DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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Drug Registration Guidance Document (<strong>DRGD</strong>)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 | 198
Drug Registration Guidance Document (<strong>DRGD</strong>)Example of In Process Quality Control:Company Name/ Address:Applicant/ Client Name/ Address:Date:In-Process Quality Control: Test performed during manufacturing processNo.Test Done(example)Stage Done(example)Frequencyof testing(example)Quantitysampletaken(example)Specifications(example)Method(example)1. AppearanceBeforeweight, afterencapsulation2 10 gramBlue likeorangeOrganoleptictest2. DisintegrationAftercompression2 10 tabletNMT 30minutesEquipmentetc3.Uniformity ofweightAftertableting,Packaging4 20 Tablets 1 gram/tab4. Microbiology Final Stage 15. Heavy metal Final stage 1* Declaration (if any)Signature (authorized personnel)Name:Designation:* The above parameters are only as an example; other test may be required for specificproduct.National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 199
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DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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