pharmaceutical store management system

ORGANIZATION AND MANAGEMENT
4.1 The distributor or the organization, to which the distributor belongs, must be an entity
that is appropriately authorized to perform the intended function in terms of the
applicable legislation, and which can be held liable for its activities.
4.2 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.
4.3 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.
4.4 Managerial and technical personnel must have the authority and resources needed to
carry out their duties and to set up and maintain a quality management system, as well
as to identify and correct deviations from the quality management system.
4.5 The responsibilities placed on any one individual should not be so extensive as to
present any risk to product quality.
4.6 There should be arrangements in place to ensure that management and personnel are not
subject to commercial, political, financial and other pressures or conflicts of interest that
may have an adverse effect on the quality of service provided.
4.7 Individual responsibilities should be clearly defined and understood by the individuals
concerned and recorded as written job descriptions. Certain activities may require
special attention such as the supervision of performance of activities, in accordance
with local legislation.
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4.8 Some duties may be delegated or contracted out to suitably designated persons or
entities as necessary. There should, however, be no gaps or unexplained overlaps with
regard to the application of GDP. These activities should be documented in quality
agreements or contracts. There should be periodic audit of such activities with regards
to application of GDP.
4.9 Safety procedures relating to all relevant aspects including, for example, the safety of
personnel and property, environmental protection and product integrity, should be in
place.
[Note from WHO Secretariat:
We have received an additional comment - received after the consultation discussing all
comments received within the deadline:
The proposal is to replace 4.6-4.8 by the following paragraph:
4.6 Management is responsible for ensuring that distribution practices are put into
place to ensure conformance to these GDPs and will take appropriate measure to
periodically verify that such procedures are followed to achieve the assurance of
quality intended by these GDPs."
In addition it is suggested to delete the paras 4.6-4.8 as it is considered that this exceeds
the scope of this document.
Please kindly comment.]
5. PERSONNEL
5.1 All personnel involved in distribution activities should be trained in the requirements of
GDP and be capable of meeting these requirements.
5.2 Key personnel involved in the distribution of pharmaceutical products should have the
ability and experience appropriate to their responsibility for ensuring that
pharmaceutical products are distributed properly.
5.3 There should be an adequate number of competent personnel involved in all stages of
the distribution of pharmaceutical products in order to ensure that the quality of the
product is maintained.
5.4 National regulations with regard to qualifications and experience of personnel should be
followed.
5.5 Personnel should receive initial and continued training relevant to their tasks, including
assessment as applicable, in accordance with a written training programme.
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page 12
5.6 Personnel dealing with hazardous pharmaceutical products (such as highly active, and
radioactive materials, narcotics, and other hazardous, sensitive and/or dangerous
pharmaceutical products, as well as products presenting special risks of abuse, fire or
explosion) should be given specific training.
5.7 Records of all training should be kept.
5.8 Personnel involved in the distribution of pharmaceutical products should wear working
or protective garments suitable for the activities that they perform. Personnel dealing
with hazardous pharmaceutical products, including products with materials (such as
highly active, toxic, infectious or sensitizing products) should be provided with
protective garments as necessary.
5.9 Procedures relating to personnel hygiene relevant to the activities to be carried out
should be established and observed. Such procedures should relate to health, hygiene
and clothing of personnel.
5.10 First-aid procedures and equipment for dealing with emergencies involving personnel
should be available.
5.11 Procedures and conditions of employment for employees, including contract and
temporary labour, and other personnel having access to pharmaceutical products must
be designed and administered to assist in minimizing the possibility of such products
coming into unauthorized possession.
5.12 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.
6. QUALITY MANAGEMENT
6.1 Within an organization, quality assurance serves as a management tool. In contractual
situations quality assurance also serves to generate confidence in the supplier. There
should be a documented quality policy describing the overall intentions and policies of
the distributor regarding quality, as formally expressed and authorized by management.
6.2 Quality management should include:
- an 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”.
6.3 The system should at least cover the principles of quality assurance as embodied in the
WHO guidelines on GMP for pharmaceutical products: main principles.
