DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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Drug Registration Guidance Document (<strong>DRGD</strong>)Storage ConditionsState the recommended storage conditions (specific temperature eg: 30 o C, humidity,light etc.).Information shall also include storage condition before first opening, after reconstitutionand/or after opening and for all the listed pack types where applicable. Stability data tosupport such storage condition shall be available.Shelf LifeThe shelf life for all the listed pack types shall be supported by stability data.Information shall also include shelf life before first opening, after reconstitution and/orafter opening where applicable. Stability data to support such shelf life shall beavailable.Evidence is required to demonstrate that the product is stable (meets the finishedproduct shelf life specifications throughout its proposed shelf-life).Therapeutic Code (If any)Please select “Health Supplement”SECTION B: PRODUCT FORMULAChange of formulation whether for active ingredient or excipient is not allowedduring product evaluation.Batch Manufacturing FormulaState the batch size and actual batch manufacturing master formula. Data fromvalidation step will be captured in terms of substance name, type (active ingredient orexcipient), function and quantity per unit dose. Other information will need to beentered.An attachment of the Batch Manufacturing Formula documentation must be provided.The documents must be verified by authorized personel.National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 194
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 | 195
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Page 144 and 145: Drug Registration Guidance Document
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Page 220 and 221: ATTACHMENT 1Drug Registration Guida
Page 228 and 229: PART IV: CLINICAL DOCUMENTSDrug Reg
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Page 236 and 237: APPENDIX 5:Drug Registration Guidan
Page 238 and 239: 1. GENERAL INFORMATIONSDrug Registr
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Route of AdministrationTAMC(CFU/g o
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DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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