DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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Drug Registration Guidance Document (DRGD)NO.VARIATION TYPE II(MAJOR VARIATION)FULLEVALUATIONAFFECTED FIELDSABRIDGEDEVALUATIONSUPPORTING DOCUMENTS REQUIRED ANDCONDITIONS APPLIED11. Change or addition inprimary packagingmaterialCD1D2D3P3.2P3.2.1P7P8E8(if applicable),E12CD1D2D3(if applicable),B5,F8(if applicable)F12CONDITIONSRelease and shelf life specification remainsthe same.SUPPORTING DOCUMENTS1. Assembly process for the new packaging material/revised manufacturing process and revised flowchart (if any)2. Stability data of drug product (please refer toASEAN Guideline on Stability Study of DrugProduct) where applicable.3. Revised drafts of the package insert and labelingincorporating the proposed variation (whereapplicable).4. Justification for the change in packaging materialand appropriate scientific studies on the newpackaging.5. For semisolid and liquid dosage forms, proof mustbe provided that no interaction between thecontent and the packaging material occurs.(e.g. no migration of components of the proposedmaterial into the content and no loss ofcomponents of the product into the pack).6. Container closure system (if applicable).National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 472
Drug Registration Guidance Document (DRGD)NO.VARIATION TYPE II(MAJOR VARIATION)FULLEVALUATIONAFFECTED FIELDSABRIDGEDEVALUATIONSUPPORTING DOCUMENTS REQUIRED ANDCONDITIONS APPLIED12. Change in shelf life offinished product:-a) As packaged for saleb) After first openingA16P8E12D1D2D3A13B5F12D1D2D3CONDITIONS1. For (a) & (b) - The studies must showconformance to the current shelf life specification.2. For (c) - Studies must show conformance to thecurrent shelf life specification for the reconstitutedproduct.c) After dilution/reconstitutionSUPPORTING DOCUMENTS1. Results of appropriate real time stability studiescovering the duration of proposed shelf-life of atleast 2 pilot/ production scale batches of theproduct in the authorized packaging materialas a package for sale and/orafter first opening and/orafter the dilution/ reconstitutionIn accordance with the ASEAN Guidelines on StabilityStudy of Drug Product; results of appropriatemicrobiological testing should be included (whereappropriate).2. Revised drafts of the package insert and labelingincorporating the proposed variation (whereapplicable).3. Justification letter for the change of shelf life of thedrug product (if applicable).National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 473
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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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e) Example of label approved by the
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DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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