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WHO Expert Committee on Specifications for Pharmaceutical Preparations - WHO Technical Report Series, No. 908 - Thirty-seventh Report
(2003; 148 pages) 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. General policy
Abrir esta carpeta y ver su contenido3. Quality control - specifications and tests
Ver el documento4. Quality control - international reference materials
Abrir esta carpeta y ver su contenido5. Quality control - national laboratories
Abrir esta carpeta y ver su contenido6. Quality assurance - good manufacturing practices
Abrir esta carpeta y ver su contenido7. Quality assurance - inspection
Abrir esta carpeta y ver su contenido8. Quality assurance - distribution and trade-related
Abrir esta carpeta y ver su contenido9. Quality assurance - risk analysis
Abrir esta carpeta y ver su contenido10. Quality assurance - drug supply
Abrir esta carpeta y ver su contenido11. Quality assurance - storage
Ver el documento12. International Nonproprietary Names (INNs) programme
Abrir esta carpeta y ver su contenido13. Miscellaneous
Ver el documentoAcknowledgements
Ver el documentoReferences
Ver el documentoAnnex 1 Recommendations on risk of transmitting animal spongiform encephalopathy agents via medicinal products
Ver el documentoAnnex 2 The International Pharmacopoeia: revised concepts and future perspectives
Abrir esta carpeta y ver su contenidoAnnex 3 Guidelines on Good Manufacturing Practices for radiopharmaceutical products
Abrir esta carpeta y ver su contenidoAnnex 4 Good Manufacturing Practices for pharmaceutical products: main principles
Ver el documentoAnnex 5 Model certificate of Good Manufacturing Practices
Ver el documentoAnnex 6 Guidance on Good Manufacturing Practices (GMP): inspection report
Ver el documentoAnnex 7 Application of Hazard Analysis and Critical Control Point (HACCP) methodology to pharmaceuticals
Abrir esta carpeta y ver su contenidoAnnex 8 Procedure for assessing the acceptability, in principle, of pharmaceutical products for purchase by United Nations agencies
Abrir esta carpeta y ver su contenidoAnnex 9 Guide to good storage practices for pharmaceuticals1
Ver el documentoBack cover
 

WHO Expert Committee on Specifications for Pharmaceutical Preparations - WHO Technical Report Series, No. 908 - Thirty-seventh Report

WHO Technical Report Series
908

World Health Organization
Geneva

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 six such reports, costs Sw. fr. 132. - or US$ 106. - (Sw. fr. 92.40 in developing countries). For further information, please contact Marketing and Dissemination, World Health Organization, 20 avenue Appia, 1211 Geneva 27, Switzerland (tel.: +41 22 791 2476; fax: +41 22 791 4857; e-mail: bookorders@who.int).

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

WHO Library Cataloguing-in-Publication Data

WHO Expert Committee on Specifications for Pharmaceutical Preparations (2001: Geneva, Switzerland) WHO Expert Committee on Specifications for Pharmaceutical Preparations: thirty-seventh report.

(WHO technical report series; 908)

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

ISBN 92 4 120908 9
(NLM classification: QV 771)
ISSN 0512-3054

© World Health Organization 2003

All rights reserved. Publications of the World Health Organization can be obtained from Marketing and Dissemination, World Health Organization, 20 Avenue Appia, 1211 Geneva 27, Switzerland (tel: +41 22 791 2476; fax: +41 22 791 4857; email: bookorders@who.int). Requests for permission to reproduce or translate WHO publications - whether for sale or for noncommercial distribution - should be addressed to Publications, at the above address (fax: +41 22 791 4806; email: permissions@who.int).

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 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. Dotted lines on maps represent approximate border lines for which there may not yet be full agreement.

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.

The World Health Organization does not warrant that the information contained in this publication is complete and correct and shall not be liable for any damages incurred as a result of its use.

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

Typeset in Hong Kong
Printed in Singapore
2002/14377 - SNPBest-set/SNP - 7000

 

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