WHO RECOMMENDATIONS FOR THE …

ANNEX 4. WHO RECOMMENDATIONS FOR. THE production , control AND REGULATION OF. HUMAN PLASMA FOR FRACTIONATION. Adopted by the 56th meeting of the WHO Expert Committee on Biological Standardization, 24-28. October 2005. A definitive version of this document, which will differ from this version in editorial but not scientific detail, will be published in the WHO Technical Report Series. Page 2. TABLE OF CONTENTS. Page TABLE OF INTRODUCTION .. 1 INTERNATIONAL BIOLOGICAL REFERENCE PREPARATIONS .. 2 LIST OF ABBREVIATIONS AND DEFINITION USED .. 3 GENERAL Range of products made from human blood and plasma .. Composition of human Pathogens present in blood and 4 MEASURES TO EXCLUDE INFECTIOUS DONATIONS .. Appropriate selection of blood/plasma Screening of blood/plasma donations for infectious markers .. Screening tests .. Other NAT testing .. Test kits .. Quality control of screening .. Look- Epidemiological surveillance of donor population .. Strict adherence to Good Manufacturing Practices.

ANNEX 4 WHO RECOMMENDATIONS FOR THE PRODUCTION, CONTROL AND REGULATION OF HUMAN PLASMA FOR FRACTIONATION Adopted tby the 56 h meeting of the WHO Expert Committee on Biological Standardization, 24-28

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