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IPEC Good Distribution Practices Audit Guideline

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IPEC Good Distribution Practices Audit Guideline FOR PHARMACEUTICAL EXCIPIENTS 2008 This document has been written to provide a tool for those auditing companies involved in the supply chain of pharmaceutical excipients. This Audit Questionnaire should be used in conjunction with the IPEC Good Distribution Practices Guide. The explanatory notes in this questionnaire are provided to help the auditor obtain the maximum benefit in its application. This Questionnaire replaces the IPEC GMP Audit Guideline for Distributors of Bulk Pharmaceutical Excipients (2000).

     The

     IPEC

    Good Distribution

     Practices

    Audit Guideline

    FOR

    PHARMACEUTICAL

    EXCIPIENTS

    2008

    Copyright ? 2008 The International Pharmaceutical Excipients Council

    IPEC Good Distribution Practices Audit Questionnaire 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 Questionnaire should be used in conjunction with the IPEC Good Distribution Practices

    Guide.

The explanatory notes in this questionnaire are provided to help the auditor obtain the maximum benefit

    in its application.

    This Questionnaire replaces the IPEC GMP Audit Guideline for Distributors of Bulk Pharmaceutical Excipients (2000).

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 ...................................................................................................................................... 9

    4. Warehousing and Storage ........................................................................................................... 11

    5. Equipment ................................................................................................................................. 15

    6. Documentation........................................................................................................................... 18

    7. Repackaging and re labelling...................................................................................................... 21

    8. Complaints................................................................................................................................. 26

    9. Recalls ....................................................................................................................................... 27

    10. Returned Goods ........................................................................................................................ 28

    11. Handling of non-conforming materials ...................................................................................... 28

    12. Dispatch and Transport ............................................................................................................. 29

    13. Contract Activities .................................................................................................................... 31

    Appendix Bibliography ................................................................................................................. 33

    Copyright ? 2008 The International Pharmaceutical Excipients Council

    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 Questionnaire was designed as a tool to

    assist in evaluating the practices and quality systems of distributors who sell, store or repackage, (or any combination thereof) excipients. During 2001, and again in 2006, IPEC revised its GMP Guidelines for manufacturers of excipients and decided to publish a complementary document for distributors of excipients.

    For the purpose of this guide “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 that other questionnaires are available and widely applied throughout the distribution industry. With this in mind, IPEC has used many of the questions used in the Safety and Quality Assessment Scheme - SQAS Distributor (ESAD II, primarily Section F and Sub Section G) Questionnaire, in order to maintain consistency. Wherever possible, original ESAD II questions have been used. However, there are occasions when the IPEC GDP Guide has additional questions not referenced in the ESAD II questionnaire and vice versa. In this way, the questionnaire may be used for auditing against one or the other (or both) Guides.

For definition of technical terms, please refer to the Glossary in the IPEC Good Distribution Practices

    Guide [7].

    More information on the SQAS 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 [2].

II. Scope

    This Questionnaire is linked to the IPEC Good Distribution Practices Guide (based on the WHO Good

    Trade and Distribution Practices for Pharmaceutical Starting Materials), 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 [2], WHO Excipient GMP [6]). 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.

    Copyright ? 2008 The International Pharmaceutical Excipients Council

    Page 2

IV. Acknowledgements

    The International Pharmaceutical Excipients Council (IPEC) prepared this document. IPEC is an international industry association with a distinguished worldwide membership of chemical, pharmaceutical and food firms that develop, manufacture, distribute, sell and use pharmaceutical excipients. IPEC was formed in 1991 to address prevalent industry concerns related to the harmonization of international excipient standards, the introduction of useful new excipients to the marketplace, and the development of good manufacturing practices for excipients. IPEC is an umbrella organization comprised of three regional pharmaceutical excipient industry associations in the United States, Europe, and Japan. The objective of the three organizations, known respectively as IPEC Americas, IPEC-Europe and JPEC, is to promote the safety and efficacy of finished dosage forms worldwide.

