The IPEC Europe Good Distribution Practices Audit Guideline: FOR Pharmaceutical Excipients

The
IPEC Europe
Good Distribution
Practices
Audit Guideline
FOR
PHARMACEUTICAL
EXCIPIENTS
2011
Copyright © 2011 The International Pharmaceutical Excipients Council - Europe

Copyright © 2006 The International Pharmaceutical Excipients Council and
Copyright © 2006 Pharmaceutical Quality Group
Page ii
IPEC Europe Good Distribution Practices Audit Guideline for
Pharmaceutical Excipients
This document has been written to provide a tool for those auditing companies involved in the supply
chain of pharmaceutical excipients.
This Audit Guideline should be used in conjunction with the IPEC Good Distribution Practices Guide.
The explanatory notes in this guideline are provided to help the auditor obtain the maximum benefit in
its application.
This document is a revised version of the IPEC Good Distribution Practice Audit Guideline for
Pharmaceutical Excipients 2008 [1].
Table of contents Page
I. Introductory Note 2
II. Scope 2
III. Pharmaceutical Grade Excipients 2
IV. Acknowledgements 3
1. Quality Management 4
2. Organisation and Personnel 6
3. Premises 8
4. Warehousing and Storage 10
5. Equipment 14
6. Documentation 17
7. Repackaging and re-labelling20
8. Complaints 25
9. Recalls 26
10. Returned Goods 26
11. Handling of non-conforming materials 27
12. Dispatch and Transport 27
13. Contract Activities 29
Appendix Bibliography 31

Page 1
I. Introductory Note
The International Pharmaceutical Excipients Council (IPEC) first published a GMP Audit Guideline for
Distributors of Bulk Pharmaceutical Excipients in 2000. This document was designed as a questionnaire
to assist 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,
(re)processors, (re)packagers, transport and warehousing companies, forwarding agents, brokers,
traders, and suppliers other than the original manufacturer.
It is recognised by IPEC Europe that other documents are available and widely applied throughout the
distribution industry. With this in mind and in order to maintain consistency, IPEC Europe has utilised
many aspects of the Safety and Quality Assessment Scheme - SQAS Distributor Questionnaire (ESAD
system, primarily Section F and Sub Section G) [2]. As this document was revised during 2011 [3],
IPEC Europe also adapted this audit guideline accordingly. Wherever possible, original ESAD 2011
questions have been used. However, there are occasions when the IPEC - Europe GDP Audit Guideline
has additional questions not referenced in the ESAD 2011 questionnaire.
Some editorial changes have been made, some redundant questions deleted and additional questions
inserted, which are highlighted in grey. Furthermore, this document is now a separate document of
IPEC Europe. IPEC Americas published its own GDP audit guide reflecting the needs of the industry in
North America [8].
For definition of technical terms, please refer to the Glossary in the IPEC Good Distribution Practices
Guide [4].
More information on the SQAS ESAD Distributor system may be found at the following address
www.sqas.org
For auditing of manufacturing activities such as blending, mixing, milling, micronisation or any other
physical manipulation of pharmaceutical excipients, please refer to the IPEC-PQG Good Manufacturing
Practices Guide for Pharmaceutical Excipients [5].
II. Scope
This Questionnaire is linked to the IPEC Good Distribution Practices Guide [4] (based on the WHO
Good Trade and Distribution Practices for Pharmaceutical Starting Materials [6]), 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.
This document is meant 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 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 pharmaceutical grade
when it is in compliance with pharmacopoeial specification and/or appropriate regulatory requirements
(if existing for the relevant excipient) and is manufactured, repackaged, and handled in accordance with
excipient GMPs (e.g. IPEC PQG GMP [5], WHO Excipient GMP [7]). Upgrading technical or
industrial grade material to pharmaceutical grade quality based only on analytical results found in
conformance with the requirements of a pharmacopoeial monograph is an unacceptable practice.
Page 2
IV. Acknowledgements
The GDP Committee of the International Pharmaceutical Excipients Council – Europe (IPEC - Europe)
prepared this document.
IPEC Europe, the International Pharmaceutical Excipients Council Europe, is an association that serves
the interests of producers, distributors and users of pharmaceutical excipients. Together with its sister
associations, IPEC Americas and IPEC Japan (JPEC), the Council is a member of IPEC Federation
whose global membership extends to more than 200 companies.
IPEC Europe represents the views of its members to appropriate regulatory bodies (European
Commission, EMA, European Pharmacopoeia) and is recognised by Government agencies around the
world as the voice of European producers and users of pharmaceutical excipients. Combined advocacy
is essential to ensure introduction to the market of safe new excipients which meet globally accepted
standards.
Activities within IPEC Europe are organised through Committees or Working Parties, the activities of
which are communicated during the Annual General Meeting and in IPEC Europe newsletter, which are
regularly posted on the website (www.ipec-europe.org).
IPEC greatly appreciates the many hours of hard work by the following individuals devoted to
developing this Audit Questionnaire and the generous support provided by their employers:
IPEC-EUROPE
Dr. Mathias Brenken Dow Deutschland Anlagengesellschaft mbH
Michael Cooke Univar Europe
Christiane Dzala Bayer Pharma AG
Dr. Steven Hewitt Sanofi
Andrea Ivens Brenntag GmbH
Dr. Andreas Lekebusch Biesterfeld Spezialchemie GmbH
Dr. Frank Milek Aug. Hedinger GmbH & Co. KG – GDP Committee Chairman
Dr. Axel Sewing VWR International AG
Allan Whiston QA Resolutions Ltd.

