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Quality Assurance of Pharmaceuticals - A Compendium of Guidelines and Related Materials - Volume 1
(1997; 248 pages) [French] Ver el documento en el formato PDF
Índice de contenido
Abrir esta carpeta y ver su contenidoIntroduction
Abrir esta carpeta y ver su contenido1. National drug regulation
Abrir esta carpeta y ver su contenido2. Product assessment and registration
Abrir esta carpeta y ver su contenido3. Distribution
Abrir esta carpeta y ver su contenido4. The international pharmacopoeia and related activities
Abrir esta carpeta y ver su contenido5. Basic tests
Abrir esta carpeta y ver su contenido6. Laboratory services
Abrir esta carpeta y ver su contenido7. International trade in pharmaceuticals
Abrir esta carpeta y ver su contenido8. Counterfeit products
Abrir esta carpeta y ver su contenido9. Training
Ver el documentoSelected WHO publications of related interest
Ver el documentoBack cover

Quality Assurance of Pharmaceuticals - A Compendium of Guidelines and Related Materials - Volume 1

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
5. Guidelines


ISBN 92 4 154504 6

(NLM Classification: QV 33)

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 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

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.


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