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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) Issuing of MF copy as a blank batch record 11 10)

Draft: Guide to Master Formulae. 6 6) Required Contents of a MF Each of the regulation or guidelines above give a list of the requirements for the contents

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