Page 3
Refer to
Refer to
SQAS
Question IPEC GDP
Question Distributor Notes
Number Guide
ESAD 2011
section
section
1. Quality Management
Is there a quality management system 1.1

Q 1.1 implemented (Covered by an ISO 9001:2000 1.2 G1.1
certification)? 1.3
Are the GTDP*/HACCP** principles part of

the quality system?
Q 1.2 1.2 F1.1.1
* Good Trade and Distribution Practices
** Hazard Analysis and Critical Control Point
Is there a quality manual and written

procedures describing all GTDP related
Q 1.3 processes? 1.2
Is there a third party certification of the

quality system (Covered by ISO 9001:2000
Q 1.4 1.8 G1.2
certification or third party HACCP
verification)?
Is there a library of relevant regulations on

Q 1.5 1.1 G1.3
excipients for pharmaceuticals?
Is a person designated or a source defined to

keep the company informed about legislative
Q 1.6 1.1 G1.4
developments in the area of starting materials
for pharmaceuticals?
Are responsibilities for assessing the impact

of such legislative developments and for
Q 1.7 1.1 G1.5
proposing actions to comply with these
clearly defined?

Page 4
Question Refer to Refer to
Question Notes
Number IPEC GDP SQAS
Guide Distributor
Is a regular review made of the system for
Q 1.8 1.1 G1.6
compliance with legal requirements?
Does the company have a written policy

Q 1.9 including management's active commitment 1.1 G1.7
to Quality?
Q 1.10 Is the policy signed by top management? 1.1 G1.8
Does the company operate a documented

Q 1.11 11.1 G1.9
system for quarantining suspect product?
Is there a procedure for internal audits of the

Q 1.12 1.9 G1.10
management system including an audit plan?
Do those carrying out auditing have training

Q 1.13 2.2 G1.11
in auditing and evaluation techniques?
Is a formal management review of the

Q 1.14 Quality Management System held at least 1.9 G1.12
once a year?
Do management reviews consider:
- findings of internal audits,

Q 1.15 recommendations made and corrective 1.9 G1.13a
actions taken?
- the overall effectiveness of the system in

Q 1.16 achieving quality objectives? 1.2 G1.13b
- opportunities for updating and/or

Q 1.17 improving the system? 1.9 G1.13c
Do management reviews consider trends in

Q 1.18 customer complaints? 1.2 G1.14

Page 5
Question Notes
Guide Distributor
Do management reviews consider trends in
Q 1.19 1.2 G1.15
supplier related non-conformance claims?
Does the distributor demonstrate his

responsibilities to assure compliance with
Q 1.20 Product Stewardship principles along the 1.4 F7.1
entire supply chain?
Is there an adequate number personnel

available either in-house or contracted out to
Q 1.21 carry out all the operations in compliance 1.5 F1.2.5
with the IPEC GDP Guide?
Are there authorized release procedures in

Q 1.22 1.7
place?
Is there a copy of the manufacturers’

Q 1.23 documents (such as COA or COC) supplied 1.7
with each delivery?
2. Organisation and Personnel
Has the company a sufficient number of

Q 2.1 2.1 F1.2.1
qualified employees for these operations?
Have all (including administrative) personnel,

involved in handling and distributing Food,
Q 2.2 2.2 F1.2.2
Cosmetic or/and Pharma grade products been
made aware of the risks for human health?
Have all (including administrative) personnel,

involved in handling and distributing Food,
Q 2.3 Cosmetic or/and Pharma grade products been 2.4 F1.2.3
formally qualified according to written
criteria?
Q 2.4
Is there a person with the specific 2.1 F1.2.4
responsibility and the appropriate authority to
Page 6
Question Notes
Guide Distributor
deal with excipient related quality issues
within the company?
Are employees qualified according to GDP

Q 2.5 2.3 F1.2.6
principles?
Is there a specific qualification required for

employees responsible for key activities in
Q 2.6 2.5 F1.2.7
Health, Safety, Environment (HSE) and
Quality?
Are the HSE responsible persons providing

Q 2.7 regular training to employees dealing with 2.5
hazardous materials?
Have job descriptions been made and

Q 2.8 2.2 G2.1
regularly updated?
Has an evaluation been made of all activities 2.1

Q 2.9 G2.2
to identify training needs? 2.2
Are personnel qualified for GTDP relevant

Q 2.10 operations with specific (technical) 2.2 G2.3
background/education?
Q 2.11 Is initial and ongoing training provided? 2.4
Q 2.12 Are GTDP principles part of regular training? 2.3 G2.4
Are employee training and qualification

Q 2.13 2.4 G2.5
records maintained?
Are internal and external training courses

documented?
Q 2.14 2.4 G2.6
(Documentation of training should include
records of training effectiveness.)

