Master Formula Record (MFR) for a new product from Formulation Development or Technical Services- Bill of Material (BOM): A list of actives, excipients, and primary packing materials used to manufacture a particular product along with the Batch size, quantity required for the batch and MOC of Consumables. Process Instruction: A list of ingredients used to manufacture a dosage form along with the manufacturing procedure, hold time recommendation and schematic representation. CREATION OF MASTER FORMULA RECORD The Master Formula Record shall consist of two parts- § Part One: Bill of Materials (BOM) § Part Two: Process Instruction (PI) Ø MFR= BOM + PI BOM consists of Finished Product Information, Bill of Materials, Potency calculation with molecular weight details, Raw material & Primary Packing material information and Stock solution preparation and Process Aids (Materials of Construction (MOC) of Filters & Tubing’s without item ...