Annex 6

Good trade and distribution practices for pharmaceutical

starting materials

Introduction 212
1. Quality management 213
2. Organization and personnel 214
3. Premises 215
4. Procurement, warehousing and storage 216
5. Equipment 218
6. Documentation 219
7. Repackaging and relabelling 220
8. Complaints 223
9. Recalls 223
10. Returned goods 224
11. Handling of non-conforming materials 224
12. Dispatch and transport 225
13. Contract activities 226
References 226

211
WHO Expert Committee on Specifications for Pharmaceutical Preparations Fiftieth report

Introduction
Good manufacturing practices for active pharmaceutical ingredients were
published in 2000 by The International Conference on Harmonisation of
Technical Requirements for Registration of Pharmaceuticals for Human Use
(ICH), in ICH Q7 (1). Section 17 of this ICH text includes guidelines for agents,
brokers, traders, distributors, repackers and relabellers. This section was written
based on the outcome of the World Health Organization (WHO) investigation
into deaths resulting from the intentional relabelling of industrial grade
ethylene glycol as pharmaceutical grade material. This material was subsequently
formulated into a paediatric medicine that caused many deaths. Section 17 of this
good manufacturing practice (GMP) guide for active pharmaceutical ingredients
(APIs) applies to any party other than the original manufacturer which may trade
and/or take possession, repack, relabel, manipulate, distribute or store an API or
API intermediate. The scope of ICH Q7 does not include excipients.
Following a number of incidents involving diethylene glycol and a World
Health Assembly resolution (WHA52.19), WHO published the Good trade and
distribution practices for pharmaceutical starting materials in 2004 (2). At the time
of publication of these guidelines, WHO had not yet adopted the text from ICH
Q7 as GMP for APIs. The WHO guidance for excipients (3), published in 1999,
did not cover trade and distribution practices for excipients.
In 2010, WHO published Good manufacturing practices for active
pharmaceutical ingredients (4), which reflect the text from ICH Q7 and include
Section 17 of that document, to replace the existing WHO GMP for APIs.1
The WHO Expert Committee on Specifications for Pharmaceutical
Preparations discussed the revision of the Good trade and distribution practices
for pharmaceutical starting materials at several meetings. The scope of this
WHO guidance on Good trade and distribution practices for pharmaceutical
starting materials is applicable to any ingredient that is used in the manufacture
WHO Technical Report Series No. 996, 2016

of a medicinal product, including APIs, excipients and any others.

Note: Material deriving from non-pharmaceutical grades, such as food, industrial
or technical grades, should not be designated as pharmaceutical grade when it is
not produced under the required manufacturing conditions and quality system.
For finished pharmaceutical products (FPPs), details can be found in the WHO
good distribution practices for pharmaceutical products (5).

  It is important to note that any party that engages in repackaging or blending of an API is considered to
1

be a manufacturer and must submit appropriate registration documents for such manufacturing. He or
she must also comply with the GMP for APIs as stated in WHO Technical Report Series, No. 957, Annex 2,
2010 (4).
212
Annex 6

1. Quality management
1.1 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 direction of the distributor regarding quality,
which should be formally expressed and authorized by management. The
quality policy should clearly indicate that the distributor implements and
maintains good trade and distribution practices (GTDP) as described in
these guidelines, within the organization and its services.
1.2 Quality management should include:
■■ an appropriate infrastructure or “quality system”, encompassing the
organizational structure, procedures, processes and resources. The
size, structure and complexity of the distributor and its activities
should be taken into consideration when developing or modifying
the quality system;
■■ an independent quality unit (or designee), which is responsible for
all quality-related matters;
■■ an appropriate quality risk management (QRM) system to enable a
systematic process for the assessment, control, communication and
review of risks to the quality of the product. The extent of application
of the QRM system should reflect the operations performed;
■■ a validation/qualification system to ensure that the resulting product
is capable of meeting the requirements for the specified application;
■■ systematic actions necessary to ensure adequate confidence that a
material (or service) and relevant documentation will satisfy given
requirements for quality – the totality of these actions is termed
quality assurance;
■■ a clear documented procedure for selecting, approving, disqualifying
and re-approving suppliers of pharmaceutical starting materials
and services;
■■ a robust deviation management and change control programme
designed to ensure that quality is continually assessed and
maintained: these should include a customer notification where
appropriate;
■■ a system ensuring traceability of products and associated
documentation throughout the entire supply chain.
1.3 The system should cover for example, but not be limited to, the quality
assurance principles in these guidelines.
213
WHO Expert Committee on Specifications for Pharmaceutical Preparations Fiftieth report

