Thursday, June 18, 2009
Definitions and technical terms
Batch
A defined quantity of starting material, packaging material or product processed in a single process or series of processes so that it is expected to be homogeneous.
Batch number
A distinctive combination of numbers and/or letters which uniquely identifies a batch on the labels, its batch records and corresponding certificates of analysis, etc.
Consignment (or delivery)
The quantity of a pharmaceutical(s), made by one manufacturer and supplied at one time in response to a particular request or order. A consignment may comprise one or more packages or containers and may include material belonging to more than one batch.
Container
The material employed in the packaging of a pharmaceutical product. Containers include primary, secondary and transportation containers. Containers are referred to as primary if they are intended to be in direct contact with the product. Secondary containers are not intended to be in direct contact with the product.
Contamination
The undesired introduction of impurities of a chemical or microbiological nature, or of foreign matter, into or on to a starting material, intermediate or pharmaceutical product during handling, production, sampling, packaging or repackaging, storage or transport.
Counterfeit
À counterfeit medicine is one which is deliberately and fraudulently mislabelled with respect to identity and/or source. Counterfeiting can apply to both branded and generic products and counterfeit products and may include products with the correct ingredients or with the wrong ingredients, without active ingredients, with insufficient active ingredients or with fake packaging.
Cross-contamination
Contamination of a starting material, intermediate product or finished product, with another starting material or product during production.
Distribution
The division and movement of pharmaceutical products from the premises of the manufacturer of such products, or another central point, to the end user thereof, or to an intermediate point by means of various transport methods, via various storage and/or health establishments.
Expiry date
The date given on the individual container (usually on the label) of a product up to and including which the product is expected to remain within specifications, if stored correctly. It is established for each batch by adding the shelf-life to the date of manufacture.
Labeling
Process of identifying a product, by choosing and attaching the primary and secondary packaging (container) with the right label which includes all needed information regarding the product or material.
Manufacture
All operations of purchase of materials and products, production, quality control, release, storage and distribution of pharmaceutical products, and the related controls.
Material
A general term used to denote starting materials (active pharmaceutical ingredients and excipients), reagents, solvents, process aids, intermediates, packaging materials and labeling materials.
Active pharmaceutical ingredient (API)
Any substance or mixture of substances intended to be used in the manufacture of a pharmaceutical dosage form and that, when used in the production of a drug, becomes an active ingredient of that drug. Such substances are intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment or prevention of disease, or to affect the structure and function of the body.
Pharmaceutical product
Any medicine intended for human use or veterinary product administered to food producing animals, presented in its finished dosage form or as a starting material for use in such a dosage form, that is subject to control by pharmaceutical legislation in both the exporting state and the importing state.
Product recall
Product recall is a process for withdrawing or removing a pharmaceutical product from the pharmaceutical distribution chain because of defects in the product or complaints of serious adverse reactions to the product. The recall might be initiated by the manufacturer/importer/ distributor or a responsible agency.
Quality assurance
Quality assurance is a wide-ranging concept covering all matters that individually or collectively influence the quality of a product. It is the totality of the arrangements made
with the object of ensuring that pharmaceutical products are of the quality required for their intended use.
Quality control
Quality control covers all measures taken, including the setting of specifications, sampling, testing and analytical clearance, to ensure that starting materials, intermediates, packaging materials and finished pharmaceutical products conform with established specifications for identity, strength, purity and other characteristics.
Quality system
An appropriate infrastructure, encompassing the organizational structure, procedures, processes and resources, and systematic actions necessary to ensure adequate confidence that a product (or services) will satisfy given requirements for quality.
Quarantine
The status of starting or packaging materials, intermediates, or bulk or finished products isolated physically or by other effective means while a decision is awaited on their release, rejection or reprocessing.
Shelf-life
The period of time during which a finished pharmaceutical product, if stored correctly, is expected to comply with the specification as determined by stability studies on a number of batches of the product. The shelf-life is used to establish the expiry date of each batch.
Standard operating procedure (SOP)
An authorized, written procedure giving instructions for performing operations not necessarily specific to a given product but of a more general nature (e.g. equipment operation, maintenance and cleaning, validation, cleaning of premises and environmental control, sampling and inspection).
Storage
The storing of pharmaceutical products up to the point of use.
Validation
A documented program that provides a high degree of assurance that a specific process, method or system will consistently produce a result meeting pre-determined acceptance criteria.
Vehicle
Vehicle refers to trucks, vans, buses, minibuses, cars, trailers, aircraft, railway carriages, boats and other means which are used to convey pharmaceutical products.
Supplier:
A person or party which provide the concerned establishment, pharmaceutical products and materials on request. Suppliers may be agents, brokers, distributors, manufacturers or traders. Suppliers should be authorized by a competent authority.
Retest date:
The date when a material should be re-examined to ensure that it is still suitable for use.
Normal Storage Conditions
Means to practice storage under environmental conditions described as dry with a good ventilation within temperature degrees range between 15 to 25 degrees Celsius that could extend to 30 degrees Celsius as marginal limit. The storage environment should be protected from any external vapors or smells, contamination factors and extensive direct light.
