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WHO Expert Committee on Specifications for Pharmaceutical Preparations - WHO Technical Report Series, No. 863 - Thirty-fourth Report
(1996; 200 pages) Ver el documento en el formato PDF
Índice de contenido
Ver el documento1. Introduction
Abrir esta carpeta y ver su contenido2. The international pharmacopoeia and related activities
Ver el documento3. Simple test methodology
Abrir esta carpeta y ver su contenido4. Stability of dosage forms
Abrir esta carpeta y ver su contenido5. Good manufacturing practices for pharmaceutical products
Abrir esta carpeta y ver su contenido6. Legal and administrative aspects of the functioning of national drug regulatory authorities
Abrir esta carpeta y ver su contenido7. Quality assurance in the supply system
Ver el documento8. Terminology
Ver el documentoAcknowledgements
Ver el documentoReferences
Abrir esta carpeta y ver su contenidoAnnex 1 - Guidelines for the graphic representation of chemical formulae
Ver el documentoAnnex 2 - List of available International Chemical Reference Substances1
Ver el documentoAnnex 3 - List of available International Infrared Reference Spectra
Abrir esta carpeta y ver su contenidoAnnex 4 - General recommendations for the preparation and use of infrared spectra in pharmaceutical analysis
Abrir esta carpeta y ver su contenidoAnnex 5 - Guidelines for stability testing of pharmaceutical products containing well established drug substances in conventional dosage forms
Abrir esta carpeta y ver su contenidoAnnex 6 - Good manufacturing practices: guidelines on the validation of manufacturing processes
Abrir esta carpeta y ver su contenidoAnnex 7 - Good manufacturing practices: supplementary guidelines for the manufacture of investigational pharmaceutical products for clinical trials in humans
Abrir esta carpeta y ver su contenidoAnnex 8 - Good manufacturing practices: supplementary guidelines for the manufacture of herbal medicinal products1
Abrir esta carpeta y ver su contenidoAnnex 9 - Multisource (generic) pharmaceutical products: guidelines on registration requirements to establish interchangeability
Abrir esta carpeta y ver su contenidoAnnex 10 - Guidelines for implementation of the WHO Certification Scheme on the Quality of Pharmaceutical Products Moving in International Commerce
Abrir esta carpeta y ver su contenidoAnnex 11 - Guidelines for the assessment of herbal medicines1,2
Abrir esta carpeta y ver su contenidoAnnex 12 - Guidelines on import procedures for pharmaceutical products
Ver el documentoBack Cover

WHO Expert Committee on Specifications for Pharmaceutical Preparations - WHO Technical Report Series, No. 863 - Thirty-fourth Report

Who Technical Report Series

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

World Health Organization
Geneva 1996

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.

The Organization seeks through its publications to support national health strategies and address the most pressing public health concerns of populations around the world. To respond to the needs of Member States at all levels of development, WHO publishes, practical manuals, handbooks and training material for specific categories of health workers; internationally applicable guidelines and standards; reviews and analyses of health policies, programmes and research; and state-of-the-art consensus reports that offer technical advice and recommendations for decision-makers. These books are closely tied to the Organization's priority activities, encompassing disease prevention and control, the development of equitable health systems based on primary health care, and health promotion for individuals and communities. Progress towards better health for all also demands the global dissemination and exchange of information that draws on the knowledge and experience of all WHO's Member countries and the collaboration of world leaders in public health and the biomedical sciences.

To ensure the widest possible availability of authoritative information and guidance on health matters, WHO secures the broad international distribution of its publications and encourages their translation and adaptation. By helping to promote and protect health and prevent and control disease throughout the world, WHO's books contribute to achieving the Organization's principal objective - the attainment by all people of the highest possible level of health.

- - - - - - - - -

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. 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
(34th: 1994: Geneva, Switzerland)
WHO Expert Committee on Specifications for Pharmaceutical
Preparations: thirty-fourth report.