Page 7
Question Notes
Guide Distributor
Are contracted service providers included in
Q 2.15 2.2
the training program?
Are contractors provided with information 2.2

Q 2.16 relevant to the job to be done? 2.3 G13.7a
13
Are contractors provided with appropriate 2.2
Q 2.17 training if necessary? 2.3 G13.7b
13
Are contractors provided with appropriate
Q 2.18 2.5 G13.7c
personal protective equipment?
Are there procedures in place ensuring good

hygiene of the personnel where exposure to
material in open containers may occur (e.g.
Q 2.19 2.6 G2.7
monitoring of health conditions, wearing of
protective clothes, respecting food/drink
policy, etc.)?
3. Premises
Are areas where pharmaceutical starting

materials are handled designed and operated
Q 3.1 in a way to ensure cleanliness, appropriate 3.1 G3.1
hygiene and a minimisation of cross-
contamination risks?
Are premises well constructed and in visibly

Q 3.2 3.1 G3.2
good condition?
Are appropriate laboratory facilities

Q 3.3 3.1 F1.5.4
available?
Has the site implemented security measures G3.3

Q 3.4 3.2
to control access of unauthorized persons? S1.1.1

Page 8
Question Notes
Guide Distributor
Are the premises designed, operated, and
Q 3.5 maintained to avoid infestation by rodents, 3.3
birds, insects, and other vermin?
Is there an effective pest control program in

Q 3.6 3.3 G3.4
place?
Q 3.7 Is the warehouse well ventilated? 3.4 G4.7
If a heating/air-conditioning system is
Q 3.8 installed is it compatible with the stored 3.4 G4.8
products?
Q 3.9 Is there adequate lighting in the warehouse? 3.4 G4.10
Is the design and operation of the air handling

Q 3.10 system appropriate to avoid contamination 3.4
and degradation of products?
Are the design, operation and maintenance of

gas utility systems (e.g. nitrogen or
Q 3.11 3.4
compressed air) appropriate to avoid
contamination of products?
If sampling is performed, are sampling areas

Q 3.12 arranged and procedures in place to prevent 3.5 G3.5
contamination and cross-contamination?
Is there a separate sampling area in a

Q 3.13 3.5
controlled environment?
Are cleaning procedures in place for

Q 3.14 3.5
sampling areas?
Are all samples taken and retained according

Q 3.15 3.5 F1.6.1
to written procedures?
Q 3.16
Are sampling procedures sufficient to ensure 3.5 F1.6.2

Page 9
Question Notes
Guide Distributor
representative samples for quality control?
Are utensils and sampling devices cleaned

Q 3.17 and stored in a manner to prevent 3.5 F1.6.3
contamination?
Do sampling processes ensure sufficient

Q 3.18 3.5 F1.6.4
protection of product quality?
Is it ensured that sampling installation is able

Q 3.19 3.5 F2.1.9
to provide a representative sample?
4. Warehousing and Storage
Are all product receipts performed according

Q 4.1 to written procedures?
4.1 F1.4.1
Is product reception recorded/documented

Q 4.2 according to a written procedure?
4.1 F1.4.3
Are there appropriate intake control

Q 4.3 procedures in place with conformity 4.1 F1.4.2
inspection, including the seals?
Are there appropriate written procedures for

Q 4.4 4.1 F2.1.8
cleaning and maintenance of tanks/silos?
Are there written procedures and 4.1

Q 4.5 F3.1.1
documentation for loading of products? 12
Are there written procedures and

Q 4.6 4.1 F3.1.2
documentation for unloading of products?
Are there written procedures to prevent

Q 4.7 contamination in the case that a container has 4.1 F6.1.5
to be opened?

Page 10
Question Notes
Guide Distributor
In the case that a container has to be opened,
Q 4.8 is there a quality re-certification and release 4.1 F6.1.6
procedure?
Is there a procedure for re-sealing containers

Q 4.9 after opening?
4.1 F6.1.7
Are there written procedures for storage and

Q 4.10 warehousing of products?
4.1
Does the procedure for storage of packaged

Q 4.11 products consider the risk of incompatibilities 4.1 G4.11
between products?
Is the product received in bulk checked

Q 4.12 and/or tested for quality and identification at 4.1 F1.5.1.
the receiving site?
Is each product lot released and re-certified

Q 4.13 each time it is mixed with another lot?
4.1 F1.5.3
Are materials stored in compliance with

Q 4.14 safety requirements?
4.2
Are containers stored in dedicated areas with

Q 4.15 adequate separation from other products in 4.2 F6.1.1
order to prevent errors?
Are the racking systems in good condition

