Transcription of Guide to Master Formulae Final - WHO
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Guide to Master Formulae Final - WHO
draft : Guide to Master Formulae . 1 Guide TO Master Formulae Table of Contents: page 1) Introduction 3 2) Terms for Master Formula (MF) 3 3) Definitions of Batch / Lot 4 4) Master Formulae needed 4 5) GMP guidelines on Master documentation 5 6) Required Contents of a MF 6 7) MF and corresponding Batch Records 10 8) Formats for MF 10 9)
Draft: 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 signature, handwritten) by one person and
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