Working document QAS/04.068/Rev.2
page 13
6.4 All parties involved in the distribution of pharmaceutical products should share
responsibility for the quality and safety of products to ensure that they are fit for their
intended use.
6.5 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
pharmaceutical products.
6.6 Authorized procurement and release procedures should be in place, to ensure that
appropriate pharmaceutical products are sourced from approved suppliers and
distributed by approved entities.
6.7 All entities in the supply chain should be traceable as applicable, depending on the type
of product, and on the national policies and legislation. There should be written
procedures and records to ensure traceability of the products distributed.
6.8 Inspection and certification of compliance with a quality system (such as the applicable
International Standardization Organization (ISO) series, or national or international
guidelines) by external bodies is recommended. Such certification should not, however,
be seen as a substitute for compliance with these guidelines and the applicable
principles of GMP relating to pharmaceutical products.
6.9 Authorized SOPs for all administrative and technical operations performed should be in
place.
7. PREMISES, WAREHOUSING AND STORAGE
7.1 Good storage practice (GSP) is applicable in all circumstances where pharmaceutical
products are stored throughout the distribution process. For additional guidance relating
the general principles of storage of pharmaceutical products, refer to the WHO
guideline on good storage practices (WHO Expert Committee on Specifications for
Pharmaceutical Preparations. Thirty-seventh Report. Geneva, World Health
Organization, 2003 (WHO Technical Report Series, No. 908, Annex 9)).
Storage areas
7.2 Precautions must be taken to prevent unauthorized persons from entering storage
areas.
7.3 Storage areas should be of sufficient capacity to allow the orderly storage of the
various categories products, namely bulk and finished products, products in
quarantine, and released, rejected, returned or recalled products.
7.4 Storage areas should be designed or adapted to ensure good storage conditions. In
particular, they should be clean and dry and maintained within acceptable
temperature limits. Where special storage conditions are required on the label
(e.g. temperature, relative humidity), these should be provided, checked,
Working document QAS/04.068/Rev.2
page 14
monitored and recorded. Pharmaceutical products should be stored off the floor
and suitably spaced to permit cleaning and inspection. Pallets should be kept in a
good state of cleanliness and repair.
7.5 Storage areas should be clean, and free from accumulated waste and vermin. A
written sanitation programme should be available indicating the frequency of
cleaning and the methods to be used to clean the premises and storage areas.
There should also be a written programme for pest control. The pest-control
agents used should be safe, and there should be no risk of contamination of the
materials and pharmaceutical products. There should be appropriate procedures
for the clean up of any spillage to ensure complete removal of any risk of
contamination.
7.6 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.
7.7 Where quarantine status is ensured by storage in separate areas, these areas must
be clearly marked and their access restricted to authorized personnel. Any system
replacing physical quarantine should provide equivalent security. For example,
computerized systems can be used, provided that they are validated to
demonstrate security of access.
7.8 If sampling is performed in the storage area, it should be conducted in such a way
as to prevent contamination or cross-contamination. Adequate cleaning
procedures should be in place for the sampling areas.
7.9 Physical or other equivalent validated (e.g. electronic) segregation should be
provided for the storage of rejected, expired, recalled or returned products. The
products, and areas concerned should be appropriately identified.
7.10 Radioactive materials, narcotics and other hazardous, sensitive and/or dangerous
pharmaceutical products, as well as products presenting special risks of abuse, fire
or explosion, (e.g. combustible liquids and solids and pressurized gases) should be
stored in a dedicated area that is subject to appropriate additional safety and
security measures.
7.11 Pharmaceutical products should be handled and distributed according to GMP as
defined in this document.
7.12 Pharmaceutical products should be handled and stored in such a manner as to
prevent contamination, mix-ups and cross-contamination.
7.13 A system should be in place to ensure that pharmaceutical products due to expire
first are sold and/or distributed first (FEFO). Where no expiry dates exist for the
products, the FIFO principle should be applied. Exceptions may be permitted as
Working document QAS/04.068/Rev.2
page 15
appropriate, provided that adequate controls are in place to prevent the
distribution of expired products.