1.4 All parties involved in the manufacture and supply chain must exercise
responsibility to ensure the quality and safety of the materials and
products, and that they are fit for their intended use in accordance with
their specifications.

1.5 The responsibilities placed on any one individual should not be so

extensive as to present any risk to quality. In the event of a supplier
having a limited number of staff, some duties may be delegated or
contracted out to designated persons who are appropriately qualified.
There should, however, be no gaps or unexplained overlaps related to the
application of GTDP for pharmaceutical starting materials as described
in these guidelines.

1.6 Where electronic commerce (e-commerce) is used, defined procedures

and adequate systems should be in place to ensure confidence in the
quality of the material and its traceability.

1.7 Authorized release procedures should be in place to ensure that when

material is released for its intended purpose, it is of an appropriate quality,
meets its specifications and is sourced from approved suppliers.

1.8 Implementation of QRM principles using appropriate tools such as

hazard analysis and critical control point (HACCP); inspection and
certification of compliance with an appropriate quality system such as
applicable International Organization for Standardization (ISO) series,
and recognition of compliance with national and/or regional standards by
external bodies is recommended. However, this should not be seen as a
substitute for the implementation of these guidelines or for conforming,
for example, to pharmaceutical GMP and good storage practices (GSP)
requirements, as applicable.
WHO Technical Report Series No. 996, 2016

1.9 A system should be in place for the performance of regular internal audits
with the aim of continuous improvement. The findings of the audit and
any corrective and preventive actions taken, including verification of their
effectiveness, should be documented and brought to the attention of the
responsible management.

2. Organization and personnel

2.1 There should be an adequate organizational structure and a sufficient
number of personnel should be employed to carry out all the tasks for
which the supplier is responsible.
214
Annex 6

2.2 Individual responsibilities should be clearly defined, understood by

the individuals concerned and recorded in writing (as job descriptions
or in a contract). Certain activities, such as supervision of performance
of activities in accordance with local legislation, may require special
attention. Personnel should be suitably qualified, trained and authorized
to undertake their duties and responsibilities.
2.3 All personnel should be aware of the principles of the appropriate
guidelines, including but not limited to GTDP.
2.4 Personnel should receive initial and continuing training relevant to their
tasks. Training should be provided by qualified trainers in accordance with
a training programme. The effectiveness of training should be verified
where appropriate. Training records should be maintained. All personnel
should be motivated to support the establishment and maintenance of
quality standards.
2.5 Personnel dealing with hazardous materials (such as highly active, toxic,
infectious or sensitizing materials) should be given specific training and
should be provided with the necessary protective equipment. Documented
policies and procedures for the use of personal protective equipment
should be followed to decrease exposure of workers working directly with
products and those in the immediate environment.
2.6 Personnel who may be exposed to materials from open containers should
maintain good hygiene, have no open wounds and should wear appropriate
protective garments, gloves, masks and goggles.