Q 4.16 4.2 G4.9
and protected from vehicle collision?
Are containers of sensitive products stored

Q 4.17 under appropriate storage conditions that are 4.7 F6.1.4
adequately monitored?
Are containers stored protected from adverse

Q 4.18 weather conditions?
4.3 F6.1.3

Page 11
Question Notes
Guide Distributor
Are receipt and dispatch bays equipped with
Q 4.19 4.3 G4.1
means to protect materials from weather?
Are rejected and recalled materials stored in a

Q 4.20 4.4 G4.2
defined segregated area?
Are materials in segregated areas controlled

Q 4.21 with appropriate systems (e.g. physical or 4.5
computerized)?
Are segregated materials appropriately

Q 4.22 labelled?
4.5 G4.3
Are specific storage conditions maintained, 4.6

Q 4.23 monitored and controlled where necessary? 4.7
G4.4
Are storage requirements for dangerous

Q 4.24 goods met on site and during transportation?
4.8
Is there a system in place to ensure that

Q 4.25 equipment for bulk storage is designed 4.9 F2.1.1
according to product requirements?
Is the storage tank equipped with a monitored

nitrogen blanketing system or a drying
Q 4.26 equipment, if necessary, to protect the
4.9 F2.1.5
product against oxidation and / or moisture?
Is the quality of the blanketing gas, if used,

Q 4.27 4.9 F2.1.6
compatible with the product?
Is it ensured that the storage temperature is

always kept within a defined range and
Q 4.28 controlled, if necessary for product quality or
4.9 F2.1.7
stability?
Q 4.29 Is adequate spill clean-up equipment 4.10 G4.5
available and are procedures in place for

Page 12
Question Notes
Guide Distributor
containing/collecting any spillage?
Q 4.30 Can spills be adequately contained? 4.10 G4.6
Are waste materials awaiting disposal stored

Q 4.31 4.11
safely and properly?
Does the company apply FIFO (First In First

Q 4.32 Out) or EEFO (Earliest Expiry First Out) 4.12
principles in the warehouse?
Are containers stored subject to a shelf life

Q 4.33 control system?
4.12 F6.1.2
Is there a separate storage area provided for

pharmaceutical starting materials?
Q 4.34 (Acceptable practice is to store 4.13 G4.12

pharmaceutical starting materials together
with other raw materials used for cosmetic,
food and feed applications.)
Q 4.35 Is there a written cleaning program in place? 4.13
Are there records for cleaning activities

Q 4.36 4.13
available?
5. Equipment
Is there a documented approach for the

design and modification of equipment for the
5.1
Q 5.1 handling of pharmaceutical starting materials
5.2
including location, operation and
maintenance of equipment?
Q 5.2
Is each piece of equipment in contact with the 5.1 F1.7.3
product made of suitable materials (e.g. not 5.2
reactive, additive, or absorptive and will not

Page 13
Question Notes
Guide Distributor
adversely affect the product)?
Is the entire equipment in contact with

Q 5.3 products drained and capped after the 5.1 F3.2.5
operation, according to written procedures?
Is each piece of equipment (specifically

auxiliary equipment) designed and used in a
manner that minimizes the potential for 5.1
Q 5.4 contamination of the product with lubricants, 5.2 F1.7.5
coolants, metal fragments, or other 5.6
extraneous materials e.g. from pressurised
air?
Is defective equipment taken out of service,

Q 5.5 (e.g. either removed, disposed of or status 5.1
labelled)?
Is the entire equipment in contact with 5.1

Q 5.6 F3.2.1
products located in clean areas? 5.2
Are there procedures in place to ensure

Q 5.7 compatibility of equipment with the 5.2 F5.1.3
products?
Is pipe work (including devices) in contact

with product labelled with direction of flow, 5.3 G5.1
Q 5.8
where applicable (including name of 5.4 F1.7.2
material)?
Is the entire equipment in contact with F3.2.4

Q 5.9 5.4 F5.1.2
products clearly labelled?
Are there a sufficient number of balances and

Q 5.10 measuring devices available which are 5.5 G5.2
necessary for the operation carried out?

Page 14
Question Notes
Guide Distributor
Is there evidence (records) of regular
Q 5.11 5.5 G5.3
(quality-critical) equipment calibration?
Is there a process in place to consider if

deviations of calibration of quality critical
Q 5.12 equipment have had an impact on the quality 5.5
of product since the last successful
calibration?
Do operation procedures detail how each

Q 5.13 piece of equipment critical to the processes 5.6 G5.4
should be used?
Is the maintenance policy covered by written

Q 5.14 5.6 G5.5
procedures?
Q 5.15 Is there a Preventative Maintenance Plan? 5.6 G5.6
Q 5.16 Are maintenance records available? 5.6 G5.7
Is there a process in place for monitoring and

Q 5.17 5.6 G5.8
approving the quality of maintenance?
Is each piece of equipment in contact with the

