Transcription of Annex 4 - WHO
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Annex 4 - WHO
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 monovalent virus pools Control of final bulk Filling and containers Control tests on final product Identity Sterility Infectivity (potency) Endotoxin Residual moisture of lyophilized vaccines Inspection of final containers Records Retained samples Labelling Distribution a
154 WHO Technical Report Series No. 977, 2013 WHO Expert Committee on Biological Standardization Sixtieth report A.12 Stability 193 A.12.1 Stability testing 193 A.12.2 Storage conditions 194 A.12.3 Expiry date 194 Part B. Nonclinical evaluation of new influenza vaccines
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