7.14 Rejected pharmaceutical products should be identified and controlled under a
quarantine system designed to prevent their use until a final decision is taken on
their fate.
7.15 Narcotic drugs should be stored in compliance with international conventions, and
national laws and regulations on narcotics.
7.16 Broken or damaged items should be withdrawn from usable stock and separated.
7.17 Storage areas should provide adequate lighting to enable all operations to be
carried out accurately and safely.
Storage conditions
7.18 Storage conditions for pharmaceutical products should be in compliance with the
labelling, which is based on the results of stability testing.
Monitoring of storage conditions
7.19 Recorded temperature monitoring data should be available for review. The
equipment used for monitoring should be checked at suitable predetermined
intervals and the results of such checks should be recorded and retained. All
monitoring records should be kept for at least the shelf-life of the stored material
or product plus one year, or as required by national legislation. Temperature
mapping should show uniformity of the temperature across the storage facility. It
is recommended that temperature monitors be located in areas that are most likely
to show fluctuations.
7.20 Equipment used for monitoring should also be calibrated at defined intervals.
Documentation: written instructions and records
7.21 Permanent information, written or electronic, should exist for each stored product
indicating recommended storage conditions, any precautions to be observed and
retest dates. Pharmacopoeial requirements and current national regulations
concerning labels and containers should be respected at all times.
7.22 Procedures should be in place for temperature mapping, security services at the
warehouse, destruction of unsaleable stocks and on retention of the records.
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page 16
Stock rotation and control
7.23 Periodic stock reconciliation should be performed by comparing the actual and
recorded stocks.
7.24 All significant stock discrepancies should be investigated as a check against
inadvertent mix-ups and/or incorrect issue.
8. VEHICLES AND EQUIPMENT
8.1 Vehicles and equipment used to distribute, store, or handle pharmaceutical products
should be suitable for their use and appropriately protective of the products to prevent
exposure to conditions that could affect their stability and packaging integrity, and
prevent contamination of any kind.
8.2 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.
8.3 Dedicated vehicles and equipment should be used, where possible, when handling
pharmaceutical products.
8.4 Where non-dedicated vehicles and equipment are used, procedures must be in place to
ensure that the quality of the pharmaceutical product will not be negatively influenced.
Appropriate cleaning should be performed, checked and recorded.
[Note from WHO Secretariat:
We have received an additional comment - received after the consultation discussing all
comments received within the deadline:
It is suggested to delete the paras 8.3-8.4 as in the commenter's opinion the use of
dedicated equipment and vehicles exceed the standard now adhered for drug processing
equipment.
Please kindly comment.]
8.5 Defective vehicles and equipment should not be used, and should either be removed or
labelled as such.
8.6 There should be procedures in place for the operation and maintenance of all vehicles
and equipment involved in the distribution process, including cleaning and safety
precautions.
Working document QAS/04.068/Rev.2
page 17
8.7 Vehicles, containers and equipment should be kept clean and dry and free from
accumulated waste. A written cleaning programme should be available, indicating the
frequency of cleaning and the methods to be used.
8.8 Vehicles, containers and equipment should be kept free from rodents, vermin, birds and
other pests. There should also be written programmes for such pest control. Cleaning
and fumigation agents should not have an adverse effect on product quality.
8.9 Equipment used for the cleaning of vehicles should be chosen and used so as not to
constitute a source of contamination.
8.10 Special attention should be given to the design, use, cleaning and maintenance of all
equipment used for the handling of pharmaceutical products which are not in a
protective shipping carton or case.
8.11 Where special storage conditions (e.g. temperature and/or relative humidity), different
from or limiting the expected environmental conditions, are required during transit these
should be provided, checked, monitored and recorded. All monitoring records should be
kept for a minimum of the shelf-life of the product distributed plus one year, or as
required by national legislation. Recorded monitoring data should be reviewed on
receipt of pharmaceutical products to assess whether required storage conditions have
been met.
