Transcription of Annex 5 - WHO
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Annex 5 - WHO
271 Annex 5 Recommendations to assure the quality, safety and efficacy of tetanus vaccines (adsorbed)Replacement of Annex 2 of WHO Technical Report Series, No. 800, and Annex 5 of WHO Technical Report Series, No. 927 Introduction 273 Scope of the Recommendations 279 General considerations 279 Part A. Manufacturing recommendations Definitions General manufacturing recommendations Production, processing and control Filling and containers Control of final product Records Retained samples Labelling Distribution and transport Stability, storage and expiry date 300 Part B. Nonclinical evaluation of tetanus vaccines Introduction Nonclinical testing and characterization of intermediates and in-process materials Nonclinical characterization of formulated vaccine 305 Part C.
274 WHO Technical Report Series No. 980, 2014 WHO Expert Committee on Biological Standardization Sixty-third report delivering the vaccine without needles (8) and improving the formulation and stability to eliminate the need for cold-chain storage.
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