explain work procedures.
To include and document all activities and procedures followed in the storage premises.
To clearly identify the distribution channels for materials and products.
2-3 among others, written standardized operation procedures (SOP) should be in place for the following:
Dealing with expired stock
Procedures to be followed in case of RECALL of any products.
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.
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:
Brand name, International Non-Proprietary Name (INN) name/s
recommended storage conditions,
any precautions to be observed
retest dates
Pharmacopoeial requirements
Art work of labels and containers.
Safety and first aid instructions.
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:
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)
quality
quantity
supplier
supplier’s batch number
the date of receipt
assigned batch number
Expiry date.
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…
3- Labeling
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:
- Material or product name (Brand name if applicable and the INN name in addition to pharmacopeias if applicable)
- Quantity (weight, size, unit number)
- Batch number
- Expiry date or retest date for active ingredients.
- Receiving date
- Production date
- Quality Control section approval and release date with signature of person in charge.
- Storage conditions (clear and specific)
- Transportation conditions and precautions.
- Handling precautions
- Manufacturer name with its trade mark.
- Supplier’s name (in case it is a wholesaler or so) with contact details.
- 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.
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 rec
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.
1-2 Quality management should include:
Appropriate infrastructure or “quality system”, encompassing the organizational structure, procedures, processes and resources; and
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”.
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.
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:
Available for review
To clearly explain work procedures.
To include and document all activities and procedures followed in the storage premises.
To clearly identify the distribution channels for materials and products.
2-3 among others, written standardized operation procedures (SOP) should be in place for the following:
Dealing with expired stock
Procedures to be followed in case of RECALL of any products.
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.
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:
Brand name, International Non-Proprietary Name (INN) name/s
recommended storage conditions,
any precautions to be observed
retest dates
Pharmacopoeial requirements
Art work of labels and containers.
Safety and first aid instructions.
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:
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)
quality
quantity
supplier
supplier’s batch number
the date of receipt
assigned batch number
Expiry date.
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…
3- Labeling
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:
- Material or product name (Brand name if applicable and the INN name in addition to pharmacopeias if applicable)
- Quantity (weight, size, unit number)
- Batch number
- Expiry date or retest date for active ingredients.
- Receiving date
- Production date
- Quality Control section approval and release date with signature of person in charge.
- Storage conditions (clear and specific)
- Transportation conditions and precautions.
- Handling precautions
- Manufacturer name with its trade mark.
- Supplier’s name (in case it is a wholesaler or so) with contact details.
- 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.
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 rec
Storage area Organizing and handling of stored items
A- Handling of material at storage area
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.
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.
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.
4- Starting material and products should be isolated and be properly labeled in a way which prevents mix-up and cross contamination.
5- Stored materials and products should be stored ( kept within containers) that:
Don’t affect the quality of products negatively.
Provide the proper protection from the surrounding environmental factors as well microbial contamination.
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.
7- Broken or damaged items should be withdrawn from usable stock, separated and labeled clearly.
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.
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.
B- Monitoring and control of storage conditions during storing and transportation
1- It is recommended that temperature monitors be located in areas that are most likely to show fluctuations according to a validated plan.
2- All recorded temperature and humidity monitoring data recorded out of continuous monitoring should be:
Available for review.
Comprise all the results of the regular checks made at suitable predetermined intervals recorded and retained from equipment designated for monitoring temperature degrees.
Kept for at least the shelf-life of the stored material or product plus one year.
Temperature mapping should show uniformity of the temperature across the storage facility or transporting vehicle.
C- Hygiene 1- Storage areas should be clean, and free from accumulated waste and vermin. A written validated sanitation program should be available indicating:
Frequency of cleaning
Methods to be used to clean the premises and storage areas.
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.
Written program for disinfection methods mentioning the periodic exchange of used disinfectants in a way prevents microbial resistance.
Written program for maintaining used cleaning tools (utensils) clean.
Procedures for the clean up of any spillage to ensure complete removal of any risk of contamination.
