Transcription of Annex 4 - WHO
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Annex 4 - WHO
189 Annex 4 Recommendations to assure the quality, safety and efficacy of recombinant hepatitis B vaccinesReplacement of Annex 2 of WHO Technical Report Series, No. 786 and Annex 4 of WHO Technical Report Series, No. 889 Abbreviations 1911. Introduction 1912. General considerations 192 Part A. Manufacturing recommendations Definitions General manufacturing recommendations Control of source materials Fermentation Single harvests Control of aqueous bulk (purified antigen bulk) Final vaccine bulk Filling and containers Control tests on the final vaccine lot Records Retained samples Labelling Distribution and shipping Stability testing, storage and expiry date 207 Part B. Nonclinical evaluation Strategy for cloning and expressing the gene product Characterization of purified HBsAg for new vaccines Animal models Nonclinical safety studies Toxicology studies 210 Part C. Clinical evaluation Consideration for clinical studies Assessment of the immune response Clinical studies Post-marketing studies 215 Part D.
Annex 4 191 Abbreviations anti-HBs antibody to HBsAg CHO Chinese hamster ovary ED 50 median effective dose GMT geometric mean titre ICH International Conference on Harmonisation of Technical
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