The International Pharmaceutical Excipients Council

Good Distribution
Practices
Audit Guide
For Pharmaceutical Excipients

Third Version
2021

Copyright © 2021 The International Pharmaceutical Excipients Council

 This document represents voluntary guidance for the excipient industry and the contents
should not be interpreted as regulatory requirements. Alternatives to the approaches in this
Guide may be used to achieve an equivalent level of assurance for excipient quality.
This guide was created to help companies understand current expectations on this topic and is
not intended for use by third party certification bodies to conduct audits or to certify
compliance with the guide.
The content of this guide cannot be reproduced without the written authorisation of the IPEC
Federation Management Body.

FOREWORD
The International Pharmaceutical Excipients Council (IPEC) is an international industry
association formed by excipient manufacturers, distributors and users. At the current writing there
are regional pharmaceutical excipient industry associations located in the Americas, Europe,
Japan, China, and India. IPEC’s objective is to contribute to the international excipient standards
development and harmonization, provide information useful for new excipient development and
introduction, and offer best practice and guidance concerning excipient development.
IPEC has three major stakeholder groups:
1. excipient manufacturers and distributors, defined as suppliers in IPEC documents,
2. pharmaceutical manufacturers, defined as users in this document, and
3. public health and regulatory authorities.

This Guide is intended to be voluntary, to indicate best practice, and to be globally applicable.
However, it should be recognized that the rules and regulations applying to excipients will vary
from region to region and country to country. In addition, the rules and regulations are continually
evolving. It is the responsibility of users of the Guide to determine whether there are any additional
legal or regulatory requirements, in addition to the recommendation given in this Guide, applicable
to a particular region or country in which they are doing business.

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This document has been written to provide a tool for those companies auditing the supply chain
of pharmaceutical excipients.
This Audit Guide should be used in conjunction with the IPEC Good Distribution Practices Guide.
This guide is a tool to help the auditor conduct a complete audit of all relevant GDP principles for
pharmaceutical excipients.
This document is a consolidation and revision of the IPEC Europe Good Distribution Practices
Audit Guideline for Pharmaceutical Excipients 2011 [1] and the IPEC-Americas Good Distribution
Practices Audit Guide for North American Distribution of Pharmaceutical Excipients 2011 [2]

NOTE: Refer to the “International Pharmaceutical Excipients Council Glossary: General Glossary
of Terms and Acronyms” [6] for definitions. The first use of a term found in the glossary will be in
BOLD.

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Table of Contents

FOREWORD......................................................................................................................... 1
I. Introductory Note .................................................................................................... 4
II. Scope......................................................................................................................... 4
III. Pharmaceutical Grade Excipients ........................................................................ 5
IV. Acknowledgements................................................................................................. 5
1 Quality Management................................................................................................. 7
2 Organisation and Personnel ................................................................................. 11
3 Premises................................................................................................................... 15
4 Procurement, warehousing and storage............................................................. 17
5 Equipment ................................................................................................................ 22
6 Documentation ........................................................................................................ 25
7 Repackaging and relabeling.................................................................................. 28
8 Complaints ............................................................................................................... 34
9 Recalls ...................................................................................................................... 35
10 Returned Goods ...................................................................................................... 37
11 Handling of Non-conforming Materials ............................................................... 38
12 Dispatch and Transport ......................................................................................... 39
13 Contract activities ................................................................................................... 42
REFERENCES AND BIBLIOGRAPHY............................................................................. 44
Additional references ....................................................................................................... 44

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 I. Introductory Note
The International Pharmaceutical Excipients Council Europe (IPEC Europe) published the IPEC
Europe Good Distribution Practices Audit Guideline for Pharmaceutical Excipients in 2011 [1].
This guide was based on the assessment questionnaire SQAS ESAD Section F&G [11]. The
SQAS ESAD assessment system is widely used by European distributors to demonstrate their
quality, safety and environmental performance. Sections F&G of this assessment questionnaire
cover specifically GDP aspects for food, cosmetic and pharma ingredients. Not to just duplicate
this questionnaire, IPEC Europe aligned it’s IPEC Europe GDP Audit Guideline for Distributors of
Bulk Pharmaceutical Excipients 2011 [1] to Sections F&G of the SQAS ESAD questionnaire
ensuring its consistency with the IPEC GDP Guidelines for pharmaceutical excipients 2006. In
parallel, IPEC Americas developed a GDP audit guide in 2011 which was aligned to the IPEC
GDP guidelines for pharmaceutical excipients 2006 and to the specific needs in North America.
This document was developed as a consolidation of both aforementioned GDP audit guides. It
harmonises both guides and is a revision to align the guide with the IPEC GDP Guide for
Pharmaceutical Excipients revised in 2017 [3].
The purpose of the document is to assist the users in evaluating the practices and quality systems
of distributors who sell, store or repackage pharmaceutical excipients or any combination thereof.
For the purpose of this guideline “distributors” includes those parties involved in trade and
distribution, repackaging, relabelling, sampling, testing, retesting, transportation and warehousing
operations, as well as forwarding agents, brokers, traders, and suppliers other than the original
manufacturer.
For definition of technical terms, please refer to the current IPEC General Glossary of Terms and
Acronyms [6].
For auditing of manufacturing activities such as repackaging, reprocessing, blending, mixing,
milling, micronisation or any other physical manipulation of pharmaceutical excipients, please
refer also to the current IPEC-PQG Good Manufacturing Practices Guide for Pharmaceutical
Excipients [4] and the current IPEC GMP Audit Guide for Pharmaceutical Excipients [5].