8.12 Equipment used for monitoring conditions within vehicles and containers, e.g.
temperature and humidity, should be calibrated.
8.13 Vehicles and containers should be of sufficient capacity to allow orderly storage of the
various categories of pharmaceutical products during transportation.
8.14 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. Such goods must be securely packaged, clearly labelled, and be
accompanied by appropriate supporting documentation.
8.15 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.
9. CONTAINERS AND CONTAINER LABELLING
9.1 All pharmaceutical products should be stored and distributed in containers which do not
have an adverse effect on the quality of the products, and which offer adequate
protection from external influences, including microbial contamination.
9.2 Labels applied to containers should be clear, unambiguous, permanently fixed to the
container and be indelible. Information on the label should comply with applicable
Working document QAS/04.068/Rev.2
page 18
national legislation with regard to the labelling of containers. The labelling should be
written in at least one language which is understood by persons involved in the
distribution chain.
[Note from WHO Secretariat:
We have received an additional comment - received after the consultation discussing all
comments received within the deadline:
It is suggested to delete the paras 9.1. and 9.2 as in the commenter's opinion paragraph
13.1 (repackaging) sufficiently addresses the issue.
Please kindly comment.]
9.3 Shipping containers may not need not to bear labels with full description of the identity
of the container's content (in order to prevent theft), but should nonetheless provide
sufficient information on handling and storage conditions and precautions to ensure the
product is properly handled at all times.
9.4 Special transport and/or storage conditions should be stated on the label. If a
pharmaceutical product is intended for transfer outside the control of the
manufacturer’s products management system, the name and address of the
manufacturer, special transport conditions and any special legal requirements
including safety symbols should also be included on the label.
9.5 When used, only internationally and/or nationally accepted abbreviations, names or
codes should be used in the labelling of containers.
9.6 Special care should be used when using dry ice in containers. In addition to safety
issues 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.
9.7 Written procedures should be available for the handling of damaged and/or broken
containers. Particular attention should be paid to potentially toxic and hazardous
products
10. DISPATCH
10.1 Pharmaceutical products should only be sold and/or distributed to persons or entities
that are entitled to acquire such products in terms of applicable national, regional and
international legislation. Written proof of such authority must be obtained prior to the
dispatch of products to such person or entities.
10.2 The supplier of pharmaceutical products should, prior to the dispatch of such products,
ensure that the person or entity, e.g. the contract acceptor for transportation of the
pharmaceutical products, is aware of and follows the appropriate storage and transport
conditions.
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10.3 The dispatch and transport of pharmaceutical products should be commenced only after
the receipt of a valid delivery order or material replenishment plan which should be
documented.
10.4 Written procedures for the dispatch of pharmaceutical products should be established.
Such procedures should take into account the nature of the product, as well as any
special precautions to be observed.
10.5 Records for the dispatch of pharmaceutical products should be prepared and should
include at least the following information:
- date of dispatch;
- name and address of the entity responsible for the transportation
- name, address and status of the addressee (e.g. retail pharmacy, hospital,
community clinic);
- a description of the products including, e.g. name, dosage form and
strength (if applicable);
- quantity of the products, i.e. number of containers and quantity per container;
- assigned batch number and expiry date;
- applicable transport and storage conditions; and
- a unique number to allow identification of the delivery order.
10.6 Records of dispatch should contain enough information to enable traceability of the
pharmaceutical product. Such records should facilitate the recall of a batch of a product
as necessary. Each party involved in the distribution chain has a responsibility to ensure
traceability.
10.7 Methods of transportation, including vehicles to be used, should be selected with care,
and local conditions should be considered, including the climate of the region and any
seasonal variations experienced. Delivery of products requiring controlled temperatures
should be done in accordance with the storage and transport conditions.
10.8 Delivery schedules should be established and route planning performed where needed,
taking local needs and conditions into account. Such schedules and plans should be
realistic and systematic. Care should be taken that the volume of pharmaceutical
products ordered should not exceed the capacity of storage facilities at the destination.
