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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)

• EU and PIC GMP guidelines: “Formally authorised Manufacturing Formula and Processing Instructions should exist for each product and batch size to be manufactured. They are often combined in one document.” • Health Canada GMP guidelines. MASTER FORMULA (formule-type) …

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