II. Scope
This Questionnaire is linked to the IPEC GDP Guide for Pharmaceutical Excipients revised in
2017 [3] which is based on the WHO Good Trade and Distribution Practices for Pharmaceutical
Starting Materials [7], and therefore it follows the same structure.
It applies to all steps in the distribution/supply chain starting from the point at which an excipient
is transferred outside the control of the original manufacturer's material management system.
Some sections and/or sub-sections in this document may not apply to all involved parties.

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This document is intended to provide a framework for the auditor who must always decide to what
level of detail and focus the audit must follow. It can therefore be used either as a self-assessment
questionnaire to be completed by a distributor/supplier, or as an audit check-list.

III. Pharmaceutical Grade Excipients

Parties involved in the supply chain should be aware that an excipient can only be designated
pharmaceutical grade when it is in compliance with pharmacopeial specifications and/or
appropriate regulatory requirements (if existing for the specific excipient) and is manufactured,
repackaged, and handled in accordance with excipient GMP principles (e.g., IPEC PQG GMP [4],
WHO Excipient GMP [8], EXCiPACT GMP/GDP Standard [9] and/or NSF/IPEC/ANSI 363 GMP
[10]).
Upgrading any other grade, e.g., food, technical, or industrial grade material to pharmaceutical
grade quality based only on analytical results found in conformance with the requirements of a
pharmacopeial monograph, is not an acceptable practice.

IV. Acknowledgements
IPEC would like to acknowledge the World Health Organisation (WHO) for their extensive efforts
in developing the guidelines “Good Trade and Distribution Practices for Pharmaceutical Starting
Materials” [6] in the revised version of 2016, which is valued by the IPEC Federation as a
significant step forward in the development of tools for the improvement of safety and quality of
starting materials and finished pharmaceuticals.
This Guide was developed by representatives from International Pharmaceutical Excipients
Council (IPEC) member companies. IPEC is an industry association whose members consist of
excipient manufacturers, distributors, and users. The company representatives who worked on
this Guide are listed below:

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Core Revision Team
IPEC Europe – GDP Committee
Lars Albermann, Merck
Rodrigo Arias, DFE Pharma
Jan-Christian Boy, Biesterf eld Spezialchemie
Mathias Brenken, MB-QAR
Karsten Diehl, BASF
Hagen Hagemeier, Brenntag
Eckart Krämer, SE Tylose
Frank Milek, Aug. Hedinger
Mirko Pogutter, Janssen
Axel Sewing, Avantor/VWR International
Georg Strasser, Janssen
Antje Voss, Dow Chemical
Allan Whiston, QA Resolutions

Commentators, Reviewers
IPEC-Americas
Dale Carter, Evonik
Lisa Frame, Dupont
Luke Grocholl, Millipore Sigma
Aasif Hanf i, Sanof i
Charlotte McIlvaine, Univar Solutions
Lucien Sergile Jr., Eli Lilly and Co.
Erika Vergara, Dow Inc.
Joesph Zeleznik, IMCD

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IPEC GDP
Question Comments/Notes
Guide
1 Quality Management

1.1 • Which type of quality management system (QMS) has

been implemented?
• According to which standard has the QMS been
designed against? (e.g., ISO 9001, GDP/GMP by a
competent authority, EXCiPACT®, ANSI/NSF/IPEC 363,
safety standards or another recognized standard)?
• How is the QMS documented?
• How does it address the following elements?
o scope of the QMS
o organizational structure
o written procedures, processes and resources or
reference to them; and
o a description of the sequence and interaction
between the procedures and departmental functions
• Does the Quality Policy contain commitment and
adherence to GDP/GMP signed off by top management?

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IPEC GDP
Question Comments/Notes
Guide
1.2 • Which elements comprise the infrastructure of the QMS
taking into account the size, structure and complexity of
the distributor and its activities?
• Describe the principles and tools of Quality Risk
Management within the QMS enabling a systematic
process for the assessment, control, communication and
review of quality risks to the product?
• How is it demonstrated that there is an independent
quality unit (or designee), which is responsible for all
quality-related matters
• How are suppliers of pharmaceutical excipients and
services selected, approved, disqualified and re-
approved?
• How are deviations managed?
• How are changes controlled?
• Under what conditions are customers notified about
changes?
• How is traceability of the excipient and associated
documentation ensured throughout the supply chain?
• How are the principles and scope for validation and
qualification defined depending upon the operations to
be performed?