3. Premises
3.1 Premises, including laboratory facilities, must be located, designed,
constructed, adapted and maintained to suit the operations to be carried
out. Their layout and design must aim to minimize the risk of errors and
permit effective cleaning and maintenance in order to avoid contamination,
cross-contamination, mix ups, build-up of dust, dirt or waste and, in
general, any adverse effect on the quality of materials.
3.2 Measures should be in place to prevent unauthorized persons from
entering the premises.
3.3 Premises should be designed, equipped and maintained so as to afford
maximum protection against the entry of insects, rodents or other animals.
A pest control programme should be implemented and maintained. Its
effectiveness should be monitored.
215
WHO Expert Committee on Specifications for Pharmaceutical Preparations Fiftieth report

3.4 Suitable supporting facilities and utilities (such as air control, ventilation
and lighting) should be in place and appropriate to the activities performed,
in order to avoid contamination, cross-contamination and degradation of
the material. Utilities that could affect product quality should be identified
and monitored.
3.5 If sampling of pharmaceutical starting materials is performed, the sampling
area should be separate and in a controlled environment. Sampling should
only be performed in a storage area if it can be conducted in such a way
that there is no risk of contamination or cross-contamination. Adequate
cleaning procedures should be in place for the sampling areas.

4. Procurement, warehousing and storage

Note: GSP are applicable in all circumstances in which, and in all areas where,
materials are stored.
4.1 Materials should be purchased from approved suppliers in accordance with
mutually agreed formal specifications.
4.2 Actions should be taken to minimize the risk of falsified or non-conforming
materials entering the supply chain.
4.3 There should be authorized procedures describing the activities relating
to the receipt, storage and distribution of materials. Steps should be taken
to ensure and document that the arriving consignment is correct and
that the products originate from approved suppliers. Deliveries should
be examined to check that containers have not been damaged, altered or
tampered with, and that closures and security seals are intact.
4.4 Storage areas should have sufficient capacity to allow orderly storage of
WHO Technical Report Series No. 996, 2016

the various categories of materials.

4.5 Receipt and dispatch bays should be equipped with the means to protect
materials from adverse environmental conditions. Reception areas should
be designed and equipped to allow containers of incoming materials to
be cleaned before storage if appropriate. Upon receipt, material should be
segregated until released by the quality unit.
4.6 Segregated areas should be provided for the storage of received,
quarantined, rejected, recalled and returned material, including materials
with damaged packaging. Any system replacing physical segregation, such
as electronic segregation based on a computerized system, should provide
equivalent security and should be appropriately qualified and validated.
216
Annex 6

4.7 The storage areas should be kept clean and dry.

4.8 Segregated areas and materials should be appropriately identified.
4.9 The required storage conditions, as specified for the material, should be
maintained within acceptable limits at all times during storage. Appropriate
checks to confirm that required shipping conditions have been met should
be conducted as soon as possible after receipt.
The product should be transferred to appropriate storage facilities
immediately after checks to be made in the goods receiving area have
been conducted.
4.10 Where special storage conditions are required (e.g. particular temperature,
humidity or protection from light) these should be provided, monitored
and recorded as appropriate.
4.11 Highly active materials, narcotics, other dangerous drugs and substances
presenting special risks of abuse, fire or explosion should be stored in safe,
dedicated and secure areas. In addition and where applicable, international
conventions and national legislation are to be adhered to.
4.12 Special attention should be given to the design, use, cleaning and
maintenance of all equipment for bulk handling and storage, such as tanks
and silos.
4.13 Products should be packed in such a way as to avoid breakage,
contamination, tampering or theft. The packing should be adequate to
maintain the quality of the product during transport. If special shipping
conditions have to be met they should be defined, provided and controlled.
The containers in which products are shipped should be sealed and should
clearly indicate the authenticity of the product and its supplier.
4.14 Spillages should be cleaned up as soon as possible to prevent possible
cross‑contamination and hazard.
4.15 Provision should be made for the proper and safe storage of waste
materials awaiting disposal. Toxic substances and flammable materials
should be stored in suitably designed, separate, closed containers in
enclosed areas, taking into account the relevant national legislation.
4.16 A default system should be in place to ensure that those materials due to
expire first are sold or distributed first (earliest expiry/first out). Where no
expiry dates are specified for the materials, the first in/first out principle
should be applied.
217
WHO Expert Committee on Specifications for Pharmaceutical Preparations Fiftieth report

4.17 A process should be in place to ensure that materials that have reached
their expiry or retest date should be withdrawn immediately from saleable
stock. Materials with a retest date should be retested according to the
appropriate specifications. Materials with an expiry date should not be
retested or used after that date.
4.18 Stock inventory should be checked regularly, at least for quantity, overall
condition and retesting or expiration dates. Any discrepancies should
be investigated.
4.19 Controls should be in place to ensure that the correct product is picked,
packed and distributed. The material should have an appropriate remaining
shelf life. All batch numbers should be recorded.
4.20 Storage areas should be clean and free from accumulated waste and from
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.