Packaging material
Any material, including printed material, employed in the packaging of a pharmaceutical product, but excluding any outer packaging used for transportation or shipment. Packaging materials are referred to as primary or secondary according to whether or not they are intended to be in direct contact with the product.
Specific Storage conditions:
Some pharmaceutical products require specific conditions to be stored within, and needs special instructions for storage handling and methods.
Interpretation of instructions included on the product label:
Not to exceed 30 Degree Celsius: means to store within the range from +2 to +30 Degrees Celsius.
Not to exceed 25 Degree Celsius: means to store within the range from +2 to +25 Degrees Celsius
Not to exceed 15 Degree Celsius: means to store within the range from +2 to +15 Degrees Celsius.
Not to exceed 8 Degree Celsius: means to store within the range from +2 to +8 Degrees Celsius.
Do not store below 8 Degree Celsius: means to store within the range from +8 to +25 Degrees Celsius.
The product should be protected from humidity: means to protect it from conditions where humidity exceeds 60%, and should be kept in a humidity resistant container.
Keep away from light: means that should be stored in places not exposed to light. It should be kept in light proof containers.
Good Storage Practices"
On the WHO homepage you can now find a topical document titled Guide to Good Storage Practices for Pharmaceuticals, which has been elaborated in close co-operation with the International Pharmaceutical Federation (FIP) and which will thus probably replace the quite old FIP Guideline on Good Storage Practices of 1980.
The new WHO document on GMP-compliant storage represents a complement to existing GMP regulations issued by WHO. These new Good Storage Practices are valid not only for manufacturers of medicinal products, but also for pharmaceutical importers, contractors and wholesalers.
The focus topics are:
- Personnel
- Premises and facilities
- Storage requirements
- Returned goods
- Dispatch and transport
- Product recall
Compared to the former FIP Guideline, several new requirements have been added, some old ones, specified. Here some examples:
- Precautions must be taken to prevent unauthorised persons from entering storage areas.
- Materials and pharmaceutical products must not be stored directly on the floor.
- There should be written programmes for many work routines (sanitation, pest control, measures in case of spillage, cleaning procedures for the sampling area, handling of returned goods, etc.).
- Computerised systems used for storage administration (incl. quarantine and storage of rejected materials) have to be validated.
- The traditional term "First in – First out" (FIFO) is now replaced correctly by the more specific "first expired/first out" (FEFO) principle.
- In addition to the usual GMP requirements on the monitoring of storage conditions (temperature recording with calibrated equipment), temperature mapping should prove the uniformity of the temperature.
- Returned goods may only be returned to saleable stock after the quality has been re-evaluated.
In case patients have returned pharmaceuticals, these must not under any circumstances be returned to the saleable stock. - As for transport, especially the use of dry ice in cold chains is discussed (danger of damaging materials by freezing them accidentally) and the monitoring of transport conditions with the help of appropriate recording devices is recommended.
An appendix to the new WHO Guideline lists standardised storage and labelling conditions for drug products, which had already been fixed by WHO in this form in 1996.
Unfortunately, this list does not contain any reference to the Controlled Room Temperature mentioned in the USP under "Stability" in the General Chapter <1151>. The controlled room temperature takes the mean kinetic temperature into account and allows thus for a certain flexibility regarding deviations from the prescribed storage temperature.
By the way, this concept of mean kinetic temperature has also been mentioned in the European CPMP Note for Guidance on Declaration of Storage Conditions for Medicinal Products in the Product Particulars and Active Substances (CPMP/QWP/609/96/Rev.1).
Therefore, it would also have been desirable to read this term in WHO's new Good Storage Practices. But the new Guide just says that temperature deviations may be tolerated only during short-term interruptions, e.g. during local transportation.
Author:
Dr Günter Brendelberger
CONCEPT HEIDELBERG
GOOD WAREHOUSING and DISTRIBUTION PRACTICES
Good Warehouse Practices
1. Premises
2. Security
3. Temperature and humidity control
4. Equipment
5. Personnel
6. Sanitation
7. Receipt of incoming goods
8. Assembling orders and issuing goods
9. Packing for transportation
10. Transport
Premises
Premises should be of suitable size and construction to facilitate cleaning, maintenance and orderly, segregated storage
Storage areas must be designed to provide adequate:
- lightening,
- ventilation,
- temperature,
- sanitation,
- humidity,
- space,
- equipment,
- security conditions
Medicinal products should be stored separate from other goods to avoid the risk of cross contamination
Incoming goods should be physically or electronically separated from goods awaiting distribution until approved by the responsible person
A segregated area must be provided for the holding and storage of returned and rejected goods prior to a decision on further action
A secure, segregated area must be provided for the storage of controlled drugs
A separate, designed area should be provided for the assembly of customer orders
Security
Storage areas should be provided with security to prevent theft or unauthorised entry
Maintain a control of who may enter the facilities
u Establish system for controlling access to the facility (including all entrances and exits)
Temperature and Humidity Control
u All drug products must be stored at appropriate conditions as stated on the label of the product
u The temperature of all storage areas should be regularly monitored.
u Controlled temperature storage areas should be equipped with recorders and devices which indicate when the specific temperature range has not been maintained.