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IPEC GDP
Question Comments/Notes
Guide
1.3 • The system should cover for example, but not limited to
the quality assurance principles in the GDP Guide

1.4 • What is the evidence for shared responsibility assuring

that the excipient conforms to the mutually agreed
specification and is suitable for its intended use by the
pharmaceutical industry?
• How is it ensured that materials are purchased against
agreed specifications and only from approved suppliers?
• What proven evidence is in place to assure that the
distributor and the customer have mutually agreed upon
the specifications and other requirements?

1.5 • How is it ensured that there is an adequate number of

qualified personnel available to perform all operations in
compliance with this guide (refer to 2.2)?
• Who in the organisation is responsible to ensure
compliance with the applicable provisions of the GDP
guide?
• Demonstrate who is responsible for final batch release in
the QMS, if applicable?
• What controls are in place for the responsibilities of the
quality unit that have been delegated to other personnel
and/or contractors?
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IPEC GDP
Question Comments/Notes
Guide
1.5 • If contractors are used to perform responsibilities, how
have they been trained and qualified for this purpose?

1.6 • How is it ensured that E-Commerce procedures are

documented and comply with the requirements for
excipient quality and traceability according to GDP?

1.7 • How does the release procedure 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?
• What do you inspect on excipient provided only in
originally sealed containers from the manufacturer?
• How is the GMP status of the excipient verified and
documented?

1.8 • Which QRM principles are applied to demonstrate

compliance with GDP?
• How do those applied principles demonstrate
compliance with GDP?

1.9 • How does the organization manage the internal quality

audit program?
• How does the internal quality audit program direct
continuous improvement?
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IPEC GDP
Question Comments/Notes
Guide
1.9 • Which principles are applied to determine the internal
audit plan and schedule?
• How are internal audits documented and related
activities (e.g., investigations, corrective and preventive
actions) tracked?
• How are the responsible management personnel made
aware of the audit findings and the corrective and
preventive actions to be taken?
• How is it ensured that corrective and preventive actions
are completed and checked for effectiveness?

2 Organisation and Personnel

2.1 • How are adequate personnel resources provided in

terms of number and qualification to perform and
supervise the operations performed in compliance with
applicable GDP requirements?
• How is the organizational structure documented?
• How is independency of the quality unit or function from
operational functions ensured?

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IPEC GDP
Question Comments/Notes
Guide
2.1 • How is demonstrated that the quality unit is able to
perform the relevant tasks, e.g., handling of non-
conformities, documentation and traceability of the
excipient distribution activities?

2.2 • How are required qualifications assigned for GDP

related tasks?
• How are qualifications and training documented for each
employee?
• How is it demonstrated that the qualification and training
program for individual personnel is suitable for the
operations performed?
• How are levels of authorization and decision-making
workflow defined, communicated and documented?
• What information is contained in the list of providers of
GDP related services?

2.3 • How is it ensured that all relevant personnel are aware

of the principles of the appropriate guidelines, including
but not limited to GDP?

2.4 • Describe the system for planning, delivery, frequency

and follow up of initial and continuing training?

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IPEC GDP
Question Comments/Notes
Guide
2.4 • How is it ensured that trainers are appropriately qualified
for the trainings to be given?
• How are trainings documented?
• How is it ensured that trainings are conducted in
accordance with the training plans for all employees
including consultants and contractors?
• How is training effectiveness and employee competency
assessed?
• How are job-specific training requirements clearly
defined?
• How is it demonstrated that GDP principles are included
in training and qualification for all relevant personnel?

2.5 • What training is provided to personnel for safe

hazardous material handling (such as highly active,
toxic, infectious, flammable, sensitizing or corrosive
materials) including Personal Protective equipment
(PPE) requirements?
• What are the procedures in place to ensure appropriate
protection of the personnel from hazardous materials?
• How is it demonstrated that the necessary PPE is
provided for handling hazardous materials? How is this
communicated to employees?

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IPEC GDP
Question Comments/Notes
Guide
2.5 • How is it ensured that protection procedures are not in
conflict with the hygiene program or a risk assessment to
ensure the quality and the hygiene for the product is
maintained?

