Forty-ninth report: 897 (Technical report series, 897) - Softcover

WHO Expert Committee On Biological Standardization

Softcover

ISBN 10: 924120897X ISBN 13: 9789241208970

Publisher: World Health Organization, 2001

Synopsis

This report presents the recommendations of a WHO expert committee commissioned to co-ordinate a range of research and other activities needed to assure the purity, potency, safety and stability of biological products used in medicine. Work includes the development and adoption of detailed recommendations for the manufacturing, licensing and control of vaccines and other biologicals. The committee also co-ordinates the establishment of international reference materials for measuring the potency and other characteristics of biological products. These reference materials are used worldwide and play a crucial role in ensuring the comparability of products on a global basis. The report has four parts. The first provides a brief discussion of general concerns being addressed by WHO in efforts to ensure and safety and efficacy of biological medicines. The second offers a brief review of various international guidelines and recommendations relevant to the manufacture and quality control of biologicals, and identifies recommendations in need of revision.

Part Three summarizes activities relating to the status and development of biological reference materials for selected antibodies, antigens and related substances, blood products and related substances, cytokines, and other substances requiring international reference materials. As guidance for national control authorities and manufacturers, the fourth and most extensive part issues detailed recommendations for the production and quality control of "Haemophilus influenzae" type b conjugate vaccines, and provides an addendum to the 1990 requirements for oral poliomyelitis vaccine.

About this edition

• Publisher: World Health Organization
• Publication date: 2001
• ISBN 10: 924120897X
• ISBN 13: 9789241208970
• Binding: Paperback
• Number of pages: 112