u A written procedure must specify the action to be taken when this occurs Control should be adequate to ensure that all parts of the storage area are kept within the specified temperature range
u Should always be a back up system in case main system fails
u The humidity of all storage areas should be regularly monitored using recorders and devices which document the humidity measures
u If the product spec require a specific humidity, a written procedure must specify the action to be taken when the specified humidity range has not been maintained.
u Establish a normal operating baseline of humidity if no specific value is required
Records of temperature and humidity in all storage areas should be reviewed and retained by a designated responsible person
Equipments
There should be a planned preventative maintenance programme in place
, recording and control equipment should be calibrated and checked at defined intervals by appropriate methods
Alarm set-points should be checked on periodic intervals
A computerised system used for stock control/distribution should be validated
Person
The organisation chart should be in place
There should be a sufficient number of staff
There should be clearly defined job description
Personnel should be trained in relation to good storage and distribution practice and to
the duties assigned to them
The current records of training should be in place
The trainers should have established and approved qualification
Sanitation
A written sanitation program should be in place indicating the frequency and method of cleaning the facility
Storage areas should be cleaned and accumulated waste removed at regular intervals
A pest control program should be in place
Smoking, eating and drinking should be permitted only in segregated areas, and not in those areas used for the storage and handling of final drug product
Spills involving drug products must be promptly cleaned-up and rendered safe in accordance with the relevant health and safety requirements for the product
Adequate toilet and changing facilities should be provided, and they should be segregated from the main storage and order assembly areas
Receipt of incoming goods
It should be carried out according to approved adequate SOP:
visually examine for identity against the relevant supplier’s documentation
visually examine for damage
sub-divide according to batch numbers if more than one batch
reject product if damage or otherwise unfit for use
handle high security materials (control drug, high value items, products requiring a specific storage temperature)
confirm with signature that receiving goods are as specified by supplier or if not provide adequate comments
Assembling orders and issuing goods
It should be carried out according to approved adequate SOP:
Pick up goods according to formal despatch documents
Assemble complete order
>Visually examine for identity and completeness
Visually examine for damage
Confirm with signature properly assembled order
Prepare adequate shipping package to protect any damage of goods, seal pack and provide relevant identification
The heat sensitive drugs if not transported by appropriate specialised means should be provided isolated packing
Packing for transportation
Products should be packed in such a way that:
the identification of the product is not lost,
the product does not contaminate and is not contaminated by other products or materials
adequate precautions are taken against spillage and breakage
products requiring controlled temperature storage should be provided with insulated packs
there should be in place documented evidence that the insulated packs ensured adequate transport conditions with regards to:
- product quantity
- ambient temperature
- maximum delivery time.
Transport
Products should be transported in such a way that:
The safety, identity, strength, quality and purity of the product is not lost
The product is not contaminated by other products or materials
Adequate precautions are taken against spillage or breakage
The product and its package are not subjected to unacceptable degrees of heat, cold, light, moisture or other adverse influences nor to attack by micro-organisms or pests
Drug products requiring controlled temperature storage by appropriate specialised means or should be packed with adequate insulation
Transport
Documents should be provided to cover all shipments. These document should include as minimum:
name of the product
quantity of the product
special storage and handling instructions
Records
Following records should be in place:
receiving goods
issuing goods
training
monitoring temperature and humidity
cleaning operation
pest control
calibration
preventative maintenance
recall
complaints
inventory
log of signature
Good Distribution Practices
1. Personnel
2. Documentation and Records
3. Procedures
4. Computerized system
Documentation and Records
A written or electronic data sheet should exist for each stored product indicating recommended storage conditions, any safety precautions to be observed and the shelf life.
Written procedures should describe the different operations which may affect the quality of the products or of the distribution activity.
Records should be made at the time each operation is taken and in such a way that all significant activities or events are traceable. Records should be clear and readily available. Records should be retained for a period of five years at least.
Procedures
Each procedure should be approved, signed, and dated by the person responsible for the quality system. The following procedure should be developed.
1. Receipt of incoming product
2. Processing orders
3. Stock movement and control
4. Thefts, losses and discrepancies in inventory
5. Returned goods
6. Recall
7. Complaints
8. Disposal of unsaleable goods
9. Repacking and labelling
10.Deviation
11.Change control
Visually examine for identity against the relevant supplier’s documentation
Visually examine for damage
Sub-divide according to batch numbers if more than one batch
Reject product if damage or otherwise unfit for receipt/ distribution
Define the record-keeping process identifying
- source of drug,
- name and address of seller and transferor
- identity of drug
- quantity
- date of receipt and disposition
Handle high security materials (control drug, high value items, products requiring a specific storage temperature)
Processing orders
Formal sales order or formal records of customer’s order requirements
Despatch documents should contained as a minimum:
- date of despatch,
- customer’s name and address,
- product name/ form/ lot number/ expiry date/ quantity sent,
- any special handling or storage instruction,
- additional information according to local or international
regulation,
Visually examine for identity
Visually examine for damage
Not shipped if these requirements are not met
Stock rotation and control
Define process by which product stock should be issued (first in -first out) and any exceptions to process (specific demands from a specific batch)
Define when periodic stock reconciliation should be performed
Define process to be used to investigate any significant stock discrepancies
Define a process of identifying outdated stock and moving it to a quarantine area
Conduct a thorough investigation and document all action
Record losses, thefts or diversions and notify appropriate corporate personnel
Take measures to address the cause of theft, loss or diversion
Returned goods
Products which have left the control of the wholesaler, should only be returned to saleable stock if:
- the goods are in their original unopened containers and in good condition,
- it is known that the goods have been stored and handled under proper conditions,
- the remaining shelf life period is acceptable,
- they have been examined and assessed by a person authorised to do so,
- special attention should be given to products requiring special storage conditions.