10.9 Where applicable vehicles and containers should be loaded carefully and systematically
on a first-out/last-in basis in order to save time when unloading and to prevent physical
damage. Extra care should be taken during loading and unloading of cartons to avoid
breakage.
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10.10 Pharmaceutical products should not be supplied or received 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 consumer.
11. TRANSPORTATION AND PRODUCTS IN TRANSIT
11.1 The manufacturer should communicate all relevant conditions for storage and
transportation to the entity(-ies) responsible for the transportation of
pharmaceutical products. Such an entity(-ies) should ensure adherence to these
requirements throughout transportation and at any intermediate storage stages.
11.2 Pharmaceutical products should be stored and transported in accordance with
procedures in such a way that:
(a) the identity of the product is not lost;
(b) the product does not contaminate and is not contaminated by other products;
(c) adequate precautions are taken against spillage, breakage, misappropriation and
theft; and
(d) appropriate temperature and relative humidity conditions are maintained in the
case of pharmaceutical products, as appropriate, e.g. using cold chain for
thermolabile products.
11.3 The required storage conditions for pharmaceutical products should be maintained
within acceptable limits during transportation. The specific storage conditions of the
product should thus not be grossly exceeded, or exceeded for an unacceptable period of
time during the transit period. Any deviations from storage conditions which are
considered to be acceptable should be determined in consultation with the marketing
authorization holder and/or the manufacturer.
11.4 Where special conditions are required during transportation which are different from or
limit the given environmental conditions (e.g. temperature, humidity) these should be
provided, monitored and recorded.
11.5 The transportation process should not have a negative effect on the integrity and quality
of pharmaceutical products.
11.6 Written procedures should be in place to investigate and deal with any violations of
storage requirements, e.g. temperature violations.
11.7 Products comprising highly active and radioactive materials, other dangerous drugs and
substances presenting special risks of abuse, fire or explosion (e.g. combustible liquids,
solids and pressurized gases) should be stored and transported in safe, dedicated and
secure areas, containers and vehicles. In addition, applicable international agreements
and national legislation should be followed.
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page 21
11.8 Products containing narcotics and other dependence-producing substances should be
stored and transported in safe and secure areas, containers and vehicles. In addition,
applicable international agreements and national legislation should be applied.
11.9 Spillages should be cleaned as soon as possible to prevent possible contamination,
cross-contamination and hazards. Written procedures should be in place for the
handling of such occurrences.
11.10 Physical or other equivalent (e.g. electronic) segregation should be provided for the
storage and distribution during transit of rejected, expired, recalled or returned
pharmaceutical products and suspected counterfeits. The products should be
appropriately identified, securely packaged, clearly labelled, and be accompanied by
appropriate supporting documentation.
11.11 Products containing toxic and/or flammable substances should be stored and transported
in suitably designed, separate and closed containers, taking into account national
legislation and international agreements.
11.12 The interior of vehicles and containers should remain clean and dry whilst
pharmaceutical products are in transit.
11.13 Packaging materials and transportation containers should be suitable to prevent damage
of pharmaceutical products during transport.
11.14 Sufficient security should be provided to prevent theft and other misappropriation of
products. Steps should be taken to prevent unauthorized access to pharmaceutical
products being transported.
11.15 General international requirements regarding safety, health and environmental aspects
(e.g. explosion, contamination of the environment, etc.) should be observed.
11.16 Damage to containers and any other event or problem which occurs during transit must
be recorded and reported to the relevant department, entity or authority, and
investigated.
11.17 A batch tracking system should be used which enables specific batches transported to
be traced during the distribution process.
11.18 Pharmaceutical products in transit must be accompanied by the appropriate
documentation.
12. DOCUMENTATION
12.1 Written instructions and records should be available which document all activities
relating to the distribution of pharmaceutical products, including all applicable receipts
and issues. The name of the applicable entity should appear on all relevant documents.
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12.2 Procedures should be established and maintained for the preparation, review, approval,
use of and control of changes to all documents relating to the distribution process.
Procedures must be in place for both internally generated documents and documents
from external sources.