5. Equipment
5.1 Equipment must be located, designed, constructed, adapted, qualified,
used, cleaned and maintained to suit the operations to be carried out.
Its  layout, design and use should aim to minimize the risk of errors
and permit effective cleaning and maintenance so as to avoid cross-
contamination, build-up of dust or dirt and any adverse effect on the
quality of materials.
5.2 Defective equipment should not be used and should either be removed or
labelled as defective. Equipment should be disposed of in such a way as to
WHO Technical Report Series No. 996, 2016

prevent any misuse.

5.3 The status of the equipment should be readily identifiable.
5.4 Fixed pipework should be clearly labelled to indicate the contents and,
where applicable, the direction of flow.
5.5 All services, piping and devices should be adequately marked and special
attention paid to the provision of non-interchangeable connections or
adaptors for dangerous gases, liquids and other materials.
5.6 Balances and other measuring equipment of an appropriate range and
precision should be available and should be calibrated in accordance with
a suitable schedule.
218
Annex 6

5.7 Dedicated equipment should be used where appropriate when handling

and/or processing pharmaceutical starting materials. Where non-dedicated
equipment is used cleaning validation should be performed.
5.8 Closed equipment should be used when possible. If open equipment is
used, suitable measures should be taken to prevent contamination.
5.9 Procedures should be in place for the operation and maintenance of
equipment. Lubricants and other materials used on surfaces that come into
direct contact with the materials should be of the appropriate grade, e.g.
food-grade oil, and should not alter the quality of the materials.
5.10 Washing and cleaning equipment should be chosen and used such that it
cannot be a source of contamination.

6. Documentation
6.1 Documents, in particular instructions and procedures relating to any
activity that might have an impact on the quality of materials, should
be designed, completed, reviewed and distributed with care. Documents
should be completed, approved, signed and dated by appropriate authorized
persons and should not be changed without authorization. Specifications
for materials, including packaging materials, should be available, reviewed
and revised on a regular basis.
6.2 Documents should have unambiguous contents: their title, nature and
purpose should be clearly stated. They should be laid out in an orderly
manner and be easy to check.
6.3 Certificates of analysis (COAs) issued by the original manufacturer should
be provided. If additional testing is done, all COAs should be provided.
COAs should document product traceability back to the
manufacturer by naming the original manufacturer and the manufacturing
site. COAs should indicate which results were obtained by testing the
original material and which results came from skip-lot testing or other
testing and should specify the organization responsible for issuing the COA.
6.4 Before any material is sold or distributed, the supplier should ensure
that  the COAs and results are available and that the results meet the
required specifications.
6.5 The original manufacturer and the intermediaries handling the material
should always be traceable and transparent; and this information should
be made available to authorities and end-users, downstream and upstream,
when requested.
219
WHO Expert Committee on Specifications for Pharmaceutical Preparations Fiftieth report

6.6 Depending upon risk assessment, and in accordance with the national
requirements, quality agreements should form the basis of the relationship
for all parties involved in the supply chain. The agreements should include
mechanisms to allow transfer of information, e.g. quality or regulatory
information and change control.
6.7 Labels applied to containers should be clear, unambiguous, permanently
fixed and should be printed in the company’s agreed format. The
information on the label should be indelible.
6.8 Each container should be identified by labelling bearing at least the
following information:
–– the name of the pharmaceutical starting material (including grade
and reference to pharmacopoeias where relevant);
–– if applicable, the International Nonproprietary Name (INN);
–– the amount (weight or volume);
–– the batch number assigned by the original manufacturer or the
batch number assigned by the repacker, if the material has been
repacked and relabelled;
–– the retest date or expiry date (where applicable);
–– the storage conditions;
–– handling precautions, where necessary;
–– identification of the original manufacturing site;
–– name and contact details of the supplier.
6.9 Relevant storage and handling information and safety data sheets should
be available.
WHO Technical Report Series No. 996, 2016