All returned goods should be kept apart from saleable stock until approved by a nominated responsible person
Records of returns should be kept, the responsible person should formally release goods to be returned to stock
Recall
Products can only be recalled by decision of the Head of Quality Assurance
Define who contacts regulatory authorities concerning any recall
Define the means whereby recalled products can be traced and obtained from the market
Establish records of any recalled products
Establish segregated storage area for any recalled products
Remove recalled product from saleable stock and store in a segregated area
Only relevant QA Manager or responsible person could make decision on recalled product fate
The effectiveness of the arrangements for recalls should be evaluated from time to time
Complaints
Any complaint concerning a product defect must be immediately reported to supplier and processed according to local regulations
Complaints relating to customer service or shipping errors should be processed according to established procedure
Each received complaint should be recorded
Disposal of unsaleable goods
Stock which is no longer fit for sale must be segregated from other stock before ultimate disposal or destruction
Destruction of unsaleable goods must be carried out in accordance with local legislation or guidelines issued by each manufacturer
There must be a written record kept of all goods destroyed showing product name, batch number, pack size, quantity and methods of destruction
Repacking and labelling
Wherever possible, repacking and labelling process should be carried out at the Principal’s own licensed premises.
In any necessary case of carrying out repacking or labelling process at wholesaler site following factors must be applied:
dedicated area for this operation,
adequate procedure described operation,
each step of the operation should be recorded, records should
also contain identification and quantity of product and packaging materials
all work should be supervised by Principal’s QC or QA
representative
Deviation
Deviation is defined as an accidental departure from established process described in procedures.
Each site should develop a written procedure for processing deviation. Deviation Procedure should include:
- identification of deviation,
- impact of deviation for safety, identity, strength, purity or quality,
- investigation of root cause if rationale,
- corrective action,
- preventative action,
- records of deviation
Change control
Change is defined as a planned alteration or replacement of items such as, but not limited to, the following:
- buildings and facilities,
- equipment,
- storage and distribution procedure.
There should be Change Control SOP in place.
The change must be described and justified.
Determine the impact of the change for various areas.
The proposed change must be reviewed by affected areas.
The change is executed in co-operation with affected areas.
Prior to filing the documentation , an appropriate person must review and approve the completed change to ensure the documentation is complete and accurate.
Records of change must be retained.
The distributor should inform supplier in advance of any significant change he is going to implement.
Computerized system
Computer hardware
- detailed specification (model, version of all hardware, drawings of circuits, networks, routes),
- maintenance (planned and breakdown),
- location and environment,
- change control
Computer Software
Specification should include :
- the version number of all the programmes eg operating systems, source
codes, application languages etc.
- schematics /diagrams illustrating the main architecture of the programme and/or security detections, eg against unauthorised changes
- a programme listing, eg source codes and necessary back-up media, to enable re-installation of the same programme to occur in the event of breakdown etc.
All aspects of computer system should be described in adequate procedures
Every significant modification should be validated
Data should be protected by backing-up at regular intervals
Back-up data should be stored as long as necessary at a separate and secure location
Establish and validate procedure to be followed if system fails or breaks down
Any failures and remedial action taken should be recorded
Establish procedure to record and analyse errors and to enable corrective action to be taken
Implement adequate training program for operators
GOOD WAREHOUSING
Definitions
Warehouse - A facility where company stocks are stored. In Pharma business, typically store raw material, packaging material, semi finished and finished goods.
Distribution - The process in which the finished drug product is moved from the initial warehouse to the final consumer. This process may involve several steps from beginning to end depending on the complexity of any manufacturing /marketing agreements.
Licences
u A potential warehousing and distribution organization must hold all
necessary local government licences covering the storage and/or distribution
of the relevant drug products.
u Deliveries should be made only to other authorized wholesalers or the person
authorised to supply medicinal products to the public in the country.
Personnel
u Key personnel who carry out supervisory and/or controlling functions relating to
warehousing or distribution should possess the necessary integrity, knowledge,
experience, and professional or technical qualifications appropriate to the task
assigned to them.
u The concept of the Responsible Person (RP) was introduced by the Directive
2/25/EEC. The RP should ensure that the conditions of the Wholesale Dealer’s
Licence are met and that the guidelines on Good Distribution Practice are
complied with.
u Personnel should be trained in relation to good storage and distribution practice and to the duties assigned to them. All training should be documented.
u The following aspects should be included in any formal training programme:
- Regulatory Requirements
- Standard Operating Procedures
- Record-keeping
- Security
- Storage Requirements
Tuesday, June 16, 2009
Safe Chemical Storage Practices
Acetaldehyde, acetic acid, cadmium chlorate, copper(II) sulfide, hydrogen peroxide, iron(II) sulfide, sodium cyanide, sulfuric acid...