12.3 Documents, in particular instructions and procedures relating to any activity that could
have an impact on the quality of pharmaceutical products, should be designed,
completed, reviewed and distributed with care.
12.4 The title, nature and purpose of each document should be clearly stated. The contents of
documents should be clear and unambiguous. Documents should be laid out in an
orderly fashion and be easy to check.
12.5 All documents should be completed, approved, signed (as required) and dated by an
appropriate authorized person(s) and should not be changed without the necessary
authorization.
12.6 There should be compliance with national legislative requirements with regard to the
nature, content and retention of documentation, relating to the distribution of
pharmaceutical products. Where such requirements are not in place the documents
should be retained for a period equal to the shelf-life of the products where applicable,
plus one year.
12.7 The distributor must establish and maintain procedures for the identification, collection,
indexing, retrieval, storage, maintenance, disposal of and access to all applicable
documentation.
12.8 All records must be readily retrievable, stored and retained using facilities that provide a
suitable environment to prevent modification, damage, deterioration and/or loss of
documentation.
12.9 Documents should be reviewed regularly and kept up to date. When a document has
been revised a system should exist to prevent inadvertent use of the superseded version.
12.10 Mechanisms should exist to allow for transfer of information, including quality or
regulatory information between a manufacturer and a customer, as well as the transfer
of information to the relevant regulatory authority as required.
12.11 Records relating to storage of pharmaceutical products should be kept and be readily
available upon request in accordance with the WHO guideline on good storage practice
(WHO Expert Committee on Specifications for Pharmaceutical Preparations. Thirtyseventh
Report. Geneva, World Health Organization, 2003 (WHO Technical Report
Series, No. 908, Annex 9)).
12.12 In the case of temperature-sensitive pharmaceutical products, records of investigations
and actions should be retained for at least one year after the expiry date of the product.
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12.13 Where the records are generated and kept in electronic form, their back-ups should, be
available to prevent any accidental data loss.
13. REPACKAGING AND RELABELLING
13.1 Repackaging (including relabelling) of pharmaceutical products should only be
performed by distributors appropriately authorized and/or licensed to do so, and in
accordance with GMP principles. Where these functions are performed they should be
done in compliance with the applicable national, regional and international guidelines
relating to repackaging and relabelling of pharmaceutical products.
14. COMPLAINTS
14.1 There should be a written procedure in place for the handling of complaints. A
distinction should be made between complaints about a product or its packaging and
those relating to distribution. 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.
14.2 All complaints and other information concerning potentially defective and potentially
counterfeit pharmaceutical products should be reviewed carefully according to written
procedures describing the action to be taken, including the need to consider a recall
where appropriate.
14.3 Any complaint concerning a material defect should be recorded and thoroughly
investigated to identify the origin or reason for the complaint (e.g. repackaging
procedure, original manufacturing process, etc.).
14.4 If a defect relating to a pharmaceutical product is discovered or suspected consideration
should be given as to whether other batches of the product should also be checked.
14.5 Where necessary, appropriate follow-up action should be taken after investigation and
evaluation of the complaint.
15. RECALLS
15.1 There should be a system which includes a written procedure to recall promptly and
effectively pharmaceutical products known or suspected to be defective, with a
designated person(s) responsible for recalls.
15.2 Such procedures should be checked regularly and updated.
15.3 The original manufacturer should be informed in the event of a recall. Where a recall is
instituted by an entity other than the original manufacturer and/or marketing
authorization holder, consultation with the original manufacturer and/or marketing
authorization holder should, where possible, take place prior to a recall being instituted.
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15.4 The effectiveness of the arrangements for recalls should be evaluated at regular
intervals.
15.5 All recalled pharmaceutical products should be stored in a secure, segregated area
pending appropriate action.
15.6 Recalled pharmaceutical products should be segregated during transit and clearly
labelled as recalled products. Where segregation in transit is not possible, such goods
must be securely packaged, clearly labelled, and be accompanied by appropriate
documentation.
