ISBN-10:
9241209534
ISBN-13:
9789241209533
Pub. Date:
08/28/2009
Publisher:
World Health Organization
WHO Expert Committee on Specifications for Pharmaceutical Preparations: Forty-Third Meeting

WHO Expert Committee on Specifications for Pharmaceutical Preparations: Forty-Third Meeting

by World Health Organization

Paperback

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Product Details

ISBN-13: 9789241209533
Publisher: World Health Organization
Publication date: 08/28/2009
Series: WHO Technical Report Series
Pages: 152
Product dimensions: 6.20(w) x 9.40(h) x 0.40(d)

About the Author

World Health Organization is a Specialized Agency of the United Nations, charged to act as the world's directing and coordinating authority on questions of human health. It is responsible for providing leadership on global health matters, shaping the health research agenda, setting norms and standards, articulating evidence-based policy options, providing technical support to countries and monitoring and assessing health trends.

Table of Contents

Expert Committee on Specifications for Pharmaceutical Preparations (Members, Advisors and Organizations)
Declarations of Interest
1) Introduction
2) General Policy
3) Joint Session with the Expert Committee on Biological Standardization
4) Quality Control - Specifications and Tests
5) Quality Conctrol - International Reference Materials
6) Quality Control - National Laboratories
7) Quality Assurance - Good Manufacturing Practices
8) Quality Assurance - New Approachs and Risk Analysis
9) Quality Assurance - Distribution and Trade of Pharmaceuticals
10) Quality Assurance - Stability
11) Prequalification of Priority Essential Medicines and Devices
12) Prequalification of Quality Control Laboratories
13) Prequalification of Active Pharmaceutical Ingredients
14) Regulatory Guidance
15) Nomenclature, Terminology and Databases
16) Miscellaneous
17) Summary and recommendations
Acknowledgements
Annexes 1 - 4

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