Transcription of Annex 3 - WHO
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Annex 3 - WHO
137 Introduction 139 General considerations 139 Special considerations 140 Scope of the Recommendations 141 BCG vaccine strains 141 Potency-related tests 142 Part A. Manufacturing recommendations Definitions General manufacturing recommendations Control of source materials Control of vaccine production Filling and containers Control tests on final lot Records Retained samples Labelling Distribution and transport Stability, storage and expiry date 157 Part B. Nonclinical evaluation of BCG vaccines 159 Part C. Clinical evaluation of BCG vaccines General considerations Special considerations Post-marketing surveillance 164 Part D.
Annex 3 141 Scope of the Recommendations These revised Recommendations refer to freeze-dried BCG vaccines prepared from substrains derived from original BCG for use in the prevention of TB.
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