DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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Drug Registration Guidance Document (DRGD)NO.VARIATION TYPE I(MINOR VARIATION)FULLEVALUATIONAFFECTED FIELDSABRIDGEDEVALUATIONSUPPORTING DOCUMENTS REQUIRED ANDCONDITIONS APPLIED6. Change in shape ordimensions of thecontainer or closurewithout any otherchanges.P7C (if applicable)C (if applicable)CONDITIONS1. The primary packaging material of container orclosure remains the same.2. Not applicable for sterile products.3. No change is made to the product shelf life and/orstorage conditions.4. No change in the qualitative or quantitativecomposition of the container and/or closure and thechange do not affect the delivery, use, safety orstability of the drug product.SUPPORTING DOCUMENTSRevised drafts of the package insert and labelingincorporating the proposed variation (whereapplicable).7. Change in pack size ofthe drug product(Finished product),without change inprimary packagingmaterial.Change in the numberor units (e.g. tablets,ampoules) in a pack.CD1D2D3E8(if applicable)P7CD1D2D3F8(if applicable)CONDITIONS1. The primary packaging material of container orclosure remains the same. Primary packagingmaterial is the material that is in contact with thefinished product and may affect the delivery, use,safety or stability.2. No other changes to the label/ package insertexcept for the pack size.3. The new size is consistent with the dosageregimen and duration of use as approved in theNational Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 460
Drug Registration Guidance Document (DRGD)NO.VARIATION TYPE I(MINOR VARIATION)FULLEVALUATIONAFFECTED FIELDSABRIDGEDEVALUATIONSUPPORTING DOCUMENTS REQUIRED ANDCONDITIONS APPLIEDpackage insert.Change in volume ofnon sterilepreparationsSUPPORTING DOCUMENTSRevised drafts of the package insert and labelingincorporating the proposed variation (whereapplicable).8. Tightening of specificationlimits of drug product(finished product ) and/ordrug substance (activeingredient )E9E10E11P5.1P5.2P5.4S4.1S4.2S 4.4B4F9F10(finished product)F11(active ingredient)CONDITION1. Any change should be within the range of currentlyapproved limits.SUPPORTING DOCUMENTS1. Tabulation of the current and revised release andshelf life specifications of the drug product/drugsubstance with changes highlighted.2. Certificate of Analysis (CoA) for drug product ordrug substance.3. Protocol analysis for drug product/ drug substance.4. Revised specification of drug substance.5. Specifications of drug product.6. Batch analysis of drug product.National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 461
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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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