2.6 • What personnel hygiene requirements and PPE are

specified and how is it communicated to employees?
Ensure that requirements indicate cleanliness of apparel
and PPE.
• How are personnel informed of the requirement to report
any health conditions that may have an adverse effect
on the product?
• How are personnel with illness or open skin lesions
prevented from potential contaminate or otherwise
adversely affect the safety or quality of the product are
allowed to work in any operation that could cause the
product to become contaminated?
• What is the policy on loose and/or unsecured jewellery
or other items in operations where they can fall into the
product? How are personnel observed to be in
compliance?
• Where can personnel store and consume food,
beverage, tobacco products or personal medication?
How are these areas designated?

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IPEC GDP
Question Comments/Notes
Guide
3 Premises

3.1 • Describe how the space and environmental controls

ensure excipient integrity and avoid mix-ups or cross-
contamination during handling, packaging, testing and
storage operations.
• Describe how facilities and buildings appear. Are they in
a good state of repair?
• Describe how the preventive maintenance program
ensures the integrity of operations that are being
performed.
• Are the facilities clean appropriate to the operations
being performed?
• How is cleaning of the facilities facilitated?
• What risk assessment was performed concerning other
materials packaged or stored in close proximity to the
excipient where it is exposed to the environment?
• In case highly sensitizing, toxic or volatile products are
handled, how are they separated and are there risk
based controlled to avoid cross-contamination or mix-
ups? What evidence is there that these measures are
effective?

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IPEC GDP
Question Comments/Notes
Guide
3.1 • How is it demonstrated that there are adequate facilities
to perform sampling and testing of raw materials,
packaging components, intermediates and finished
excipients, if required?

3.2 • What measures have been taken to prevent

unauthorized access to the premises?
• What measures are in place to prevent unauthorized
access to packaging, warehouse and laboratory areas?

3.3 • What measures are taken to protect the excipient from

contamination due to insects, rodents, birds, and other
animals, especially in case premises and equipment are
located outside?
• What kind of pest control program is in place and how is
it managed?
• How is it controlled and how is its effectiveness
monitored?

3.4 • How is contamination, cross-contamination and

degradation of excipient avoided in supporting facilities,
such as air control, ventilation and lighting?

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IPEC GDP
Question Comments/Notes
Guide
3.4 • Are the utilities that could affect excipient quality
identified and how are they determined to be
appropriately monitored?
• What kind of risk assessment has been conducted to
determine the necessary controls for utilities (e.g.,
nitrogen, compressed air, steam, water) that could affect
excipient quality?

3.5 • If sampling is performed, which measures are in place to

avoid deterioration, contamination and cross-
contamination (e.g., separation, controls of
environment)?
• What cleaning procedures are in place for the sampling
area?

4 Procurement, warehousing and storage

4.1 • How are excipient specifications agreed?

4.2 • What procedures are in place to minimize the risk of

receiving or forwarding falsified and/or non-conforming
excipients?

4.3 • How is receipt, storage and distribution of excipients

performed and is this described in a written procedure?

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IPEC GDP
Question Comments/Notes
Guide
4.3 • How does the written procedure cover visual inspection
of the container (packaged or bulk) including its security
features (e. g. seals), confirmation of excipient identity
from the label against documentation and recording of
these data?
• What assurances are in place that all receipts are from
approved suppliers?
• What checks are performed prior to loading of excipients
and do they include a check for cleanliness of the
vehicle used?

4.4 • How is it ensured that the storage area has sufficient

capacity to ensure orderly storage, appropriate
segregation and correct selection of designated
excipients?
• How is segregated storage of different batches of
excipients and of excipients from other grade materials
ensured to avoid contamination and mix-ups?
• How is it ensured that containers are stored protected
from adverse environmental conditions, and stored in
compliance with safety requirements (e. g. in case of
dangerous goods)?
• Where are computerized system utilised to support
segregation during storage?

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Question Comments/Notes
Guide
4.4

4.5 • How are reception/ dispatch areas set up? Do they allow
for the cleaning of incoming containers if necessary?
• How are received excipients segregated until release?

4.6 • How are received, quarantined, rejected, recalled,

returned, non-conforming and commissioned excipients
segregated?
• How is it ensured that any quarantined, rejected,
recalled or otherwise blocked excipient cannot be
selected for production or distribution purposes?
• If no physical segregation is implemented, how is it
ensured, that the electronic system used for segregation
is properly and consistently working?
• How is access to blocked material controlled?

4.7 • In what condition is the storage area?

4.8 • How are segregated areas and excipients identified?

4.9 • How are any required storage and/or shipping conditions

controlled during possession of the excipient by the
auditee?

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IPEC GDP
Question Comments/Notes
Guide
4.10 • How are required storage conditions for excipients
applied, monitored and documented?
• What are the actions to be taken in case of deviations
from required conditions?

4.11 • How is it ensured that highly active materials, narcotics,

other dangerous drugs and substances presenting
special risks of abuse, fire or explosion are stored in a
safe, dedicated and secure areas apart from excipients?

