WHO Expert Committee on Biological Standardization

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WHO Expert Committee on Biological Standardization

Abbreviations
1. Introduction 1
2. General 3
3. International Recommendations, Guidelines and other matters related to the manufacture, quality control and evaluation of biological substances 29
4. International reference materials – antibiotics 38
5. International reference materials – biotherapeutics other than blood products 39
6. International reference materials – blood products and related substances 44
7. International reference materials – in vitro diagnostics 48
8. International reference materials – vaccines and related substances 68
Annex 1
WHO Recommendations, Guidelines and other documents related to the manufacture, quality control and evaluation of biological substances used in medicine 81
Annex 2
Guidelines on the quality, safety and efficacy of Ebola vaccines 87
Annex 3
Guidelines on procedures and data requirements for changes to approved biotherapeutic products 181
Annex 4
Technical Specifications Series (TSS) for WHO Prequalification – Diagnostic Assessment 281
Annex 5
Technical Guidance Series (TGS) for WHO Prequalification – Diagnostic Assessment 315
Annex 6
Biological substances: WHO International Standards, Reference Reagents and Reference Panels 377