guide to master formulae final 2012 - WHO

guide to master formulae WHO/FWC/IVB/QSS/VQR. 2011. guide to master formulae Guidance Document This guidance document guide TO master formulae is one of a series developed by WHO/FWC/IVB Quality, Safety & Standards team upon request from the manufacturers' members of the Developing Countries Vaccine Manufacturers Network (DCVMN), with funds of USAID. A set of priority topics have been identified by the manufacturers for WHO to provide guidance on expectations from the vaccine prequalification programme. The guidance document guide TO master formulae is targeted primarily at manufacturers who are new to the prequalification of vaccines and who require detailed guidance about the level of detail needed for the development of batch production records. It may also be a useful guide to National Regulatory Authorities (NRAs) in vaccine producing countries. These are not official WHO documents but rather notes for guidance on expected standards to be followed for the prequalification of vaccines.

Guide to Master Formulae Guidance Document 3 Appendix 5: Extracts from US Code of Federal Regulations (CFR) and US FDA Guidelines. App 5-1) US Regulations for Master Production Records for Finished Pharmaceuticals.

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