15.7 The storage conditions applicable to a pharmaceutical product which is subject to recall
should be maintained during storage and transit until such time as a decision has been
made regarding the product in question.
15.8 All customers and competent authorities of all countries to which a given
pharmaceutical product may have been distributed should be informed promptly of any
intention to recall the product because it is, or is suspected to be, defective.
15.9 All records should be readily available to a designated person(s) responsible for recalls.
These records should contain sufficient information on pharmaceutical products
supplied to customers (including exported products).
15.10 The progress of a recall process should be recorded and a final report issued, which
includes a reconciliation between delivered and recovered quantities of products.
16. REJECTED AND RETURNED PRODUCTS
16.1 Rejected products and those returned to a distributor should be appropriately identified
and handled in accordance with a procedure which involves at least the physical
segregation of such pharmaceutical products in quarantine in a dedicated area, or other
equivalent (e.g. electronic) segregation, in order to avoid confusion and prevent
distribution until a decision has been taken with regard to their disposition. The storage
conditions applicable to a pharmaceutical product which are rejected or returned should
be maintained during storage and transit until such time as a decision has been made
regarding the product in question.
16.2 The necessary assessment and decision regarding the disposition of such products must
be taken by a designated person. The nature of the product returned to the distributor,
any special storage conditions required, its condition and history and the time elapsed
since it was issued, should all be taken into account in this assessment. Where any
doubt arises over the quality of a pharmaceutical product it should not be considered
suitable for reissue or reuse.
16.3 Provision should be made for the proper and safe transport of returned products in
accordance with the relevant storage and other requirements.
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16.4 Provision should be made for the proper and safe transport of rejected and waste
materials prior to their disposal.
16.5 Pharmaceutical products should be destroyed where necessary in accordance with
international, national and local requirements regarding disposal of such products, and
with due consideration to protection of the environment.
16.6 Records of all returned, rejected and/or destroyed pharmaceutical products should be
kept.
17. COUNTERFEIT PHARMACEUTICAL PRODUCTS
17.1 Any counterfeit or suspected counterfeit medicines found in the pharmaceutical
supply chain should be segregated immediately from other pharmaceutical products
and recorded.
17.2 The holder of the marketing authorization, the appropriate national and/or international
regulatory bodies, as well as other relevant competent authorities, should be informed
immediately.
17.3 Such products should be clearly labelled in order to prevent further distribution or sale.
17.4 Upon confirmation of the product being counterfeit a formal decision should be taken
on the disposal of counterfeit pharmaceutical products and the decision recorded.
18. IMPORTATION
18.1 Consideration should be given to the WHO guidelines on import procedures for
pharmaceutical products (WHO Expert Committee on Specifications for Pharmaceutical
Preparations. Thirty-fourth Report. Geneva, World Health Organization, 1996 (WHO
Technical Report Series, No. 863, Annex 12)). The following aspects should be given
particular attention.
18.2 The number of ports of entry in a country for the handling of imports of pharmaceutical
products should be limited by appropriate legislation.
18.3 The most appropriately located and best equipped to handle imports of pharmaceutical
products should be chosen as the point(s) of entry when such products are imported into
a country.
18.4 At the port of entry consignments of pharmaceutical products should be stored under
suitable conditions for as short a time as possible.
18.5 All reasonable steps should be taken by importers to ensure that products are not
mishandled or exposed to adverse storage conditions at wharves or airports.
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18.6 Where necessary persons with pharmaceutical training should be involved with the
customs procedures or should be readily contactable.
18.7 The WHO Certification Scheme on the quality of pharmaceutical products moving in
international commerce should be used to provide data regarding quality assessment of
imported pharmaceutical products.
19. CONTRACT ACTIVITIES
19.1 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.
19.2 The contract should define the responsibilities of each party including observance of the
principles of GDP.
19.3 All contract accepters should comply with the requirements in these guidelines.
19.4 Subcontracting may be permissible under certain conditions subject to the written
approval of the contract giver.
19.5 Any contract accepter should be audited periodically.
20. SELF-INSPECTION
20.1 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
GDP and to trigger necessary corrective and preventive measures.