5.6
Q 5.18 product cleaned and maintained according to F1.7.4
5.8
written procedures?
If product exposure to, or contamination

with, lubricants or coolants is possible, are
Q 5.19 5.6
these materials suitable for use in food
applications?
Is appropriate cleaning equipment selected to

Q 5.20 5.7 G5.9
avoid contamination of products?
Q 5.21
Is each piece of equipment in contact with the 5.8 F1.7.1
product dedicated to the product or
effectively cleaned according to a written

Page 15
Question Notes
Guide Distributor
procedure?
Are all pieces of equipment coming in

contact with the product, compatible with the
Q 5.22 5.8 F2.1.2
product and in compliance with legal
requirements?
(If equipment is not dedicated) is the

Q 5.23 equipment only used for Food, Cosmetic, 5.8 F2.1.3
and/or Pharma grade products?
Is there an effective cleaning procedure in

Q 5.24 5.8 F2.1.4
place, whenever product change is necessary?
Q 5.25 Is controlled testing equipment available? 5.5 F1.5.4
Is all the equipment in contact with products

dedicated or are validated cleaning F3.2.2
Q 5.26 5.8
procedures applied in case of product F3.2.3
changes? F5.1.1
Is cleaning efficiency of non-dedicated

Q 5.27 5.8
equipment verified?
6. Documentation
Is there a document control system in place

ensuring proper design, approval, review, and 1.2
distribution of necessary documentation? 6.1
Q 6.1 G6.1
6.2
(Covered in the case of ISO 9001:2000 6.10
certification)
Is there evidence that documents are laid out

Q 6.2 in an orderly manner and with clear and 6.2 G6.2
unambiguous content?
Q 6.3
Is every product lot accompanied by a 6.3 F1.4.4

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Question Notes
Guide Distributor
certificate of analysis (COA) or certificate of
conformity (COC)?
Do COAs clearly indicate which tests are F1.4.5

Q 6.4 performed on every lot and which results are 6.3
obtained by skip lot testing?
Does this certificate provide information

Q 6.5 6.3 F1.4.6
about the origin of the product?
Are COAs from original manufacturers 1.7

Q 6.6 checked against agreed specifications? 6.4
G6.3
Is regulatory and quality information from

Q 6.7 6.6 G6.4
the manufacturer transferred to customers?
Is the company able to provide full 6.5

Q 6.8 F1.3.1
traceability on product origin? 7.11

Q 6.9 F1.3.2
traceability in its own operations? 7.11

Q 6.10 F1.3.3
traceability on product destinations? 7.11
Are distribution records kept for each

Q 6.11 6.5 F4.1.9
shipment?
Are loading/shipment data documented so

Q 6.12 6.5 F6.2.2
that details can easily be traced back?
When new updated information becomes

Q 6.13 6.6 G6.9
available, is it dispatched in a timely manner?
Is it ensured that no upgrading of industrial or

See III in
technical grade products with identical names
Q 6.14 the F1.4.9
to food, cosmetic and/or pharma grade
Guideline
products can occur?

Page 17
Question Notes
Guide Distributor
Are labels applied to containers clear, 6.7
Q 6.15 G6.5
unambiguous, and permanently fixed? 1.7
Is it ensured that the following information is

provided with each shipment, either on the
label or on the COA:
- the name of product, including grade and

Q 6.16 6.8 G6.6a
amount?
- the batch number assigned by the original

manufacturer or the batch number assigned
Q 6.17 6.8 G6.6b
by the re-packer, if the material has been
repacked and re-labelled?
- the retest date or expiry date and storage

Q 6.18 6.8 G6.6c
conditions (where applicable)?
- identification of the original manufacturing

Q 6.19 6.8 G6.6d
site and contact details of the supplier?
Is the expiry date, re-test date or the shelf-life

Q 6.20 written on each container (drums, IBCs, bags, 6.8 F5.2.6
etc)?
Is a Safety Data Sheet (SDS) provided in the

local language:
- with each sample of a commercialised

Q 6.21 6.9 G6.7a
product?
Q 6.22 - with a first order in a timely manner? 6.9 G6.7b
Are details recorded of the SDS dispatch

Q 6.23 6.9 G6.8
showing addressee and date?
Q 6.24
Are records and documents for every 6.10 F1.4.7
delivered batch retained for a defined period

Page 18
Question Notes
Guide Distributor
of time?
Is it ensured that COAs of the original

Q 6.25 manufacturer are only used for originally 6.5 F1.4.8
sealed and properly stored products?
7. Repackaging and re-labelling
Are there written procedures in place for each

Q 7.1 7.1 F5.4.1
processing operation?
Are batches of processed products

Q 7.2 7.1 F5.4.2
sufficiently tested for quality and released?
If hazardous (e.g. toxic, corrosive) products

are present on the site, is there a written
procedure for segregation or prevention of
Q 7.3 cross contamination? 7.2 F5.1.9
(The scope of this question includes highly

active material, e.g. cytotoxics, antibiotics.)
Is the environment of the re-packaging

Q 7.4 operation separated from other operations (or 7.2 F5.1.6
at least devoted to compatible products)?
Are there written procedures in place for all

