Transcription of Annex 2 - WHO
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Annex 2 - WHO
49 Annex 2 Recommendations to assure the quality, safety and efficacy of poliomyelitis vaccines (oral, live, attenuated)Replacement of Annex 1 of WHO Technical Report Series, No. 904, and Addendum to Annex 1 of WHO Technical Report Series, No. 910 Introduction 51 General considerations 52 Scope of the Recommendations 58 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 80 Part B. Nonclinical evaluation of poliomyelitis vaccines (oral, live, attenuated) Characterization of a new virus submaster seed from the WHO master seed Characterization of virus working seeds from an established master seed where passage level between master seed and working seed is increased Characterization following changes in the manufacturing process 82 Part C.
Annex 2 51 Introduction WHO Requirements for oral poliomyelitis vaccine (OPV) were first formulated in 1962 (1), and revised in 1965 (2), and then again in 1971 (3), when an appendix describing the production of OPV in human diploid cells was added.
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