20.2 Self-inspections should be conducted in an independent and detailed way by a
designated, competent person.
20.3 All self-inspections should be recorded. Reports should contain all observations made
during the inspection and, where applicable, proposals for corrective measures. There
should be an effective follow-up programme. Management should evaluate the
inspection report, and corrective actions taken and recorded.
21. BIBLIOGRAPHY
1. WHO Expert Committee on Specifications for Pharmaceutical Preparations. Thirtyfourth
Report. Geneva, World Health Organization, 1996 (WHO Technical Report
Series, No. 863).
2. WHO Expert Committee on Specifications for Pharmaceutical Preparations. Thirtysixth
Report. Geneva, World Health Organization, 2002 (WHO Technical Report
Series, No. 902).
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3. WHO Expert Committee on Specifications for Pharmaceutical Preparations. Thirtyseventh
Report. Geneva, World Health Organization, 2003 (WHO Technical Report
Series, No. 908).
4. Guide to good storage practices for pharmaceuticals. WHO Expert Committee on
Specifications for Pharmaceutical Preparations. Thirty-seventh Report. Geneva, World
Health Organization, 2003 (WHO Technical Report Series, No. 908, Annex 9).
5. WHO Expert Committee on Specifications for Pharmaceutical Preparations. Thirtyeighth
Report. Geneva, World Health Organization, 2004 (Technical Report Series, No.
917).
6. Good trade and distribution practices for pharmaceutical starting materials. WHO
Expert Committee on Specifications for Pharmaceutical Preparations. Thirty-eighth
Report. Geneva, World Health Organization, 2004 (WHO Technical Report Series, No.
917, Annex 2).
7. Quality Assurance of Pharmaceuticals. A compendium of guidelines and related
materials, Volume 1. Geneva, World Health Organization, 1997.
8. Quality Assurance of Pharmaceuticals. A compendium of guidelines and related
materials. Good manufacturing practices and inspection, Volume 2 (updated version).
Geneva, World Health Organization, 2004.
9. Marketing Authorization of Pharmaceutical Products with Special Reference to
Multisource (Generic) Products – A Manual for a Drug Regulatory Authority. Geneva,
World Health Organization, 1999 (Regulatory Support Series, No. 5,
WHO/DMP/RGS/98.5).
10. A Model Quality Assurance System for Prequalification, Procurement, Storage and
Distribution of Pharmaceutical Products. Geneva, World Health Organization, 2003
(unpublished draft).
11. Managing Drug Supply. The selection, procurement, distribution, and use of
pharmaceuticals. Management Sciences for Health in collaboration with World Health
Organization. 2nd Ed. Connecticut, USA. Kumarian Press, Inc., 1997.
12. Guidelines on Good Distribution Practice of Medicinal Products for Human Use (94/C
63/03). European Agency for Evaluation of Medicinal Products. Directive 92/25/EEC
of 31 March 1992.
13. Australian Code of Good Wholesaling Practice for Therapeutic Goods for Human Use.
Therapeutic Goods Administration, Australia. November 1991.
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14. Current Good Manufacturing Practice in Manufacturing, Processing, Packing or
Holding of drugs and Current Good Manufacturing Practice for Finished
Pharmaceuticals. Code of Federal Regulations Parts 210 and 211. Food and Drug
Administration, USA.
15. Principles and Guidelines of Good Manufacturing Practice for Medicinal Products for
Human Use. Commission Directive 2003 794/356/EEC, 13 June 1991. European
Agency for Evaluation of Medicinal Products.
16. Guidance Document: Good Manufacturing Practice for Medicine in South Africa.
Medicines Control Council, South Africa, 2003.
17. Guide to Good Manufacturing Practices for Medicinal Products. Pharmaceutical
Inspection Convention, Pharmaceutical Inspection Co-operation Scheme, July 2004.
18. Guide to Good Manufacturing Practices for Medicinal Products. Pharmaceutical
Inspection Convention, Pharmaceutical Inspection Co-operation