4.12 • How is it ensured that equipment used for bulk handling

and storage is suitable for the excipient, regularly
cleaned and maintained?
• What additional controls for bulk excipients are used to
assure material purity, freedom from contamination and
mix-up (e.g., dedicated tankers/storage tanks,
certificates of cleaning and identification/restriction of
prior content)?

4.13 • How is packaging of excipients performed and does this

include appropriate protection of the excipient quality
and authenticity?
• In which way are excipient containers sealed to identify
any evidence of tampering?

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IPEC GDP
Question Comments/Notes
Guide
• Where special shipping conditions are required show
how they are defined, provided and controlled.

4.14 • What evidence is there that spills are to be cleaned up

promptly (equipment, procedures)?

4.15 • How are waste materials stored, identified and disposed

of?

4.16 • How is stock rotation managed in the warehouse

(e. g. EEFO, FIFO)?

4.17 • How is it ensured that excipients that reached their

expiry or retest date are withdrawn from saleable stock
unless the shelf life has been extended in case of retest
dates?

4.18 • How is stock inventory regularly checked for quantities

and expiry/retest dates and what is done in case of
discrepancies?

4.19 • What controls are in place to ensure that the correct

excipient is picked, packed and distributed with
appropriate remaining shelf life (if applicable) and are
these documented including batch numbers?

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Question Comments/Notes
Guide
4.20 • Describe how the sanitation program is documented?
• How is cleaning of the warehouse performed and
documented?
• How do you document findings following formal
inspections of the warehouse including for waste, vermin
and pest control?

5 Equipment

5.1 • How is equipment commissioned, designed, installed

and qualified prior to initial use?
• Is equipment maintained in a good state of repair?
• What material of construction is used to not adversely
affect the excipient?
• How is preventive maintenance and equipment cleaning
scheduled?
• What system is in place for cleaning, inspecting and
approving equipment for use after maintenance and
repairs have been performed and how is this process
documented and managed?
• How have the personnel been trained to perform and
record these activities?

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Question Comments/Notes
Guide
5.2 • How do you ensure that defective equipment is not
used?

5.3 • How is it ensured that the status of equipment can

readily be identified?

5.4 • What is the method to identify content (and direction of

flow if applicable) of pipework?

5.5 • How do you avoid mix-up of connections for services,

piping and devices? How are services, devices and
pipework identified?
• Describe provisions of non-interchangeable connections
or adaptors for dangerous gases, liquids and other
materials if applicable.

5.6 • Are balances and other measuring devices of suitable

range and precision?
• How is calibration of critical measuring devices ensured,
traceable to applicable standards, documented and
recorded?
• What actions does the calibration procedure describe to
be taken regarding measurements using a balance or
device that is subsequently found to have been beyond
the due date or out of calibration limits?
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Question Comments/Notes
Guide
5.6 • How is the current calibration status and range known to
users and is it readily available?

5.7 • If equipment is not dedicated, what controls are used to

prevent cross-contamination (e.g., cleaning)?
• How is the record of use of the equipment documented?
• What data shows that cleaning procedures are adequate
to remove the previous materials?
• How are hoses and additional connection parts
adequately stored to avoid contamination and damage,
when not in use?

5.8 • What measures are in place to prevent contamination in

case of open equipment, if used?

5.9 • Describe the procedures in place for the operation and

maintenance of equipment.
• How is it ensured that lubricants or other materials with
potential direct contact with the excipient are of
appropriate grade e.g., suitable in food applications?

5.10 • How do you ensure that washing and cleaning

equipment does not contaminate the excipient?

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Question Comments/Notes
Guide

6 Documentation

6.1 • What procedure describes the writing, handling and

updating of documents?
• Who is authorized to complete, approve, sign and date
documents?
• What is the procedure for making changes to
documents?
• How is version control managed?
• How are specifications for materials and packaging
handled including reviews, revisions and availability?

6.2 • Do documents contain a title and describe their nature

and purpose?
• Are documents written in a clear, easy to check format?
• How is the revision history of documents displayed?

6.3 • What kind of CoA is provided to the customer?

• How does the CoA allow traceability to the original
manufacturer and
organization issuing the CoA?

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Question Comments/Notes
Guide
6.3 • How are the results determined for each test reported on
the CoA? If skip lot testing is performed, how is it
indicated?
• If batch (lot) mixing is performed, does the distributor
test and issue its own CoA?

6.4 • How does the distributor verify the manufacturer’s CoA

and test results support conformance to the excipient
specification?
• How is it ensured that a CoA is made available for each
shipment to the customer?

6.5 • How is information about original manufacturer and

intermediaries handling the excipient being made
available to authorities and end-users?

6.6 • What are the criteria used to determine the need for
quality agreements?
• How do the quality agreements ensure, that
mechanisms are in place to allow transfer of information,
e.g., quality or regulatory information and change
control?

6.7 • Are labels applied by the distributor clear and

unambiguous?

