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 APPLIED4. Change in manufacturingprocess of the finishedproductE11P3.2P3.2.1P3.3P3.4P5.1P5.4P8B2.1B2.2B3B4B5F10(CoA offinishedproduct)CONDITIONS1. The same currently approved manufacturing site.2. The change does not cause a negative impact onthe quality, safety and efficacy of the drug product.3. Finished product specification is not adverselyaffected.SUPPORTING DOCUMENTS1. Description of the proposed change inmanufacturing process.2. Comparative batch analysis data between thecurrently approved and proposed manufacturingprocesses OR Certificate of Analysis (CoA), whereapplicable.3. Stability data of drug product (please refer toASEAN Guideline on Stability Study of DrugProduct) where applicable.4. Comparative dissolution profile data between theproducts manufactured in the currently approvedand proposed manufacturing process for oral soliddosage forms as per compendium and validationbatches, where applicable.5. Justification for not submitting a newbioequivalence study according to ASEANGuidelines for the Conduct of Bioavailability andBioequivalence Studies, where applicable.National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 458
Drug Registration Guidance Document (DRGD)NO.VARIATION TYPE II(MAJOR VARIATION)FULLEVALUATIONAFFECTED FIELDSABRIDGEDEVALUATIONSUPPORTING DOCUMENTS REQUIRED ANDCONDITIONS APPLIEDFor abridged-products, only supporting documents(1), (2) and (3) are required.Process validation report may be requested whendeemed necessary.5. Change in overage ofactive ingredientB1.2E11P5.4E12P8B1.2F10F12B5CONDITIONFinished product release and end of shelf lifespecification remains the same.SUPPORTING DOCUMENTS1. Certificate of Analysis (CoA) of drug product.2. Justification for the change.3. Stability data of drug product (please refer toASEAN Guideline on Stability Study of DrugProduct) where applicable.4. Batch manufacturing formula.5. Comparative batch analysis data of drug product.6. Table of comparison of proposed and currentbatch manufacturing formula.7. Letter of commitment to undertake the proposedchange under real time stability study.National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 459
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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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