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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

1. Introduction

The WHO Expert Committee on Specifications for Pharmaceutical Preparations met in Geneva from 30 November to 4 December 1992. The meeting was opened on behalf of the Director-General by Dr J.F. Dunne, Director, Division of Drug Management and Policies, who drew attention to some of the major aspects of the Expert Committee’s work over the previous 10 years. In so doing, he suggested that the overall objective of this work was to provide a solid foundation on which all interested Member States could build a comprehensive approach to quality assurance of pharmaceutical products. Since the previous meeting of the Committee, important changes had occurred in the world, especially in Europe. New independent states had emerged and many had joined the Organization. Dr Dunne asked the Expert Committee to bear the needs of these Member States in mind during its discussions and in recommending future action.

In May 1992, the World Health Assembly adopted resolution WHA 45.28, which requested the Director-General, inter alia, “to further the international harmonization of drug regulatory regimes”. Dr Dunne suggested that the aim should be to build on the results of current initiatives involving the countries of the European Communities, Japan and the United States of America to the advantage of the broader constituency of WHO’s Member States. He informed the Expert Committee that the administrative structure of the Division of Drug Management and Policies had been modified so as to make it better able to meet the challenges of the times. He was confident that it could provide the help needed by countries in establishing and maintaining appropriate drug regulatory systems.


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