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Question Comments/Notes
Guide
6.7 • How do you ensure that labels are permanently fixed to
containers?
• What material of construction makes labels indelible?

6.8 • Does the excipient label contain adequate information to

identify the contents, quantity, batch number,
manufacturer (where applicable), retest or expiry date
and name and contact details of the supplier?
• Is information on storage conditions and handling
precautions on the label?
• If labels are printed as needed, what system is used to
verify and document the accuracy of the label content?

6.9 • How are relevant storage and handling information as

well as safety data sheets made available?

6.10 • How is it ensured that all records relating to the

requirements of Good Distribution Practices are kept and
readily available?
• Does the record retention policy cover the required
record retention period of one year after expiry or re-
evaluation date or 5 years from date of manufacture?

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Question Comments/Notes
Guide

7 Repackaging and relabeling

7.1 • How are operations, such as combining into a

homogeneous batch, repackaging and/or relabeling
performed?
• Which quality management principles do you apply?

7.2 • How is the prevention of contamination, cross-

contamination and mix-ups managed and assured?
• What environmental conditions are required to be in
place and when repackaging is performed how is
contamination prevented during those operations?
• How is the risk assessment designed to minimize the
risk of contamination and cross contamination?
• How are personnel hygiene and any special hygiene
requirements ensured? How is training recorded?
• What protective clothing are operators to wear in the
packaging area?
• How are labels (including labels for relabeling) controlled
(see detailed questions in 7.12)?

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Question Comments/Notes
Guide
7.2 • How is ensured that there is traceability to the batch
number, manufacturing date and expiry date of the
original manufacturer?
• How is product integrity maintained throughout the
repackaging/relabeling process?
• How is the original product label controlled?
• How is each step for repackaging and relabeling
recorded?

7.3 • How is packaging material received, quarantined,

inspected and released or rejected?

7.4 • How is conformity of each batch confirmed prior to

blending into a homogeneous batch?
• How is it ensured that blending processes are performed
in conformance with IPEC PQG GMP Guidelines?
• How is homogeneity of blended batches ensured,
demonstrated, and documented?

7.5 • How is it ensured that only batches from the same

manufacturing site are mixed?
• How are mixed batches sampled, tested and released?
• How are CoAs for mixed batches generated?

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Question Comments/Notes
Guide
7.5 • Which data are provided on CoAs for mixed batches?

7.6 • How is traceability back to the original manufacturer and

manufacturing site documented and communicated to
the customer?

7.7 • How are expiry or retest dates defined for mixed

batches?

7.8 • What analytical data are provided on the CoAs?

• Which analytical methods are applied in case of re-
testing?

7.9 • How are quality and suitability of packaging materials

established?
• How are packaging materials approved?

7.10. • In cases where containers are re-used, how are

processes defined and risk evaluated?
• How are cleaning processes of re-usable containers
validated?

7.11 • How are the required environmental conditions ensured

during repackaging?

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7.12 • How is it ensured that all information is correct on the
labels?
• How are crosschecks made that the correct information
is contained on the labels?
• How is it ensured that the correct quantity of labels are
printed and issued?
• How and where are labels stored?
• What is the process to avoid mislabeling?
• How are labelling and label reconciliation processes
documented?
• What is the procedure and who is responsible to remove
and destroy any excess labels that are not required for
(re-) packaging?
• Where are copies/samples of labels kept for each batch?

7.13 • How is information about the original manufacturing site

provided to the customer?

7.14 • How is identity and quality of the excipient maintained

before and after repackaging?
• How is traceability of the excipient documented before
and after repackaging?

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Question Comments/Notes
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7.15 • How is it ensured, that each repackaged batch conforms
to the specification taking into account those properties
that might be affected by the repackaging?

7.16 • Describe the procedure to ensure that appropriate

repackaging documentation is evaluated together with
the test results prior to release of the repacked material.

7.17 • How is it ensured that sampling, analytical testing and

batch release procedures comply with GMP?

7.18 • Which analytical methods

o are pharmacopoeia methods?

o are alternative methods?
o are original manufacturer’s methods?

• How do you ensure that alternative methods are

validated?
• Show the validation results, if applicable.
• How are the methods identified on the CoA?
• How are test results of contract laboratory identified on
the CoA?

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7.18 • How is skip batch (lot) testing or reduced testing
identified on the CoA?
• How is it ensured the methods used are current and
valid?

7.19 • How are out-of-specification test results investigated and

documented?

7.20 • How long are retain samples kept?

• How is the retention period of retain samples justified?
• Which quantity of retain sample is kept?
• How are the storage conditions of the retain samples
justified?

7.21 • How is it ensured that stability and shelf life of

repackaged material is not adversely affected?
• How are stability studies of the excipient within the used
packaging material conducted?
• How are primary packaging materials and storage
conditions taken into account?
• How long is the shelf life (retest or expiry period)
compared to recommended shelf life provided by the
original manufacturer?

