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)
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 of the MF. These are given in Table A for the Master (Production) Formula and Table B for the Master Packaging Formula for WHO, EU, PICs and Health Canada. Table C gives
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