Thirty-sixth report / WHO Expert Committee on Specifications for Pharmaceutical Preparations.

Format:

Book

Government document

Author/Creator:

WHO Expert Committee on Specifications for Pharmaceutical Preparations.

Series:

Technical report series (World Health Organization) ; 902.

WHO Technical report series, 0512-3054 ; 902

Language:

English

Subjects (All):

Pharmacopoeias--Standards.

Pharmacopoeias.

Drugs.

Physical Description:

1 online resource (216 p.)

Edition:

1st ed.

Place of Publication:

Geneva : World Health Organization, 2002.

Language Note:

English

Summary:

This report sets out a series of 12 international guidelines and other recommendations intended to assist national drug regulatory authorities and manufacturers in the quality assurance of pharmaceutical products. The report also responds to the need to extend previously issued WHO guidelines for good manufacturing practices (GMP) to cover several special circumstances as well as guidance for inspectorates.

Contents:

Thirty-sixth Report

Contents

Introduction

Quality control - specifications and tests

Quality control - reference materials

Quality control - pharmaceutical control laboratories

Quality assurance - good manufacturing practices

Quality assurance - inspection

Quality assurance - packaging

Quality assurance - general topics

Nomenclature and computerized systems

Regulatory issues

Acknowledgements

References

Annex 1 List of available International Chemical Reference Substances

Annex 2 List of available International Infrared Reference Spectra

Annex 3 Good practices for national pharmaceutical control laboratories

Part One. Management and infrastructure

Part Two. Materials and setting-up of equipment, instruments and other devices

Part Three. Working procedures

Part Four. Safety

Appendix 1 Model analytical test report for active pharmaceutical ingredients, excipients and pharmaceutical products

Appendix 2 Equipment for a first-stage and medium-size pharmaceutical control laboratory

Annex 4 Considerations for requesting analysis of drug samples

Annex 5 Basic elements of good manufacturing practices in pharmaceutical production

Annex 6 Good manufacturing practices for sterile pharmaceutical products

Annex 7 Guidelines on pre-approval inspections

Annex 8 Quality systems requirements for national good manufacturing practice inspectorates

Annex 9 Guidelines on packaging for pharmaceutical products

Appendix 1 Storage Areas

Appendix 2 Labels

Appendix 3 Self- inspection and quality audits

Appendix 4 International standards on packaging

Annex 10 Model certificate of analysis

Appendix 1 Model certificate of analysis for active pharmaceutical ingredients, excipients and medicinal products.

Annex 11 Guidance on the selection of comparator pharmaceutical products for equivalence assessment of interchangeable multisource (generic) products

Annex 12 Guidelines on the use of International Nonproprietary Names (INNs) for pharmaceutical substances

Appendix 1 List of common stems used in the selection of INNs

Appendix 2 Common stems that have been discontinued.

Notes:

"WHO Expert Committee on Specifications for Pharmaceutical Preparations met in Geneva from 31 May to 4 June 1999"--p. v.

Includes bibliographical references.

ISBN:

1-280-04127-7

9786610041275

OCLC:

70764173