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Question Comments/Notes
Guide
7.21 • How are shelf lives justified which are different from the
manufacturer’s recommendation?
• How are special storage conditions indicated on the
label?

8 Complaints

8.1 • What is your procedure for handling of complaints?

• What are the actions to be taken and the criteria on
which recall decisions should be based?
• Who has responsibility for investigation of complaints?
• How and where are the complaint records retained?
• How are complaint records periodically reviewed for
trends, frequency, and criticality in order to identify
preventive actions and how is this documented?

• What is the investigation process?

8.1 • How do you determine root cause, definition of CAPAs,
and
and related documentation?
8.2
• How is the customer informed of investigatory findings?

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8.3 • Where complaints are justified, has consideration been
given whether the reported defect is limited to a single
batch? How is this documented?
• How are (potentially) impacted batches identified,
labelled and/or segregated and subsequently managed?

8.4 • Where a complaint is justified, how do you define follow-

up actions and evaluation of the complaint?

8.5 • Where a complaint is justified, how is the excipient

manufacturer as well as the customer notified?

9 Recalls

9.1 • What is your process for conducting a product recall

(retrieval) or market withdrawal? How does it cover the
following?

o managing the risk involved?

o defining responsibilities and functions to be involved?
Including approval

o communication and documentation?

o determining the steps needed to retrieve the

excipient?

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Question Comments/Notes
Guide
9.1 o ensuring that recalls (retrievals) are managed
promptly and effectively?

9.2 • How do you notify the excipient manufacturer about

recalls (retrievals)?

9.3 • How and when was the recall (retrieval) procedure last
verified?

9.4 • How is recalled excipient controlled to prevent its

inadvertent release while pending investigation and
disposition?

9.5 • In the event of serious or potentially life-threatening

situations: How is it ensured that all customers and
competent authorities are promptly notified of the
decision to recall the excipient in all countries that have
received the excipient?

9.6 • How are pertinent records made available to the person

responsible for the recall activities?

• How is it ensured that the records contain sufficient

information to facilitate the recall activities?

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Question Comments/Notes
Guide
9.7 • How is the effectiveness of the arrangements (procedure
and process) for recalls evaluated?
• At what frequency are mock recalls conducted?

10 Returned Goods

10.1 • How do you ensure identification, quarantine and

traceability of returned excipients?
• What information do records on returns contain?
• How are storage and transportation conditions when not
under control of the distributor taken into account when
evaluating the quality of returned excipient?
o Are they evaluated by the Quality Unit prior to
disposition?

• How are these processes documented?

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Question Comments/Notes
Guide
10.2 • Who is responsible for deciding about the disposition of
returned excipients?
• What is your procedure and what are the criteria to
decide upon the disposition of returned excipients?
• How does your process address the following risks?
o evidence of tampering

o inappropriate storage conditions

o remaining shelf-life period

o approval of the excipient disposition by an

unauthorized and/or unqualified person
o loss of information/traceability

11 Handling of Non-conforming Materials

11.1 • How do you ensure that non-conforming excipients are

not (re-) introduced into the market including those
provided to external organizations for destruction?
• What do records of non-conforming excipients contain?

11.2 • What is your investigation procedure for non-conforming

excipients?

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Question Comments/Notes
Guide
11.2 • How do you determine root cause, consideration of other
batches and materials that might be affected, definition
of CAPAs, measures to establish the effectiveness of the
actions taken and related documentation?

11.3 • How do you document the disposition of non-

conforming excipients including its downgrading?

11.4 • How do you ensure that non-conforming excipients are Note: Mixing is not stated in the GDP guide.
not blended with excipients that comply with their
specifications?

12 Dispatch and Transport

12.1 • How is it ensured that loading, unloading and transport

activities do not adversely affect excipient quality?
• What is the process for qualifying and approving
carriers?
• How are special transport conditions such as
temperature, humidity and/or absence to sunlight
exposure, or special equipment, if required by the
excipient characteristics, communicated, agreed
between supplier, carrier and customer, monitored,
controlled and recorded in transit?
• How are deviations from special conditions managed?
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Guide
12.2 • How is it ensured that information such as product
quality/grade, special transport/storage conditions, as
existing, and/or legal requirements are provided to
customers for each shipment?
• How is it ensured that special storage and/or
transportation conditions (if applicable) are referenced
on the container label?

12.3 • How is the ability of the carrier assessed and

documented to meet special transport conditions and/or
requirements for special transport equipment?

12.4 • How are the requirements for bulk vehicles and

equipment communicated and documented to the
carrier?
• How are specific conditions for cleaning of transport
equipment, handling, sealing, application of prior cargo
product restriction or acceptance policy, and/or
segregated cargoes been agreed and documented
between excipient supplier and carrier?
• How is the cleanliness of the vehicle assessed and
documented for bulk shipments?
• Which records are kept for cleaning activities?