6.10 Records should be kept and must be readily available upon request in
accordance with GMP and GSP (6).

7. Repackaging and relabelling

7.1 Operations, such as combining into a homogeneous batch, repackaging
and/or relabelling, are manufacturing processes and are not recommended.
In circumstances where they are to be conducted, their performance
should be in compliance with GMP.
Note: It is important to note that any party who engages in repackaging or blending
of an API is considered to be a manufacturer and must submit appropriate
220
Annex 6

registration documents for such manufacturing. They must also comply with the
GMP for APIs as set out in WHO Technical Report Series, No. 957, Annex 2,
2010 (4).
7.2 Special attention should be given to the following points:
–– prevention of contamination, cross-contamination and mix ups;
–– appropriate environmental conditions for dispensing, packaging
and sampling;
–– security of stocks of labels, line clearance checks, online inspections,
destruction of excess batch-printed labels and label reconciliation;
–– good sanitation and hygiene practices;
–– maintaining batch integrity (mixing of different batches of the same
solid material should normally not be done);
–– as part of batch records, all labels that were removed from the
original container during operations, and a sample of the new label,
should be kept;
–– if more than one batch of labels is used in one operation, samples of
each batch should be kept;
–– maintaining product identity, integrity and traceability.
7.3 Upon receipt, packaging materials should be placed in quarantine and
should not be used prior to release. There should be procedures for the
inspection, approval and release of the packaging materials.
7.4 When different batches of a material from the same original manufacturing
site are received by a distributor and combined into a homogeneous batch,
the conformity of each batch with its specification should be confirmed
before it is added.
7.5 Only materials from the same manufacturing site, received by a distributor
and conforming to the same specifications, can be mixed. If different
batches of the same material are mixed to form a homogeneous batch
it should be defined as a new batch, tested and supplied with a batch
certificate of analysis. In such cases the customer should be informed that
the material supplied is a mixture of manufacturers’ batches.
7.6 In all cases, traceability back to the manufacturer should be documented
by identifying the original manufacturer of the specific batch of the
material and its manufacturing site.
7.7 If batches are combined or mixed, the oldest batch should determine the
expiry or retest date assigned to the combined or mixed batch.
221
WHO Expert Committee on Specifications for Pharmaceutical Preparations Fiftieth report

7.8 If the integrity and quality of the batch is maintained during repackaging
and relabelling, then the original COA of the original manufacturer should
be provided.
If retesting is done, both the original and the new COA should be
provided as long as the batch integrity is maintained. The batch referred to
on the new COA should be traceable to the original COA.
7.9 Repackaging of materials should be carried out using approved packaging
materials for which the quality and suitability have been established as
being equal to or better than those of the original container.
7.10 The reuse of containers should be discouraged unless they have been
cleaned using a validated procedure. Recycled containers should not be
used unless there is evidence that the quality of the material packed in
them will not be adversely affected.
7.11 Materials should be repackaged only if efficient environmental control
exists to ensure that there is no possibility of contamination, cross-
contamination, degradation, physicochemical changes and/or mix ups.
The quality of air supplied to the area should be suitable for the activities
performed, e.g. there should be efficient filtration.
7.12 Suitable procedures should be followed to ensure proper label control.
7.13 Containers of repackaged material and relabelled containers should bear
both the name of the original manufacturing site and the name of the
distributor/repacker.
7.14 Procedures should be in place to ensure maintenance of the identity
and quality of the material by appropriate means, both before and after
repackaging operations.
WHO Technical Report Series No. 996, 2016