Q 7.5 7.2 F5.2.3
packaging and labelling operations?
Are line clearance checks and label controls

Q 7.6 7.2 G7.1
carried out to avoid mislabelling?
Are there appropriate hygiene procedures in

Q 7.7 place for repackaging operations and 7.2 G7.2
repackaging personnel?
Q 7.8
Are written procedures in place to ensure 7.2 F2.2.1
batch homogeneity in case of mixing

Page 19
Question Notes
Guide Distributor
different batches in tanks/silos?
Is a sample for retention taken before

Q 7.9 7.2 F3.2.14
unloading?
Can liquid product be filtered prior to the re-

Q 7.10 7.2 F5.1.4
packaging operation when required?
Is there always a representative sample taken

Q 7.11 7.2 F2.2.2
after batch mixing?
Is there always a new batch number assigned

Q 7.12 7.2 F2.2.3
in case of batch mixing?
Is it ensured that analytical data on COAs for

Q 7.13 mixed batches are always based on new 7.2 F2.2.4
analyses?
Is each packed lot fully traceable (including

Q 7.14 7.2 F5.2.1
the packaging material)?
Are there packaging and labelling records

Q 7.15 available for each packaging and/or labelling 7.2 F5.2.4
operation?
Are samples of each batch of labels kept with

Q 7.16 7.2 G7.3
the packaging/labelling records?
Is mixing of lots from different 6.3

Q 7.17 G7.5
manufacturers avoided? 7.2
Q 7.18 Is each lot homogeneous in quality? 7.3 F5.2.2
Is there a system in place to prevent mixing

Q 7.19 of lots that do not conform to the 7.3 G7.6
specification with conforming lots?
Q 7.20
Are key point analyses performed for positive 7.3 F3.2.13

Page 20
Question Notes
Guide Distributor
identification and detection of evident
contamination before unloading?
Is the product checked and/or tested for

Q 7.21 quality and identification each time it is 7.3 F1.5.2
transferred from one container to another?
Are there key point controls performed prior

Q 7.22 7.3 F5.2.7
to each packaging process?
Is it clearly indicated on COAs issued by the

distributor on the basis of own analyses,
Q 7.23 7.4 F2.2.5
which items are performed on the specific lot
and which are created via skip lot testing?
Is it clearly indicated on COAs issued by the

distributor on the basis of own analyses, who
Q 7.24 7.4 F2.2.6
performed the analyses and who released the
product?
Is the customer informed when mixed lots are

Q 7.25 7.4 G7.4
supplied?
Are the methods used for the analysis clearly

Q 7.26 indicated on the COAs issued by the 7.5
distributor?
Prior to filling, is quality and cleanliness of

Q 7.27 7.6 F5.3.1
containers controlled?
Is there a written report for each cleanliness

Q 7.28 7.6 F5.3.2
inspection?
Is there a system to guarantee compatibility

Q 7.29 7.6 F5.3.3
between product and packaging material?
Is packaging material compatible with the

Q 7.30 7.6 F5.3.4
product shelf-life?

Page 21
Question Notes
Guide Distributor
Are container suppliers selected according to
Q 7.31 7.6 F5.3.5
quality criteria?
Are container suppliers qualified and

Q 7.32 7.6 F5.3.6
periodically assessed?
Are container suppliers informed about the

Q 7.33 7.6 F5.3.7
sensitive usage of the product?
Is there an agreement about the primary

Q 7.34 packaging materials used with the original 7.6 G7.7
manufacturers?
Are there written procedures on product shelf

Q 7.35 7.6 F1.3.4
life control?
Are stability studies carried out in case

products are repackaged into container
7.6
Q 7.36 different from the containers used by the G7.13
7.15
original manufacturer when this may be
critical to product stability?
Are the use of reconditioned containers and

Q 7.37 the re-use of primary packaging materials 7.7 F5.3.8
prohibited?
In the event of reuse of primary packaging

Q 7.38 material, is a validated cleaning procedure 7.7 G7.8
followed and previous labelling removed?
Is the environment of the re-packaging

Q 7.39 7.8 F5.1.7
operation clean and dust free?
Is the environment of the packaging

Q 7.40 operation pressurised with filtered air if 7.8 F5.1.8
necessary for the products?
Q 7.41
Is the re-labelling process consistent with 7.9 Di4.7.1

Page 22
Question Notes
Guide Distributor
legal requirements and industry standards?
Is there a review prior to use, of label

Di4.7.2
Q 7.42 contents against information from product 7.9
G7.7
suppliers?
Is the name of the original manufacturer

Q 7.43 7.10
mentioned on product labels?
Are written testing procedures in place for all

Q 7.44 7.12 F1.5.5
tests carried out?
Are all test data recorded and archived in a

Q 7.45 7.12 F1.5.6
traceable way?
Are repackaged batches released by the

Q 7.46 quality unit or function, independent from 7.12 G7.10
operations?
Are repackaging and quality records

Q 7.47 7.12 G7.11
reviewed prior to batch release?
Are only official pharmacopoeia methods or

Q 7.48 7.13 G7.12
validated analytical test methods used?
Is each packed lot linked to a retained

Q 7.49 7.14 F5.2.5
sample?
Are retained samples of sufficient size kept

Q 7.50 for each lot or shipment of repackaged or 7.14 F1.6.5
bulk products for a defined period?
Are retained samples stored for at least one

Q 7.51 7.14
year after expiry date?