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.
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.
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.
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.
4- Starting material and products should be isolated and be properly labeled in a way which prevents mix-up and cross contamination.
5- Stored materials and products should be stored ( kept within containers) that:
Don’t affect the quality of products negatively.
Provide the proper protection from the surrounding environmental factors as well microbial contamination.
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.
7- Broken or damaged items should be withdrawn from usable stock, separated and labeled clearly.
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.
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.
B- Monitoring and control of storage conditions during storing and transportation
1- It is recommended that temperature monitors be located in areas that are most likely to show fluctuations according to a validated plan.
2- All recorded temperature and humidity monitoring data recorded out of continuous monitoring should be:
Available for review.
Comprise all the results of the regular checks made at suitable predetermined intervals recorded and retained from equipment designated for monitoring temperature degrees.
Kept for at least the shelf-life of the stored material or product plus one year.
Temperature mapping should show uniformity of the temperature across the storage facility or transporting vehicle.
C- Hygiene 1- Storage areas should be clean, and free from accumulated waste and vermin. A written validated sanitation program should be available indicating:
Frequency of cleaning
Methods to be used to clean the premises and storage areas.
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.
Written program for disinfection methods mentioning the periodic exchange of used disinfectants in a way prevents microbial resistance.
Written program for maintaining used cleaning tools (utensils) clean.
Procedures for the clean up of any spillage to ensure complete removal of any risk of contamination.
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.
Premises, Instruments and vehicles
A- Premises:
1- Design and Layout of the storage site:
1-1 Storage areas should be designed or adapted to ensure the following good storage conditions:
Proper cleanliness & Hygiene.
Dry (relative humidity not more than 60%)
Temperature should be within acceptable limits (8-25 degrees Celsius).
Stored Goods and Materials should be stored off the floor
Suitably spaced to permit cleaning and inspection.
Pallets should be kept in a good state of cleanliness and repair.
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:
Raw materials.
Packaging material.
Intermediate material.
Finished product.
Quarantined substances.
Approved products.
Rejected products.
Recalled products.
Returned products.
Dangerous material.
Inflammable substances.
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.
2- Specifications of the storage area
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.
2-2 Storing area should have sufficient light to perform tasks in a correct, safe and accurate manner.
2-3 In case of windows presence in the storage area, arrangements should be made to block Sunlight away from the stored items.
2-4 All surfaces, shelves, cupboards used should be covered with an impermeable and easy to clean smooth layer.
3- Receiving and dispatching area:
Receiving and dispatch bays should protect products from the weather.
Reception areas should be designed and equipped to allow containers of incoming pharmaceutical products to be cleaned, if necessary, before storage.
4- Quarantine area:
Quarantined material and Pharmaceutical products should be kept in specified quarantine areas until approved. This area should be:
Well isolated, separated and clearly labeled.
Restricted only for authorized personnel.
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.
5- Sampling area:
There should be a designated area for sampling of primary material provided that it is:
Isolated and of controlled and monitored environment.
Sampling should be done in a certain manner to avoid contamination and cross contamination and according to a documented procedure.
There should be a written cleaning procedure for cleaning of the sampling area effectively.
6- Rejected product area:
There should be a physical separation for defected products, rejected products, expired or recalled products so that it should be:
Well controlled and prevent their use until a final decision is taken on their fate.
It should be clearly labeled.
Locked and restricted only to authorized personnel.
B- Instruments:
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.
All equipment should be calibrated and validated periodically including temperature monitoring devices, humidity monitoring devices and scales.
C-Vehicles:
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.
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.
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.
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.
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.
Special protective precautions should be followed for transporting products or materials which not provided with any protective packaging.
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
monitoring data should be reviewed on receipt of pharmaceutical products to assess whether required storage conditions have been met.
Vehicles and containers should be of sufficient capacity to allow orderly storage of the various categories of pharmaceutical products during transportation.
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.
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.
