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Search results with tag "Guide to master formulae"
guide to master formulae final - WHO | World …
www.who.intDraft: Guide to Master Formulae. 4 • US CFR. To assure uniformity from batch to batch, master production and control records for each drug product, including each batch size thereof, shall be prepared, dated, and signed (full …
guide to master formulae final 2012 - WHO
www.who.intGuide 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.