Transcription of Annex 4 - WHO | World Health Organization
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Annex 4 - WHO | World Health Organization
153 Annex 4 Recommendations to assure the quality, safety and efficacy of influenza vaccines (human, live attenuated) for intranasal administrationIntroduction 156 General considerations 156 Part A. Manufacturing recommendations Definitions International name and proper name Descriptive definition International standards Terminology Background on influenza vaccine (human, live attenuated) production General manufacturing recommendations Procedures and facilities Eggs and cell cultures Control of source materials Choice of vaccine strain Substrate for virus propagation Master cell bank and manufacturer's working cell bank Cell culture medium Virus strains Control of vaccine production Production precautions Production of monovalent virus pool Control of mo
Annex 4 155 Appendix 2 Reference laboratories 224 Appendix 3 Model certificate for the release of influenza vaccine (human, live attenuated) for intranasal administration 226 Recommendations published by WHO are intended to be scientific
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