(1996; 200 pages)
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
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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)
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© World Health Organization 1996
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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)