(WHO technical report series; 863)

1. Drug industry 2. Drugs - standards 3. Quality control 4. Legislation, Drug 5. Guidelines
I. Title II. Series

ISBN 92 4 120863 5

(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 1996

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

The designations employed and the presentation of the material in this publication do not imply the expression of any opinion whatsoever op 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.

Printed in Switzerland
95/10779 -Benteli- 6700

WHO Expert Committee on Specifications for Pharmaceutical Preparations

Geneva, 28 November-2 December 1994


Dr T. Layloff, Director, Division of Drug Analysis. Food and Drug Administration, St Louis, MO, USA

Dr M. K. Majumdar, Director, Central Drugs Laboratory, WHO Collaborating Centre for Quality Assurance of Essential Drugs, Calcutta, India

Dr G. L. Mattok, Chief, Pharmaceutical Chemistry Division, Bureau of Drug Research, Health Protection Branch, Ottawa, Ontario, Canada

Dr E. Njau, Pharmaceutical Adviser, MEDIPHARMA GmbH, Arusha, United Republic of Tanzania

Professor T.L. Paál, Director-General, National Institute of Pharmacy, Budapest, Hungary (Chairman)

Miss M. L. Rabouhans, Deputy Secretary, British Pharmacopoeia Commission, London, England (Rapporteur)

Dr M.F. Saffar, Chief Inspector, Technical Vice-Director, National Drug Quality Control Laboratory, Ministry of Health, Tunis, Tunisia

Professor T. Sodogandji, Department of Pharmacology, Faculty of Health Sciences, National University of Benin, Cotonou, Benin

Professor Yang Zhong-Yuan, Director, Guangzhou Municipal Institute for Drug Control, Guangzhou, China (Vice-Chairman)

Representatives of other organizations*

* Unable to attend: Commission of the European Communities (CEC), Brussels, Belgium; United Nations Industrial Development Organization (UNIDO), Vienna, Austria; United Nations International Drug Control Programme (UNDCP). Vienna, Austria.

Commonwealth Pharmaceutical Association (CPA) and International Pharmaceutical Federation (FIP)

Professor H. Blume, Head, Central Laboratory of German Pharmacists, Eschborn, Germany

Council of Europe

Dr J. H. Miller, Head, European Pharmacopoeia Laboratory, Technical Secretariat of the European Pharmacopoeia, Strasbourg, France

European Free Trade Association (EFTA) and Pharmaceutical Inspection Convention (PIC)

Mr G. H. Besson, Senior Legal Officer. EFTA Secretariat and Secretary, Pharmaceutical Inspection Convention and Pharmaceutical Evaluation Report Scheme, Geneva, Switzerland

International Federation of Pharmaceutical Manufacturers Associations (IFPMA)

Miss M. Cone, Vice-President for Scientific Affairs, Geneva, Switzerland
Dr O. Morin, Scientific Executive, Geneva, Switzerland

United Nations Children's Fund (UNICEF)

Dr P. Carlevaro, Senior Adviser, Essential Drugs. New York, NY, USA

World Federation of Proprietary Medicine Manufacturers (WFPMM)

Dr J. A. Reinstein, Director-General, London, England


Dr J.F. Dunne, Director, Division of Drug Management and Policies, WHO, Geneva, Switzerland

Dr E. Ehrin, Quality Control Manager, Apoteksbolaget AB, Central Laboratory, National Corporation of Swedish Pharmacies, Stockholm, Sweden (Temporary Adviser)

Dr A.P. Mechkovski, Chief, Quality Assurance, Division of Drug Management and Policies, WHO, Geneva, Switzerland (Co-Secretary)

Ms A. Wehrli, Chief, Regulatory Support, Division of Drug Management and Policies, WHO, Geneva, Switzerland (Co-Secretary)

Dr C. Wongpinairat, Director, Division of Drug Analysis, Department of Medical Sciences, Ministry of Public Health, Nonthaburi, Thailand (Temporary Adviser)


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