Transcription of guide to master formulae final - WHO
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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. 5 to show the separate fills. Similarly, a large fill lot with a unique lot number may be lyophilized in different lyophilizers and the suffix would indicate the different freeze-
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