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Question Comments/Notes
Guide
12.5 • If applicable describe the handling process for bulk
shipments.
• Is dedicated equipment used for bulk shipments? If not,
what precautions are taken to prevent contamination and
cross-contamination of the excipient?
• How is it ensured that the type of transport and auxiliary
equipment such as seals, fittings, hoses, pumps and
contact materials are compatible with the excipient
product?
• Describe the control process for changes to transport
equipment and supplies handled by the carrier?

12.6 • How is it ensured that packaging materials and

transportation containers are suitable to protect the
excipient during transport?

12.7 • How have cleaning procedures and schedules been

demonstrated and validated to adequately remove the
prior contents to an acceptable level?
• How are cleaning procedures and schedules agreed
between supplier and carrier, maintained and records of
previous cargoes provided by the carrier?
• How is the list of restricted or acceptable prior cargo in
the vehicle maintained?
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Question Comments/Notes
Guide
12.8 • How are shipments secured based on risk to prevent
unauthorized access to the excipient during transport?
• Describe which security aspects, such as appropriate
tamper-evident seals are applied for transport equipment
and packaging?

12.9 • For shipment, how is it ensured that applicable

requirements including local requirements for
transportation are fulfilled with regards to safety aspects
(e.g., explosion hazard, transport of dangerous goods,
and contamination of the environment and or product)?

13 Contract activities

13.1 • Which contracts or technical agreements are in place for

all activities delegated to contractors?
• How is contractor training organized and provided,
where appropriate?

13.2 • How has conformance to applicable GDP requirements

by contract service providers been assured?
• How are contractors approved, including facilities,
equipment and quality system?

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Question Comments/Notes
Guide
13.3 • How is it ensured that operations at contract providers
do not present a risk of contamination to the excipient?
• How is it ensured that traceability is maintained in
contracted operations?

13.4 • What evidence indicates that responsibilities for

conformance to GDP, including quality measures are
defined between contract giver and contract provider in a
written agreement (contract, technical, service/quality
agreement)?

13.5 • How is it ensured that the contract provider receives

approval from the contract giver for any activities
subcontracted especially those involving sampling,
analysis, repackaging, and relabelling?

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REFERENCES AND BIBLIOGRAPHY
1. IPEC Europe Good Distribution Practices Audit Guideline for Pharmaceutical Excipients;
The International Pharmaceutical Excipients Council Europe, 2011
2. IPEC-Americas Good Distribution Practices Audit Guide for North American Distribution
of Pharmaceutical Excipients; The International Pharmaceutical Excipients Council of the
Americas, 2011
3. The IPEC Good Distribution Practice Guide for Pharmaceutical Excipients; The
International Pharmaceutical Excipients Council Federation, 2017
4. The Joint IPEC-PQG Good Manufacturing Practices Guide for Pharmaceutical Excipients;
The International Pharmaceutical Excipients Council and Pharmaceutical Quality Group,
2017
5. IPEC Good Manufacturing Practices Audit Guideline for Pharmaceutical Excipients; The
International Pharmaceutical Excipients Council Federation, 2008
6. IPEC General Glossary of Terms and Acronyms; The International Pharmaceutical
Excipients Council Federation, 2021
7. Good Trade and Distribution Practices for Pharmaceutical Starting Materials; World Health
Organization, WHO Technical Report Series, No. 996, 2016
8. Good Manufacturing Practices: Supplementary Guidelines for the Manufacture of
Pharmaceutical Excipients; World Health Organization, WHO Technical Report Series,
No. 885, 1999
9. EXCiPACT® Good Manufacturing Practices (GMP) / Good Distribution Practices (GDP)
Standard; EXCiPACT® Certification Standard 2017
10. NSF/IPEC/ANSI 363 - 2019 Good Manufacturing Practices (GMP) for Pharmaceutical
Excipients for Pharmaceutical; NSF International Standard / International Pharmaceutical
Excipients Council / American National Standard Institute 2019
11. SQAS Distributor / ESAD for Chemical Distributors, Questionnaire and Guidelines; CEFIC
and FECC, March 2006, revised April 2011

Additional references
12. Guide to Good Storage Practices for Pharmaceuticals; World Health Organization, WHO
Technical Report Series, No. 908, 2003
13. Good Manufacturing Practice for Active Pharmaceutical Ingredients (ICH Q7);
International Conference on Harmonisation, 2000
14. Model Certificate of Analysis; World Health Organization, WHO Technical Report Series,
No. 902, 2002
15. The IPEC Certificate of Analysis Guide for Pharmaceutical Excipients; The International
Pharmaceutical Excipients Council Federation, 2013

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