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WHO Expert Committee on Specifications for Pharmaceutical Preparations - WHO Technical Report Series, No. 885 - Thirty-fifth Report
(1999; 168 pages) [Spanish] Ver el documento en el formato PDF
Índice de contenido
Ver el documentoWHO Expert Committee on Specifications for Pharmaceutical Preparations
Ver el documento1. Introduction
Abrir esta carpeta y ver su contenido2. The international pharmacopoeia and related issues
Abrir esta carpeta y ver su contenido3. International Chemical Reference Substances and Infrared Reference Spectra
Abrir esta carpeta y ver su contenido4. Quality control - national laboratories
Abrir esta carpeta y ver su contenido5. Good manufacturing practices
Abrir esta carpeta y ver su contenido6. Quality systems and inspection
Abrir esta carpeta y ver su contenido7. Other quality assurance topics
Abrir esta carpeta y ver su contenido8. Nomenclature and terminology
Abrir esta carpeta y ver su contenido9. Legal aspects of pharmaceuticals
Abrir esta carpeta y ver su contenido10. Regulatory issues
Abrir esta carpeta y ver su contenido11. Training activities
Ver el documento12. Pharmaceuticals contaminated with diethylene glycol
Ver el documentoAcknowledgements
Ver el documentoReferences
Ver el documentoAnnex 1. List of available International Chemical Reference Substances1
Ver el documentoAnnex 2. List of available International Infrared Reference Spectra1
Abrir esta carpeta y ver su contenidoAnnex 3. General guidelines for the establishment, maintenance and distribution of chemical reference substances
Abrir esta carpeta y ver su contenidoAnnex 4. Good manufacturing practices: authorized person - role, functions and training
Abrir esta carpeta y ver su contenidoAnnex 5. Good manufacturing practices: supplementary guidelines for the manufacture of pharmaceutical excipients
Abrir esta carpeta y ver su contenidoAnnex 6. Guidelines for inspection of drug distribution channels
Ver el documentoAnnex 7. Good pharmacy practice in community and hospital pharmacy settings
Abrir esta carpeta y ver su contenidoAnnex 8. National drug regulatory legislation: guiding principles for small drug regulatory authorities
Abrir esta carpeta y ver su contenidoAnnex 9. Provisional guidelines for developing training programmes: inspection and examination of counterfeit pharmaceuticals
Ver el documentoWorld Health Organization Technical Report Series
Ver el documentoSelected WHO Publications of Related Interest
Ver el documentoBack Cover
 

WHO Expert Committee on Specifications for Pharmaceutical Preparations - WHO Technical Report Series, No. 885 - Thirty-fifth Report

WHO Technical Report Series
885


World Health Organization
Geneva 1999

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

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; 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 (1997: Geneva, Switzerland) WHO Expert Committee on Specifications for Pharmaceutical Preparations: thirty-fifth report.

(WHO technical report series: 885)

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

ISBN 92 4 120885 6 (Classification NLM: 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 1999

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.

Typeset In Hong Kong
Printed in Spain

98/12121 - Best-set/Fotojae - 6500

 

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