Page 23
Question Notes
Guide Distributor
8. Complaints
Does the company operate a complaint

Q 8.1 8.1
procedure that describes actions to be taken?
Does the complaint procedure contain recall

Q 8.2 8.1 G8.1
criteria?
Are complaints recorded and investigated to 8.2

Q 8.3 G8.2
identify the origin and reason? 8.4
Are other batches considered during an

Q 8.4 8.3 G8.3
investigation of a complaint?
Are appropriate follow-up actions including a

Q 8.5 8.4 G8.4
possible recall taken?
Is there a procedure ensuring the original

manufacturer and customers are informed in 8.5
Q 8.6 G8.5
case of serious quality problems including 9.2
recalls?
9. Recalls
Is there a written procedure for product recall

Q 9.1 9.1 F1.3.6
in case of a quality concern?
Is the recall procedure regularly reviewed and

Q 9.2 updated?
9.3 G9.1
Is there a procedure ensuring all customers

and authorities are informed in case of
Q 9.3 serious or potentially life-threatening
9.5 G9.2
situations?

Page 24
Question Notes
Guide Distributor
Do records contain sufficient information to
Q 9.4 allow a recall?
9.6
Are records readily available to the

Q 9.5 9.6
designated person responsible for recalls?
Is the effectiveness of the recall system

Q 9.6 9.7 G9.3
evaluated?
10. Returned Goods
Are returned products stored separately and 10.1

Q 10.1 appropriately handled according to written 4.4 F6.3.1
procedures? 9.4
Is there a system in place to ensure that

Q 10.2 returned goods are placed in quarantine?
10.1 G10.1
Is there a procedure defining the process of

Q 10.3 deciding about the fate of returned goods?
10.1 G10.2
11. Handling of non-conforming materials
Are there written procedures on how to

Q 11.1 handle non-conforming, returned and rejected 11.0 F1.3.5
lots?
Is there a procedure ensuring that non-

conforming materials are prevented from
Q 11.2 reintroduction into market unless
11.1 G11.1
downgraded or reprocessed?
Are activities with non-conforming products

11.1
Q 11.3 documented (including downgrading and
11.3
G11.3
disposition)?

Page 25
Question Notes
Guide Distributor
Are product non-conformances investigated
Q 11.4 including consideration of other batches?
11.2 G11.2
Is feedback from customers entered into the

Q 11.5 non-conformance system?
11.2 G11.4
Is there a procedure in place to prevent

Q 11.6 blending of non-conforming materials with 11.4 G11.5
compliant materials?
12. Dispatch and Transport
Are there procedures in place to ensure

Q 12.1 controlled conditions during transportation of 12.1 G12.1
products where necessary?
For container loading/shipment is there a

Q 12.2 12.1 F6.2.1
check list for final inspection?
Are special transport conditions stated on the

Q 12.3 12.2 G12.2
label where necessary?
Is there an evaluation of transporters in

Q 12.4 12.3 F4.1.1
accordance to SQAS or similar schemes?
Is a key point analysis performed for positive

Q 12.5 identification and detection of evidence of 12.3 F3.2.10
contamination after loading?
Are there formal agreements in place with

12.3
Q 12.6 transport contractors, specifying sealing F4.1.7
12.8
requirements?
Is the integrity of seals checked before

Q 12.7 12.4 F3.2.12
unloading?

Page 26
Question Notes
Guide Distributor
Is dedicated transport equipment exclusively 12.4
Q 12.8 F4.1.3
used? 12.5
If non-dedicated equipment is used, are there

Q 12.9 any specific cleaning procedures with a 12.4 F4.1.4
cleaning certificate imposed?
Are cleaning procedures validated? 12.4

Q 12.10 F4.1.5
12.7
If non-dedicated equipment is used, is there a

12.4
Q 12.11 list imposed of prohibited or allowed last F4.1.6
12.7
cargoes?
Is there an inspection made of the transport

Q 12.12 12.4 F3.2.7
equipment cleanliness before loading?
Is inspection cleanliness documentation

Q 12.13 12.4 F3.2.8
available?
Are loading and unloading operations

Q 12.14 12.4 F3.2.6
designed to avoid contamination of products?
Is there a formal agreement with transport

Q 12.15 companies, specifying suitable materials in 12.5 F4.1.8
contact with the products?
Is a retained sample from the filled transport

Q 12.16 12.5 F3.2.9
equipment taken after loading?
Are packaging materials used which prevent

Q 12.17 12.6 G12.3
damage to the materials?
Is it ensured that bulk transport equipment