7.15 Each batch of repackaged material should be tested to ensure that the
material conforms to documented specifications.
7.16 There should be a procedure to ensure that appropriate repackaging
documentation, in addition to the test results, is evaluated prior to release
of the repackaged material.
7.17 Sampling, analytical testing and batch release procedures should be in
accordance with GMP.
7.18 Only official pharmacopoeial methods or validated analytical test methods
should be used for the analysis. Where alternatives to the test methods
specified in a monograph are used to provide test results, those alternative
methods should be demonstrated to be suitable and equivalent.
222
Annex 6

7.19 Out-of-specification test results should be investigated and documented.

7.20 Samples of pharmaceutical starting materials in appropriate quantities

should be kept for at least one year after the expiry or retest date, or for
three years after distribution is complete.

7.21 The repacker and relabeller should ensure that the stability of the material
is not adversely affected by the repackaging or relabelling. Stability studies
to justify assigned expiration or retest dates should be conducted if the
pharmaceutical starting material is repackaged in a container different
from that used by the original manufacturer. It is recognized that some
excipients may not need additional stability studies.

8. Complaints
8.1 All complaints and other information concerning potentially defective
materials must be carefully reviewed according to written procedures
that describe the action to be taken and specify the criteria on which a
decision to recall a product should be based. Records of complaints should
be retained and evaluated for trends at defined intervals.

8.2 Any complaint concerning a material defect should be recorded and

thoroughly investigated to identify the origin or reason for the complaint
(e.g. the repackaging procedure or the original manufacturing process).
Corrective and preventive actions should be taken where appropriate,
and recorded.

8.3 If a defect in a pharmaceutical starting material is discovered or suspected,

consideration should be given to whether other batches should be checked.

8.4 Where necessary, appropriate follow-up action, possibly including a recall,

should be taken after investigation and evaluation of the complaint.

8.5 The manufacturer and customers should be informed if action is needed

following possible faulty manufacturing, packaging, deterioration or any
other serious quality problems with a pharmaceutical starting material.

9. Recalls
9.1 There should be a system for recalling promptly and effectively from the
market, materials known or suspected to be defective.

9.2 The original manufacturer should be informed in the event of a recall.

223
WHO Expert Committee on Specifications for Pharmaceutical Preparations Fiftieth report

9.3 There should be detailed written procedures for the organization of

any recall activity. These procedure(s) should be regularly reviewed
and updated.
9.4 All recalled materials should be stored in a secure area while their fate
is decided.
9.5 In the event of serious or potentially life-threatening situations, all
customers and competent authorities in all countries to which a given
material may have been distributed should be promptly informed of any
intention to recall the material.
9.6 All records should be readily available to the designated person(s)
responsible for recalls. These records should contain sufficient information
on materials supplied to customers (including exported materials).
9.7 The effectiveness of the arrangements for recalls should be evaluated at
regular intervals.

10. Returned goods

10.1 Goods returned to the supplier should be appropriately identified and
quarantined. The conditions under which returned goods have been
stored and shipped should be evaluated to determine the quality of the
returned goods.
10.2 The quality unit or designee should decide on the disposition of the
returned goods following a formal and documented investigation process.
Corrective and preventive actions should be taken where appropriate.
WHO Technical Report Series No. 996, 2016

11. Handling of non-conforming materials

11.1 Non-conforming materials should be handled in accordance with a
procedure that will prevent their introduction or reintroduction into the
market. Records covering all activities, including destruction, disposal,
return and reclassification, should be maintained.
11.2 An investigation should be performed to establish whether any other
batches are also affected. Corrective and preventive measures should be
taken where necessary.
11.3 The disposition of the material, including downgrading to other suitable
purposes, should be documented.
224
Annex 6

11.4 Non-conforming materials should never be blended with materials that

do comply with specifications.

