MFR

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 codes). Under the control of R&D. Upon approval of the MFR-BOM, the same shall be distributed to the specific manufacturing sites as requested.

Process Instruction which shall be referred to as PI, consists of Product specific requirements, Precautions, Critical Process Parameters (CPPs), Area requirements, Recommended equipment, accessories & utilities, Detailed manufacturing

instructions, Hold time & Contact time recommendations and a Schematic representation. MFR– Process Instruction shall be distributed to the specific manufacturing sites as per the document request.

Expiry date of the Product to be fixed based on the Shelf life of the product or API expiry date, whichever is earlier.

PART ONE: FINISHED PRODUCT INFORMATION AND BILL OF MATERIALS

FINISHED PRODUCT INFORMATION: Product Information sheet shall contain details such as product description, Pharmacopoeial reference, Label claim / composition & strength, Storage condition, Primary Packaging details, Exhibit Batch size, OEB Class, Remarks and Reference MFR number.

MASTER FORMULA RECORD – PROCESS INSTRUCTION

Master Formula Record-Process instruction consists of Product specific requirements, Precautions, Critical Process Parameters (CPPs), Area requirements, Recommended equipment, accessories & utilities, detailed manufacturing procedure, Hold time & Contact time recommendations and a Schematic representation.