World Health Organization
WHO Library Cataloguing in Publication Data
Quality assurance of pharmaceuticals: a compendium of guidelines and related materials: volume 1.
1. Drug and narcotic control
2. Drug industry - standards
3. Legislation, Drug
4. Quality control
ISBN 92 4 154504 6
(NLM Classification: QV 33)
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© World Health Organization 1997
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 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.
Much of the material reproduced in this publication is extracted from the reports of the WHO Expert Committee on Specifications for Pharmaceutical Preparations. These reports contain the collective views of an international group of experts and do not necessarily represent the decisions or the stated policy of the World Health Organization.
Printed in England
95/10460 - Clays - 8000
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