12. Dispatch and transport

12.1 Materials should be loaded, unloaded and transported in a manner that
will ensure the maintenance of controlled conditions where applicable (e.g.
temperature, protection from the environment). The transport process
should not adversely affect the materials. Any carrier used for transport
should be approved according to a written procedure unless the carrier has
been selected by the customer.
12.2 Requirements for special transport and/or storage conditions should
be stated on the label and/or in the transport documentation. If the
pharmaceutical starting material is intended to be transferred outside the
control of the manufacturer’s materials management system, the name
and address of the manufacturer, quality of contents, special transport
conditions and any special legal requirements should also be included on
the label and/or in the transport documentation.
12.3 The supplier of the materials should ensure that the contract acceptor for
transportation of the materials is aware of and provides the appropriate
storage and transport conditions, e.g. through audits.
12.4 Procedures should be in place to ensure proper cleaning and prevention of
cross-contamination when liquids (tanks) and bulk or packed materials
are transported.
12.5 The bulk transport of pharmaceutical starting materials requires numerous
precautions to avoid contamination and cross-contamination. The best
practice is to use dedicated equipment, tanks or containers.
12.6 Packaging materials and transportation containers should be suitable to
prevent damage to the pharmaceutical starting materials during transport.
12.7 For bulk transport, validated cleaning procedures should be used between
loadings, and a list of restricted previous cargoes must be supplied to the
transport companies.
12.8 Steps should be taken to prevent unauthorized access to the materials
being transported.
12.9 General international requirements regarding safety aspects (e.g. prevention
of explosion and of contamination of the environment) should be observed.
225
WHO Expert Committee on Specifications for Pharmaceutical Preparations Fiftieth report

13. Contract activities

13.1 Any activity performed, as referenced in the GMP and GTDP guidelines,
delegated to another party, should be agreed upon in a written contract.
13.2 The contract giver should evaluate the proposed contract acceptor’s
compliance with GTDP before entering into an agreement.
13.3 All contract acceptors should comply with the requirements in these
guidelines. Special consideration should be given to the prevention of
cross-contamination and to maintaining traceability.
13.4 There should be a written and approved contract or formal agreement
between the contract giver and contract acceptor that addresses and
defines in detail the responsibilities with respect to GTDP and which
party is responsible for which quality measures.
13.5 Subcontracting may be permissible under certain conditions, subject to
approval by the contract giver, especially for activities such as sampling,
analysis, repacking and relabelling.

References
1. ICH harmonised tripartite guideline: Good manufacturing practice guide for active pharmaceutical
ingredients – Q7. Geneva: International Conference on Harmonisation of Technical Requirements
for Registration of Pharmaceuticals for Human Use; 2000.
2. Good trade and distribution practices for pharmaceutical starting materials. In: WHO Expert
Committee on Specifications for Pharmaceutical Preparations: thirty-eighth report. Geneva:
World Health Organization; 2004: Annex 2 (WHO Technical Report Series, No. 917).
3. Good manufacturing practice: supplementary guidelines for the manufacture of pharmaceutical
excipients. In: WHO Expert Committee on Specifications for Pharmaceutical Preparations: thirty-
WHO Technical Report Series No. 996, 2016

fifth report. Geneva: World Health Organization; 1999: Annex 5 (WHO Technical Report Series,
No. 885).
4. Good manufacturing practices for active pharmaceutical ingredients. In: WHO Expert Committee
on Specifications for Pharmaceutical Preparations: forty-fourth report. Geneva: World Health
Organization; 2010: Annex 2 (WHO Technical Report Series, No. 957).
5. WHO good distribution practices for pharmaceutical products. In: WHO Expert Committee
on Specifications for Pharmaceutical Preparations: forty-fourth report. Geneva: World Health
Organization; 2010: Annex 5 (WHO Technical Report Series, No. 957).
6. Guide to good storage practices for pharmaceuticals. In: WHO Expert Committee on Specifications
for Pharmaceutical Preparations: thirty-seventh report. Geneva: World Health Organization;
2003: Annex 9 (WHO Technical Report Series, No. 908).

226