Alphabetizing is a skill most of us have used since childhood, yet it can be deadly if applied to the storage of laboratory chemicals. Polymerization, explosion, and the generation of highly toxic material could result if neighboring compounds reacted on the "alphabetical" shelf above.
Properly storing chemicals such as acids, bases, and flammable or combustible liquids is essential for maintaining a safe laboratory environment. It is important to grasp the guiding principles of chemical storage, and to explore the options available from manufacturers before you buy safety cabinets for the storage of laboratory chemicals.
Chemical storage guidelines
Information on storage requirements for a given chemical can be found in the MSDS, the manufacturer's label, and chemical reference materials. Together they can provide answers to questions such as: Is the chemical flammable or combustible? Is the chemical corrosive? And Is the chemical light-sensitive? Once such information has been obtained, the appropriate place and method of storage can be determined.
Perhaps the single most important rule in chemical storage is to segregate incompatible chemicals, which could cause fire, explosion, or the generation of toxic gases. For example, acids must not be stored with bases, and oxidizers must not be stored with reducing agents or flammable materials. Chemicals that pose more than one type of hazard may require special storage arrangements.
Storing the least amount of each chemical as possible is also very important. Most chemical suppliers now offer "just-in-time" delivery, so that users can order only the amount of chemical needed for a current task and receive the order at the time it is needed. A good inventory control system also helps minimize the amounts of chemicals being stored by preventing unnecessary purchases.
Flammable and combustible liquids
At UST, CLS maintains a stock of commonly used chemicals and makes prompt deliveries to users, thus eliminating the need for PIs to over stock chemicals in their labs. Acids and corrosives Acids and corrosives While there are no specific regulatory requirements for the storage of nonflammable acids and alkaline corrosives, good storage practices dictate that these chemicals be stored in dedicated, corrosion-resistant cabinets. Acids must be stored separately from bases, and chemical compatibility must be maintained within each dedicated cabinet. For example, acetic acid and nitric acid can react explosively and must be isolated from one another if stored within the same safety cabinet. (Note: Organic acids, such as acetic acid, should be stored with organic solvents instead of inorganic acids.)
Cabinets for acids and corrosives are generally constructed of laminated or epoxy-painted plywood, high density polyethylene, or polypropylene. Epoxy-coated steel cabinets are also available; however, their use is not recommended with nitric or sulfuric acids. With these chemicals, the vapors that emanate from the stored containers contribute strongly to the degradation of metal cabinets. In the case of these two common materials, the former plywood or polymer cabinets should be utilized. It should also be noted that many cabinets also feature metal-free hinge assemblies.
Users should conduct periodic inspection and cleaning (with a neutralizing compound plus soap and water) of all safety cabinets. Look for signs of corrosion within the cabinet and carefully check trays, hinges, locks and metal shelf clips. It is important to remember that the performance of a cabinet will be compromised by corroded or improperly functioning parts.
Flammable and combustible liquids
Flammable liquids have flash points below 37.8¢XC (100¢XF). Those with flash points above 37.8¢XC are "combustibles". Flash point is the minimum temperature at which a liquid gives off vapor within a test vessel in sufficient concentration to form an ignitable mixture with air near the surface of the liquid. According to the HK Fire Services Department regulations, each user must not have more than 120 liters (aggregate) of flammable materials stored outside of licensed Dangerous Goods Stores (for diethyl ether or diisopropyl ether, the aggregate value drops to 2.5 liters). In the case of temporary storage in the laboratory, the quantity must be minimized to meet only daily requirements and shall not at any time exceed the above stated limit. Furthermore, flammable materials are to be stored in appropriate flammable storage cabinets in the laboratory.
(Some of the information in this article was excerpted from Chemical Health and Safety, Vol. 4, No. 4, Jul/Aug 1997, p.33-36.)
MINOR STORAGES OF DANGEROUS GOODS
37. What are minor storages?
Minor storages are dangerous goods storages in quantities below the “Placarding Quantity” in
Schedule 2 of the Regulations. A premises could have a number of such storages and this Part
would be applicable to each storage
38. Relationship with other Parts of this Code
This Part of the Code only applies to minor storages of dangerous goods (other than
dangerous goods on display for retail sale for which part 4 applies).
If this Part of the Code applies to your premises, you will be in compliance with the
Regulations if you follow the guidance in this Part. You do not need to refer to Part 3 of the
Code (except where noted).
39. Risk management for minor storages
39.1 Hazard identification
It is sufficient compliance with Regulation 404 in relation to each minor storage if you
prepare a list of all the dangerous goods in each minor storage that includes:
· the name of each of the dangerous goods;
· the Class, Subsidiary Risk and Packing Group of each of the dangerous goods, and
· a summary of the hazards identified in the MSDS for each of the dangerous goods
The MSDS must be obtained for each of the dangerous goods at the premises. The MSDS
provides the hazard information on the dangerous goods.
