DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

Drug Registration Guidance Document (DRGD)Example of BMF documentation:ABC Sdn. BHD.Batch Manufacturing FormulaProduct Name:Batch Quantity: 1,000,000 capsulesNameFunctionQuantityper capsuleBatchquantityOveragePyridoxine HCl Active _ mg _ kg _ %Cholecalciferol Active _ mg _ kg _ %Glycerin Excipient _ mg _ kg NoneGelatin Excipient _ mg _ kg NonePurified water Excipient 0 mg * _ kg NoneTotal: _ mg* evaporated, does not exist in final formulation(Signature)Post of authorized personName of authorized personDate:Total: _ kgManufacturing processState a brief description of the manufacturing process. Essential points of each stage ofmanufacturing process and a description of the assembling of the product into finalcontainers shall be covered. If the product is repacked/assembled by anothermanufacturer, details of repacking/assembly and quality control must be supplied.An attachment of the manufacturing process, in the form of a flow chart can be made.In Process Quality Control (IPQC)To provide a summary of the tests performed, stages at which they are done, and thefrequency of sampling and number of samples taken each time. Specifications forquality assurance of the product shall be supplied.National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 195