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 APPLIED10. Change to in-processtests or limits appliedduring manufacture of theproduct.P3.3P3.4E9E10B3F9CONDITIONS1. Includes tightening of in-process limits andaddition of new tests2. Release and shelf-life specifications of drugproduct remain unchangedSUPPORTING DOCUMENTS1. A description of the analytical methodology andsummary of validation data must be provided forall new analytical methods (where applicable).2. Revised in-process specifications together withjustification and relevant process validation data.National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 474
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 | 475
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PART III: NON-CLINICAL DATADrug Reg
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- All information must be provided
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1.2 EXEMPTION FROM PRODUCT REGISTRA
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For product containing Red Yeast Ri
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DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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