39.2 Risk assessment
It is sufficient compliance with Regulation 405 in relation to each minor storage for youto:
· review the MSDS for each of the dangerous goods kept in each minor storage; and
· document the following broad types of risk associated with the dangerous goods in the
minor storage:
– fire and explosion risks associated with the storage and handling of flammable gases
(Class 2.1 or Subsidiary Risk 2.1), flammable liquids (Class 3 or Subsidiary Risk 3),
dangerous goods of Class 4.1, 4.2 and 4.3 or Subsidiary Risk 4.1, 4.2 and 4.3, and
combustible liquids;
– fire risks that may result from the storage and handling of oxidising agents of Class 5.1
or Subsidiary Risk 5.1 or organic peroxides of Class 5.2;
– the toxic risks associated with dangerous goods of Class 6.1 or Subsidiary Risk 6.1; and
– the corrosive risks associated with dangerous goods of Class 8 or Subsidiary Risk 8.
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39.3 Risk control
To control risk associated with minor storage of dangerous goods, implement the following
measures:
Minimise quantities kept
· Consider substituting the dangerous goods with other goods that have a lower risk
associated with their storage and handling. Examples of substitution are the use of:
- degreasing with a detergent instead of a chlorinated or volatile solvent;
- a combustible liquid such as diesel instead of petrol and kerosene which are Class 3
flammable liquids; and
- a dangerous good with a higher Packing Group number. An example is substituting
xylene (PGIII) for toluene (PGII).
· Ensure the quantity of dangerous goods kept at any one time is kept to a minimum
consistent with the operation of the premises.
Follow MSDS instructions
· Where the label or MSDS for a dangerous goods specifies measures and/or equipment to
be used for the storage and handling of the dangerous goods then you should adopt those
measures or use that equipment.
Storage and handling of packages
· Keep packages securely closed when not in use. They should be stored on surfaces that are
resistant to attack by their contents if spilt, and will not react dangerously with spilt
dangerous goods.
· Stow packages in a way that minimises the risk of them falling or being dislodged.
· Store packages so that leakage cannot adversely affect other dangerous goods in the
storage area. Liquid dangerous goods in packages should not be stored above solid
dangerous goods in paper or absorbent packaging. Glass containers of liquids should be
stored at lower levels.
· Where dangerous goods require special storage conditions to ensure their stability (ie to
eliminate the risk of hazardous reaction), make regular checks to ensure that these special
conditions are maintained. Examples of special storage conditions are the need for
stabilisers or refrigeration.
· Where aerosols are stored together in outer packaging, enclose the storage area in a strong
mesh enclosure to reduce the risk from projectiles in the event of a fire involving the
aerosols.
Transfer of dangerous goods
Where dangerous goods need to be transferred (by pumping, decanting, dispensing and
filling) into or from a container or moved from place to place in a minor storage area, ensure
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that:
· spill containment is provided that can hold at least the quantity of the largest container;
· the container being filled and any transfer equipment is earthed, if there is a likelihood of
static electricity being generated and risk from ignition of flammable vapours during the
transfer;
· the transfer is done in a manner reduces the generation of any vapours and avoids
splashing or spillage of the dangerous goods;
· the place where the transfer is carried out is:
- set aside for that purpose;
- not within the storage area but adjacent to it;
- free of ignition sources;
- free of obstructions with sufficient room to enable the transfer to be carried out and to
hold containers and associated equipment;
· any decontamination materials or clean-up equipment is kept close by;
· where dangerous goods are to be transferred into containers at the premises, the container
is suitable and can’t be damaged by the dangerous goods. For example, don’t use a plastic
container that could be softened or made brittle by the dangerous goods;
The container receiving the transferred dangerous goods as part of a work process does not
require marking.
Segregation
· Segregate any dangerous goods that are incompatible to prevent them mixing. This may be
achieved by the use of an impervious barrier or by a separation distance sufficient to
prevent contamination (a distance of 1.5 metres should be sufficient in most
circumstances).
· Section 9.1.3 of the ADG Code provides advice on the compatibility of dangerous goods.25
Separation
You must provide separation of the dangerous goods from people or property at or beyond the
boundaries of the premises. For guidance on separation of dangerous goods, refer to section
18.5(e) on isolation.
Avoid sources of heat and ignition
· Keep ignition sources away from flammable or combustible dangerous goods (dangerous
25 Examples of dangerous goods which are incompatible and which should be segregated are:
- Class 5.1 oxidising agents from Class 2.1 flammable gases, Class 3 flammable liquids, C1
combustible liquids from Class 4.1 flammable solids (fire and explosion hazard);
- concentrated acids from alkalis (reaction hazard);
- cyanides from acids (generation of toxic gas hazard); and
- calcium hypochlorite from isocyanurate pool chlorine products (reaction and fire hazard).
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goods class or subsidiary risk of 2.1, 3, 4.1, 4.2, 4.3 or combustible liquids). Naked flames
from direct fired heaters and any flames associated with maintenance work should be kept
at least 5 metres from the goods.
· Store dangerous goods away from sources of heat (for example, heating appliances).
