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WHO Expert Committee on Specifications for Pharmaceutical Preparations - WHO Technical Report Series, No. 834 - Thirty-third Report
(1993; 36 pages) 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 activities
Open this folder and view contents3. International Chemical Reference Substances and International Infrared Reference Spectra
View the document4. Quality control methods for medicinal plant materials
View the document5. The WHO Certification Scheme on the Quality of Pharmaceutical Products Moving in International Commerce
Open this folder and view contents6. Good manufacturing practices for pharmaceutical products
View the document7. Development of globally acceptable standards for excipients
Open this folder and view contents8. Stability of dosage forms
View the document9. Simple test methodology
View the document10. Quality assurance in pharmaceutical supply systems
Open this folder and view contents11. Pharmaceutical production in developing countries
View the document12. Training
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 Spectra
Open this folder and view contentsAnnex 3 - Good manufacturing practices for biological products1
View the documentBack Cover
 

Back Cover

This report presents the recommendations of an international group of experts convened by the World Health Organization to consider matters concerning the quality assurance of Pharmaceuticals and specifications for drug substances and dosage forms. Of particular relevance to drug regulatory authorities, the report discusses various topics relevant to the development of The international pharmacopoeia, including methods of ensuring the therapeutic equivalence of multisource products, as well as issues relating to the stability of dosage forms and the certification of active ingredients. Consideration is also given to pharmaceutical production in developing countries and to training in the administrative aspects of drug control, in particular in support of the drug registration process. Annexed to the report are recommendations on good manufacturing practices for biological products and lists of available International Chemical Reference Substances and International Infrared Reference Spectra.

Price: Sw. fr. 7. -

 

Price in developing countries: Sw. fr. 4.90

ISBN 92 4120834 1

 

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