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WHO Expert Committee on Specifications for Pharmaceutical Preparations - WHO Technical Report Series, No. 902 - Thirty-sixth Report
(2002; 219 pages) View the PDF document
Table of Contents
View the documentWHO Expert Committee on Specifications for Pharmaceutical Preparations
View the document1. Introduction
Open this folder and view contents2. Quality control - specifications and tests
Open this folder and view contents3. Quality control - reference materials
Open this folder and view contents4. Quality control - pharmaceutical control laboratories
Open this folder and view contents5. Quality assurance - good manufacturing practices
Open this folder and view contents6. Quality assurance - inspection
Open this folder and view contents7. Quality assurance - packaging
Open this folder and view contents8. Quality assurance - general topics
Open this folder and view contents9. Nomenclature and computerized systems
Open this folder and view contents10. Regulatory issues
View the documentAcknowledgements
View the documentReferences
View the documentAnnex 1 - List of available International Chemical Reference Substances1
View the documentAnnex 2 - List of available International Infrared Reference Spectra
Open this folder and view contentsAnnex 3 - Good practices for national pharmaceutical control laboratories
View the documentAnnex 4 - Considerations for requesting analysis of drug samples1
View the documentAnnex 5 - Basic elements of good manufacturing practices in pharmaceutical production
Open this folder and view contentsAnnex 6 - Good manufacturing practices for sterile pharmaceutical products
Open this folder and view contentsAnnex 7 - Guidelines on pre-approval inspections
Open this folder and view contentsAnnex 8 - Quality systems requirements for national good manufacturing practice inspectorates
Open this folder and view contentsAnnex 9 - Guidelines on packaging for pharmaceutical products
View the documentAnnex 10 - Model certificate of analysis
View the documentAnnex 11 - Guidance on the selection of comparator pharmaceutical products for equivalence assessment of interchangeable multisource (generic) products
View the documentAnnex 12 - Guidelines on the use of International Nonproprietary Names (INNs) for pharmaceutical substances
View the documentSelected WHO Publications of Related Interest
View the documentBack Cover

WHO Expert Committee on Specifications for Pharmaceutical Preparations - WHO Technical Report Series, No. 902 - Thirty-sixth Report

This report contains the collective views of on international group of experts and
does not necessarily represent the decisions or the stated policy of the World Health Organization

WHO Technical Report Series

World Health Organization
Geneva 2002

The World Health Organization was established in 1948 as a specialized agency of the United Nations serving as the directing and coordinating authority for international health matters and public health. One of WHO’S constitutional functions is to provide objective and reliable information and advice in the field of human health, a responsibility that it fulfils in part through its extensive programme of publications.

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The WHO Technical Report Series makes available the findings of various international groups of experts that provide WHO with the latest scientific and technical advice on a broad range of medical and public health subjects. Members of such expert groups serve without remuneration in their personal capacities rather than as representatives of governments or other bodies; their views do not necessarily reflect the decisions or the stated policy of WHO. An annual subscription to this series, comprising about 10 such reports, costs Sw. fr. 132.- (Sw. fr. 92.40 in developing countries).

WHO Library Cataloguing-in-Publication Data

WHO Expert Committee on Specifications for Pharmaceutical Preparations (1999: Geneva, Switzerland)
WHO Expert Committee on Specifications for Pharmaceutical Preparations: thirty-sixth report.
(WHO technical report series; 902)

1. Pharmaceutical preparations - standards 2. Technology, Pharmaceutical - standards
3. Quality control 4. Reference standards 5. Legislation, Drug 6. Guidelines I. Title II. Series

ISBN 92 4 120902 X

(NLM classification: QV 771)

ISSN 0512-3054


The World Health Organization welcomes requests for permission to reproduce or translate its publications, in part or in full. Applications and enquiries should be addressed to the Office of Publications, World Health Organization, Geneva, Switzerland, which will be glad to provide the latest information on any changes made to the text, plans for new editions, and reprints and translations already available.

© World Health Organization 2002

Publications of the World Health Organization enjoy copyright protection in accordance with the provisions of Protocol 2 of the Universal Copyright Convention. Alt rights reserved.

The designations employed and the presentation of the material in this publication do not imply the expression of any opinion whatsoever on the part of the Secretariat of the World Health Organization concerning the legal status of any country, territory, city or area or of its authorities, or concerning the delimitation of its frontiers or boundaries.

The mention of specific companies or of certain manufacturers’ products does not imply that they are endorsed or recommended by the World Health Organization in preference to others of a similar nature that are not mentioned. Errors and omissions excepted, the names of proprietary products are distinguished by initial capital letters.

Typeset in Hong Kong
Printed in Singapore
2001/13671 - Best-set/SNP - 6000

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