    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

    Dr. Steven Hewitt sanofi aventis

    Dr. Andreas Lekebusch Biesterfeld Spezialchemie GmbH

    George Mansveld Hercules International Ltd.

    Dr. Frank Milek Aug. Hedinger GmbH & Co. KG

    Allan Whiston QA Resolutions Ltd. GDP Committee Chairman

    Copyright ? 2008 The International Pharmaceutical Excipients Council

    Page 3

    Refer to Refer to

    IPEC GDP SQAS Question Question Guide Distributor Notes Number section... ESAD II

    section...

     1. Quality Management

     Is there a quality management system 1.1, 1.2, 1.3 G1.1

    implemented (Covered by an ISO 9001:2000 Q 1.1

    certification)?

     Is there a quality manual and written 1.2

    procedures describing all *GTDP related Q 1.2 processes?

    * Good Trade and Distribution Practices

     Is there a third party certification of the 1.8 G1.2

    quality system (Covered by ISO 9001:2000 Q 1.3 certification or third party HACCP verification)?

     Is there a library of relevant regulations on 1.1 G1.3 Q 1.4 starting materials for pharmaceuticals?

     Is a person designated or a source defined to 1.1 G1.4

    keep the company informed about legislative Q 1.5 developments in the area of starting materials

    for pharmaceuticals?

     Are responsibilities for assessing the impact 1.1 G1.5

    of such legislative developments and for Q 1.6 proposing actions to comply with these clearly defined?

     Is a regular review made of the system for 1.1 G1.6 Q 1.7 compliance with legal requirements?

    Copyright ? 2008 The International Pharmaceutical Excipients Council

    Page 4

    Refer to Refer to

    IPEC GDP SQAS Question Question Guide Distributor Notes Number section... ESAD II

    section...

     Does the company have a written policy 1.1 G1.7 including management's active commitment Q 1.8

    to Quality?

     Is the policy signed by top management? 1.1 G1.8 Q 1.9

     Does the company operate a documented 11.1 G1.9 Q 1.10 system for quarantining suspect product?

     Is there a procedure for internal audits of the 1.9 G1.10 Q 1.11 management system including an audit plan?

     Do those carrying out auditing have training 2.2 G1.11 Q 1.12 in auditing and evaluation techniques?

     Is a formal management review of the 1.9 G1.12 Quality Management System held at least Q 1.13

    once a year?

     Do management reviews consider:

     - findings of internal audits, 1.9 G1.13a recommendations made and corrective Q 1.14

    actions taken?

     - the overall effectiveness of the system in 1.2 G1.13b Q 1.15 achieving quality objectives?

     - opportunities for updating and/or 1.9 G1.13c Q 1.16 improving the system?

    Do management reviews consider trends in 1.2 G1.14 Q 1.17 customer complaints?

    Copyright ? 2008 The International Pharmaceutical Excipients Council

    Page 5

    Refer to Refer to

    IPEC GDP SQAS Question Question Guide Distributor Notes Number section... ESAD II

    section... Do management reviews consider trends in 1.2 G1.15 Q 1.18 non-conformance claims?

    Does the distributor demonstrate his 1.4 F7.1 responsibilities to assure compliance with Q 1.19 Product Stewardship principles along the entire supply chain?

    Is there an adequate number of qualified 1.5 personnel available either in-house or Q 1.20 contracted out to carry out all the operations

    in compliance with the IPEC GDP Guide?

    Are there authorized release procedures in 1.7 Q 1.21 place?

    Is there a copy of the manufacturers 1.7 documents (such as COA or COC) supplied Q 1.22

    with each delivery?

     2. Organisation and Personnel

    Has the company a sufficient number of 2.1 F1.2.1 Q 2.1 qualified employees for these operations?