· Where dangerous goods being stored or handled can generate flammable or explosive
atmospheres, use electrical equipment that is intrinsically safe or flameproof.
Spill control and clean-up
· Prevent any potential flow of dangerous goods to other parts of the premises that could
create a risk or reach any watercourse or the property boundary. Possible means are
bunding, provision of channels and utilising the slope of the land. Where spill containment
is required, it should have a sufficient capacity to contain the dangerous goods spillage.
· Keep equipment and materials for clean up at the premises to cope with spills from the
largest packages kept at the premises.
· Immediately clean up any spills and leaks. Contaminated, spilt or leaked goods should not
be returned to their original packaging except for the purposes of disposal or where it is
known that this will not increase the risk.
· Safely dispose of waste generated after the clean up of a spill or leak.
Decommissioning
· Ensure that any container or piece of equipment that has been used to store or handle
dangerous goods, and which is no longer required for that purpose, is cleaned free of
dangerous goods or otherwise made safe.
Ventilation
· Provide the areas in which dangerous goods are stored and handled with adequate natural
or mechanical ventilation sufficient to prevent the generation of a flammable or harmful
atmosphere. The level and type of ventilation will depend on the nature of the goods and
whether they are being stored or used. Ventilation is not required where the documented
assessment of the risks indicates that the likelihood of the release of flammable or harmful
dangerous goods into the atmosphere in the storage area is negligible.
· If you intend to rely on natural ventilation and need to install vents to achieve the
necessary airflow to maintain a safe atmosphere in the room being ventilated you should
consider the following:
- The need to provide vents at floor level and near the ceiling. Most dangerous goods
gases and vapours are heavier than air and will vent through the floor level vents. The
high level vents allowing fresh air to circulate into the room.
- The need to ventilate directly to the outside and not into another room.
- The need to provide a minimum amount of vent area and the spacing of vents to ensure
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effective airflow. A useful guide is to allow at least 1 square meter of vent area for each
50 square meters of floor area. The actual amount of vent area and the number of vents
that should be provided will be dependent on the size of the room to be vented and
whether there are restrictions to the free circulation of the air within the room.
Lighting
· Provide sufficient lighting of areas where dangerous goods are stored and handled to allow
normal work to be undertaken safely.
Security
· Secure storage areas for dangerous goods against unauthorised entry.
Personal protective equipment
· Ensure PPE, appropriate to the goods being handled, is worn when people are handling
dangerous goods.
· Periodically check and maintain any PPE provided. Refer to Section 18.5 for additional
guidance.
Access and egress
· Don’t store dangerous goods where they could hinder escape from the building or area in
the event of a fire, spill or leak.
Fire prevention
· Keep areas in which dangerous goods are stored or handled clear of combustible matter
and refuse. In the case of storage or work outdoors, the surrounding area should be cleared
of combustible vegetation for a distance of at least 3 metres.
40. Fire protection
A supply of water should be available, at a nearby location for emergency use.
In addition to building fire protection, provide portable fire extinguishers appropriate to the
type and quantity of dangerous goods being stored and handled at or near to the place where
the dangerous goods are stored or handled.
Maintain all fire protection equipment in an operable condition.
41. Emergency procedures
Establish procedures for responding to all emergencies, taking account of:
- the nature and quantity of dangerous goods;
- the types and likelihood of emergencies;
- the fire protection and other emergency equipment provided;
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- the physical features of the site;
- access to the premises; and
- the number of people on the premises and adjoining premises.
Ensure that all relevant emergency contact telephone numbers are displayed in a prominent
location at the premises.
42. Consultation, information and training
You have duties regarding consultation, information and training. Refer to section 14 and
section 28 for further guidance.
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dangerous act 1985 RETAILERS DUTIES
29. Introduction
This Part of the Code provides guidance to occupiers who are retailers. It applies only to
dangerous goods in consumer packages that are:
· on display at retail outlets and are for sale to the general public; or
· kept in transit storage in areas of the retail outlet after they are unloaded from transport
vehicles and before they are displayed for sale.
It does not apply to dangerous goods in bulk containers that are stored and handled at retail
outlets.
What is a consumer package?
A “consumer package” means a container of a net capacity that is readily available through
retail outlets for household consumption or consumption by an occasional user. It is a package
that a manufacturer or supplier has identified as suitable for use in all market sectors.
The inner packaging quantities cited in table 1.1 and 1.2 of the ADG Code would all fall
within the commonly understood meaning of consumer package but do not restrict the
application of the term.
Examples of consumer packages are:
· “pool chemicals” such as granulated chlorine (class 5.1) – widely available in packages
having a net quantity of up to 10 kilograms;
· sodium hypochlorite solutions (class 8 PG II) – when marketed as a “pool chemical’ the
containers can have a capacity of up to 20 litres;
· ammonium nitrate fertilisers (class 9), which are widely available in a net quantity up to 25
kilograms.
30. Relationship with other Parts of this Code
If this Part of the Code applies to your premises, you may choose to follow the guidance in
this Part without the need to refer to Part 3 of this Code (except where noted).
