DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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Drug Registration Guidance Document (<strong>DRGD</strong>)3. THE FINAL PRODUCT• Finished product testing and quality control• Stability study program and expiration date• Product history• Container closure system, storage and handling• Package insert and labels• Lot/ batch release protocols• Certificate of batch review and release from a competent authority4. CLINICAL STUDIES• Demonstrating product‟s efficacy5. POST MARKETING SURVEILLANCE – mandatory follow-up• Periodic Safety Update Report (PSUR)• Risk Management PlansNational Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 162
Drug Registration Guidance Document (<strong>DRGD</strong>)c) Checklist of Plasma Master File for Blood ProductsSection Documents Yes/No1. General Information1.1 Plasma Derived Products‟ List1.21.3Overall Safety StrategyCollection of plasmaTestingStorageGeneral LogisticsFlowchart of supply chain of plasma2. Technical Information on Starting Materials/Plasma2.1Plasma OriginInformation on Collection CentersInformation on Testing CentersSelection/ Exclusion Criteria for DonorsTraceability2.22.3Plasma Quality and SafetyCompliance with Ph. Eur. Monographs or relevantmonographsScreening Tests for Markers of InfectionTechnical Characteristics of Bags and Bottles for Bloodand Plasma Collection, Including Information onAnticoagulant Solutions UsedStorage and TransportProcedures for any Inventory Hold PeriodCharacterisation of the Fractionation PoolContract Between Manufacturer and Blood CollectionEstablishment(s)System in place between the manufacturer and/orplasma fractionators/ processor on one hand, and bloodcollection establishments on the other hand whichdefines the conditions of their interaction and theiragreed specificationsNational Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 163
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ATTACHMENT 1Drug Registration Guida
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PART IV: CLINICAL DOCUMENTSDrug Reg
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ATTACHMENT 2Drug Registration Guida
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APPENDIX 5:Drug Registration Guidan
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1. GENERAL INFORMATIONSDrug Registr
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Route of AdministrationTAMC(CFU/g o
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d) Example of label approved by the
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DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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