    Have all (including administrative) 2.2 F1.2.2 personnel, involved in handling and

    distributing Food, Cosmetic or/and Pharma Q 2.2

    grade products been made aware of the risks

    for human health?

    Copyright ? 2008 The International Pharmaceutical Excipients Council

    Page 6

    Refer to Refer to

    IPEC GDP SQAS Question Question Guide Distributor Notes Number section... ESAD II

    section... Have all (including administrative) 2.4 F1.2.3 personnel, involved in handling and distributing Food, Cosmetic or/and Pharma Q 2.3

    grade products been formally qualified

    according to written criteria?

    Is there a person with the specific 2.1 F1.2.4 responsibility and the appropriate authority to Q 2.4 deal with GMP (GTDP) issues in the

    company?

    Are there enough employees involved in 2.1 F1.2.5 GMP (GTDP) operations related to the Food, Q 2.5

    Cosmetic and Pharma business?

    Are these employees qualified according to 2.3 F1.2.6 Q 2.6 GMP (GTDP) requirements?

    Is there a specific qualification required for 2.5 F1.2.7 employees responsible for key activities in Q 2.7 Safety, Health, Environment (HSE) and

    Quality?

    Are the HSE responsible persons providing 2.5 regular training to employees dealing with Q 2.8

    hazardous materials?

    Have job descriptions been made and 2.2 G2.1 Q 2.9 regularly updated?

    Has an evaluation been made of all activities 2.1, 2.2 G2.2 Q 2.10 to identify training needs?

    Copyright ? 2008 The International Pharmaceutical Excipients Council

    Page 7

    Refer to Refer to

    IPEC GDP SQAS Question Question Guide Distributor Notes Number section... ESAD II

    section... Are there qualified personnel for GTDP 2.2 G2.3 relevant operations with specific (technical) Q 2.11

    background/education?

    Is there initial and ongoing training 2.4 Q 2.12 provided?

    Are GTDP principles part of regular training? 2.3 G2.4 Q 2.13 Are employee training and qualification 2.4 G2.5 Q 2.14 records maintained?

    Are internal and external training courses 2.4 G2.6 documented? Q 2.15 (Documentation of training should include records of training effectiveness.)

    Are contracted service providers included in 2.2 Q 2.16 the training program?

    Are contractors provided with information 2.2, 2.3 G13.7a Q 2.17 relevant to the job to be done?

     Are contractors provided with appropriate 2.2, 2.3 G13.7b Q 2.18 training if necessary?

    Are contractors provided with appropriate 2.5 G13.7c Q 2.19 personal protective equipment?

    Copyright ? 2008 The International Pharmaceutical Excipients Council

    Page 8

    Refer to Refer to

    IPEC GDP SQAS Question Question Guide Distributor Notes Number section... ESAD II

    section... Are there procedures in place ensuring good 2.6 G2.7 hygiene of the personnel where exposure to

    material in open containers may occur (e.g. Q 2.20

    monitoring of health conditions, wearing of protective clothes etc.)?

     3. Premises

    Are areas where pharmaceutical starting 3.1 G3.1 materials are handled designed and operated

    in a way to ensure cleanliness, appropriate Q 3.1

    hygiene and a minimisation of cross-

    contamination risks?

    Are premises well constructed and in visibly 3.1 G3.2 Q 3.2 good condition?

    Has the site implemented security measures 3.2 G3.3, Q 3.3 to control access of unauthorized persons? S1.1.1 Are the premises designed, operated, and 3.3 maintained to avoid infestation by rodents, Q 3.4

    birds, insects, and other vermin?

    Is there an effective pest control program in 3.3 G3.4 Q 3.5 place?

    Is the warehouse well ventilated? 3.4 G4.7 Q 3.6 If a heating/air-conditioning system is 3.4 G4.8 installed is it compatible with the stored Q 3.7

    products?

    Copyright ? 2008 The International Pharmaceutical Excipients Council

    Page 9

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