Q 12.18 and containers received and delivered are 12.8 F1.4.10
properly sealed?
Q 12.19
Are all valves and openings sealed after 12.8 F3.2.11

Page 27
Question Notes
Guide Distributor
loading?
Q 12.20 Are transport regulations applied? 12.9
13. Contract Activities
Is there a written procedure for selection and

Q 13.1 use of contractors for handling of 13.1 G13.1
pharmaceutical starting materials?
Does this procedure include safety and

Q 13.2 quality criteria for the selection of 13.2 G13.2
contractors?
If a sub distributor is supplied, are they

Q 13.3 signatories to a Responsible Care or 13.2 F7.2
Responsible Distribution program?
Does this procedure include performance

Q 13.4 13.2 G13.3
evaluation of these contractors?
Are contract acceptors evaluated to comply

13.2 G13.4
Q 13.5 with GTDP principles prior to entering into
13.3 F7.4
the contract?
Are contract acceptors periodically re- 13.3 G13.5

Q 13.6 evaluated according to GTDP principles? F7.4
Are contracts specifying the distribution of

13.1
Q 13.7 GTDP related task between contract giver
13.4
G13.6
and contract acceptor?
Is sub-contracting prohibited unless specific

Q 13.8 controls are performed? 13.5 F4.1.2

Page 28
Appendix Bibliography
[1] The IPEC Good Distribution Practice Audit Guideline for Pharmaceutical Excipients
The International Pharmaceutical Excipients Council, 2008
[2] SQAS Distributor / ESAD for Chemical Distributors, Questionnaire and Guidelines
CEFIC and FECC, March 2006
[3] SQAS Distributor / ESAD for Chemical Distributors, Questionnaire and Guidelines
CEFIC and FECC, April 2011
[4] The IPEC Good Distribution Practice Guide for Pharmaceutical Excipients
The International Pharmaceutical Excipients Council, 2006
[5] The Joint IPEC – PQG Good Manufacturing Practices Guide for Pharmaceutical Excipients
The International Pharmaceutical Excipients Council and Pharmaceutical Quality Group, 2006
[6] Good Trade and Distribution Practices for Pharmaceutical Starting Materials
World Health Organization, WHO Technical Report Series, No. 917, 2003
[7] Good Manufacturing Practices: Supplementary Guidelines for the Manufacture of

[8] IPEC Americas Good Distribution Practices Audit Guide for North American Distribution of
The International Pharmaceutical Excipients Council Americas, 2011
Additional references
Guide to Good Storage Practices for Pharmaceuticals

Good Manufacturing Practice for Active Pharmaceutical Ingredients (ICH Q7)

International Conference on Harmonisation, 2000
Model Certificate of Analysis


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Table of contents Page

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III. Pharmaceutical Grade Excipients

Copyright © 2011 The International Pharmaceutical Excipients Council - Europe

Is there a quality management system 1.1

Are the GTDP*/HACCP** principles part of

Is there a quality manual and written

Is there a third party certification of the

Is there a library of relevant regulations on

Is a person designated or a source defined to

Are responsibilities for assessing the impact

Copyright © 2011 The International Pharmaceutical Excipients Council - Europe

Does the company have a written policy

Q 1.10 Is the policy signed by top management? 1.1 G1.8

Does the company operate a documented

Is there a procedure for internal audits of the

Do those carrying out auditing have training

Is a formal management review of the

Do management reviews consider:

- findings of internal audits,

- the overall effectiveness of the system in

- opportunities for updating and/or

Do management reviews consider trends in

Copyright © 2011 The International Pharmaceutical Excipients Council - Europe

Does the distributor demonstrate his

Is there an adequate number personnel

Are there authorized release procedures in

Is there a copy of the manufacturers’

2. Organisation and Personnel

Has the company a sufficient number of

Have all (including administrative) personnel,

Have all (including administrative) personnel,

Are employees qualified according to GDP

Is there a specific qualification required for

Are the HSE responsible persons providing

Have job descriptions been made and

Has an evaluation been made of all activities 2.1

Are personnel qualified for GTDP relevant

Q 2.11 Is initial and ongoing training provided? 2.4

Q 2.12 Are GTDP principles part of regular training? 2.3 G2.4

Are employee training and qualification

Are internal and external training courses

Copyright © 2011 The International Pharmaceutical Excipients Council - Europe

Are contractors provided with information 2.2

Are there procedures in place ensuring good

Are areas where pharmaceutical starting

Are premises well constructed and in visibly

Are appropriate laboratory facilities

Has the site implemented security measures G3.3

Copyright © 2011 The International Pharmaceutical Excipients Council - Europe

Is there an effective pest control program in

Q 3.7 Is the warehouse well ventilated? 3.4 G4.7

Q 3.9 Is there adequate lighting in the warehouse? 3.4 G4.10

Is the design and operation of the air handling

Are the design, operation and maintenance of

If sampling is performed, are sampling areas

Is there a separate sampling area in a