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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] View the PDF document
Table of Contents
View the documentWHO Expert Committee on Specifications for Pharmaceutical Preparations
View the document1. Introduction
Open this folder and view contents2. The international pharmacopoeia and related issues
Open this folder and view contents3. International Chemical Reference Substances and Infrared Reference Spectra
Open this folder and view contents4. Quality control - national laboratories
Open this folder and view contents5. Good manufacturing practices
Open this folder and view contents6. Quality systems and inspection
Open this folder and view contents7. Other quality assurance topics
Open this folder and view contents8. Nomenclature and terminology
Open this folder and view contents9. Legal aspects of pharmaceuticals
Open this folder and view contents10. Regulatory issues
Open this folder and view contents11. Training activities
View the document12. Pharmaceuticals contaminated with diethylene glycol
View the documentAcknowledgements
View the documentReferences
View the documentAnnex 1. List of available International Chemical Reference Substances1
View the documentAnnex 2. List of available International Infrared Reference Spectra1
Open this folder and view contentsAnnex 3. General guidelines for the establishment, maintenance and distribution of chemical reference substances
Open this folder and view contentsAnnex 4. Good manufacturing practices: authorized person - role, functions and training
Open this folder and view contentsAnnex 5. Good manufacturing practices: supplementary guidelines for the manufacture of pharmaceutical excipients
Open this folder and view contentsAnnex 6. Guidelines for inspection of drug distribution channels
View the documentAnnex 7. Good pharmacy practice in community and hospital pharmacy settings
Open this folder and view contentsAnnex 8. National drug regulatory legislation: guiding principles for small drug regulatory authorities
Open this folder and view contentsAnnex 9. Provisional guidelines for developing training programmes: inspection and examination of counterfeit pharmaceuticals
View the documentWorld Health Organization Technical Report Series
View the documentSelected WHO Publications of Related Interest
View the documentBack Cover
 

Back Cover

The production, distribution and sale of counterfeit or substandard pharmaceutical products on the world market are of increasing concern to drug authorities and the international agencies that recommend standards for ensuring the quality, efficacy and safety of drugs.

This report of an international group of experts convened by the World Health Organization presents recommendations concerning the quality assurance of pharmaceuticals and specifications for drug substances and dosage forms. It looks at activities related to the further development of The international pharmacopoeia and also covers good manufacturing practices, inspection and monitoring, and drug regulatory legislation.

The aim of the report, of particular relevance to drug regulatory authorities, is to provide guidance to promote harmonization at an international level and encourage countries to establish and strengthen their own regulatory systems through national legislation and training programmes. A number of annexes attached to the report further develop areas where countries might themselves take action, and include detailed examples of provisional legislation and guidelines on specific aspects of good manufacturing practice, the inspection of drug distribution channels, and the development of training programmes for the inspection and examination of counterfeit pharmaceuticals.

Price: Sw. fr. 35.-
Price in developing countries: Sw. fr. 24.50
ISBN 92 4 120885 6

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