31. MSDS
You are not required to obtain an MSDS for dangerous goods in consumer packages that are
intended for retail sale unless the consumer packages are opened on the premises. However,
you may choose to act by arrangement with your suppliers to distribute MSDS. This would be
particularly appropriate for trade sale outlets.
For those dangerous goods for which an MSDS has not been obtained, you must have
alternative relevant health and safety information readily accessible. This information may be
in the form of generic MSDS, health and safety information provided by the manufacturer or
supplier, and publications produced by industry organisations. It should enable employees and
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emergency services authority personnel to deal with incidents such as spillages and damaged
consumer packages.
32. Risk management for retail situations
32.1 Hazard identification
It is sufficient compliance with regulation 404 for you to prepare a list of all of the types of
dangerous goods that are kept at the retail outlets. The list must include the name of each of
the dangerous goods, the Class, Subsidiary Risk and Packing Group of each of the dangerous
goods.
32.2 Risk assessment
It is sufficient compliance with regulation 405 for you to document the following broad types
of risks associated with the storage and handling of dangerous goods at the premises:
· fire and explosion risks associated with the storage and handling of flammable liquefied
gases (Class 2.1 or Subsidiary Risk 2.1), flammable liquids (Class 3 or Subsidiary Risk 3)
and dangerous goods of Class 4.1, 4.2 and 4.3 or Subsidiary Risk 4.1, 4.2 or 4.3.
· fire risks that may result from the storage and handling of oxidising agents of Class 5.1 or
Subsidiary Risk 5.1 or organic peroxides of Class 5.2.
· the toxic risks associated with dangerous goods of Class 6.1 or Subsidiary Risk 6.1.
· the corrosive risks associated with dangerous goods of Class 8 or Subsidiary Risk 8.
32.3 Risk control for goods on display
To control risk associated with dangerous goods in the display area:
· Ensure packages are marked in accordance with the ADG Code (unless the dangerous
goods are placed in a container provided by the purchaser).
· Keep dangerous goods away from other retail goods, such as food or personal products,
that could be contaminated in the event of leakage. This may be achieved by the use of an
impervious barrier or by a separation distance sufficient to prevent contamination (a
distance of 1.5 metres should be sufficient in most circumstances).
· Keep dangerous goods away from incompatible products. For example, swimming pools
chlorine (calcium hypochlorite) should be kept away from any oils, flammable and
combustible liquid. In addition isocyanurate pool chlorine and hypochlorite pool chemicals
can react violently together and must be kept separate. Section 9.1.3 of the ADG Code
provides advice on the compatibility of dangerous goods.
· Don’t store packages of liquid dangerous goods above solid dangerous goods in paper or
absorbent packaging.
· Stow packages in a way that will prevent the packages from falling or being dislodged and
being damaged.
· Do not open packages of dangerous goods on the premises. Exceptions to this would be for
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tinting of paint for immediate sale and customer testing of the contents of the packages.
· If dangerous goods are dispensed into containers provided by the customer (for example,
mineral turpentine, kerosene or LP Gas), you should ensure that all aspects of the filling
operation comply with:
- AS 1940 The storage of flammable and combustible liquids if the dangerous goods are
flammable or combustible liquids;
- AS 1596 Storage and handling of LP Gas if the dangerous goods are LP Gas. (Refer to
section 11 of this Code for further guidance on filling gas cylinders.)
· Immediately clean up any spillage of dangerous goods in a safe manner.
· Ensure equipment and sufficient quantities of materials for absorbing, neutralising or
decontaminating spills from the largest packages on the premises are kept at the premises.
(Spill containment should not be needed unless the quantity of dangerous goods that may
spill on any one occasion could create a risk in other parts of the premises or beyond the
premises. Catchment for firefighting effluent is not required.)
· Keep ignition sources away from the areas where flammable or combustible dangerous
goods are kept. Naked flames from direct fired heaters and any flames associated with
maintenance work should be kept at least 5 metres from the goods.
· In addition to any fire protection measures provided for the premises as a retail outlet,
additional fire extinguishers suitable for use with the dangerous goods may be required.
You should seek advice from the emergency services authority.
32.4 Risk control in storages areas
If dangerous goods in consumer packages are kept in storage areas after being unloaded from
transport vehicles and before being moved to the display area, refer to the guidance in section
20.1 ‘Transit Storage’.
33. Placarding of the premises
Your premises must be placarded if the quantity of all dangerous goods at the premises
exceeds the “Placarding Quantity” in Schedule 2 to the Regulations. Refer to section 22 in
Part 3.
For packaged dangerous goods in display areas, it is sufficient to place placards at the entry
point into the building and area where the dangerous goods are being displayed.
34. Incidents and emergency management
You must establish a system for investigating every incident that occurs at the premises. Refer
to section 25 ‘Responding to an emergency’ for further guidance.
35. Consultation, information and training
You have duties regarding consultation, information and training. Refer to sections 14 and 28
in Part 3.
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36. Keeping larger quantities of dangerous goods
If the quantity of dangerous goods at the premises exceeds the “Manifest Quantity” in
Schedule 2 of the Regulations, you must:
· prepare a manifest (refer to section 21.1);
· prepare a written emergency plan (refer to section 24.1); and
· notify WorkCover.