1- Design and Layout of the storage site:
1-1 Storage areas should be designed or adapted to ensure the following good storage conditions:
Proper cleanliness & Hygiene.
Dry (relative humidity not more than 60%)
Temperature should be within acceptable limits (8-25 degrees Celsius).
Stored Goods and Materials should be stored off the floor
Suitably spaced to permit cleaning and inspection.
Pallets should be kept in a good state of cleanliness and repair.
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:
Raw materials.
Packaging material.
Intermediate material.
Finished product.
Quarantined substances.
Approved products.
Rejected products.
Recalled products.
Returned products.
Dangerous material.
Inflammable substances.
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.
2- Specifications of the storage area
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.
2-2 Storing area should have sufficient light to perform tasks in a correct, safe and accurate manner.
2-3 In case of windows presence in the storage area, arrangements should be made to block Sunlight away from the stored items.
2-4 All surfaces, shelves, cupboards used should be covered with an impermeable and easy to clean smooth layer.
3- Receiving and dispatching area:
Receiving and dispatch bays should protect products from the weather.
Reception areas should be designed and equipped to allow containers of incoming pharmaceutical products to be cleaned, if necessary, before storage.
4- Quarantine area:
Quarantined material and Pharmaceutical products should be kept in specified quarantine areas until approved. This area should be:
Well isolated, separated and clearly labeled.
Restricted only for authorized personnel.
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.
5- Sampling area:
There should be a designated area for sampling of primary material provided that it is:
Isolated and of controlled and monitored environment.
Sampling should be done in a certain manner to avoid contamination and cross contamination and according to a documented procedure.
There should be a written cleaning procedure for cleaning of the sampling area effectively.
6- Rejected product area:
There should be a physical separation for defected products, rejected products, expired or recalled products so that it should be:
Well controlled and prevent their use until a final decision is taken on their fate.
It should be clearly labeled.
Locked and restricted only to authorized personnel.
B- Instruments:
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.
All equipment should be calibrated and validated periodically including temperature monitoring devices, humidity monitoring devices and scales.
C-Vehicles:
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.
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.
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.
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.
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.
Special protective precautions should be followed for transporting products or materials which not provided with any protective packaging.
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
monitoring data should be reviewed on receipt of pharmaceutical products to assess whether required storage conditions have been met.
Vehicles and containers should be of sufficient capacity to allow orderly storage of the various categories of pharmaceutical products during transportation.
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.
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.
Concerned establishments and Scope
A) Establishments concerned
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:
Medical stores.
Stores as part of pharmaceutical and medical devices manufacturing establishments.
Nutrition & Health Dietary Supplements food stores.
Herbal pharmaceutical stores.
Private pharmacies and hospital pharmacies.
Stores designated for storing pharmaceuticals and medical products at health establishments like hospitals and Public Healthcare institutions.
B) Management and Personnel:
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.
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.
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).
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.
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.
6- Personnel employed in storage areas should wear suitable protective or working garments appropriate for the activities they perform.
7- First-aid procedures and equipment for dealing with emergencies involving personnel should be available.
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.
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.
B- Contracting with third party:
1- Contracting (outsourcing) of certain storing or distribution services or activities is acceptable, given that these are outsourced from qualified and legitimate parties.
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.
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:
Medical stores.
Stores as part of pharmaceutical and medical devices manufacturing establishments.
Nutrition & Health Dietary Supplements food stores.
Herbal pharmaceutical stores.
Private pharmacies and hospital pharmacies.
Stores designated for storing pharmaceuticals and medical products at health establishments like hospitals and Public Healthcare institutions.
B) Management and Personnel:
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.
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.
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).
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.
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.
6- Personnel employed in storage areas should wear suitable protective or working garments appropriate for the activities they perform.
7- First-aid procedures and equipment for dealing with emergencies involving personnel should be available.
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.
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.
B- Contracting with third party:
1- Contracting (outsourcing) of certain storing or distribution services or activities is acceptable, given that these are outsourced from qualified and legitimate parties.
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.
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