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 APPLIEDASEAN Guideline on Stability Study of DrugProduct) where applicable.2. Certificate of analysis (CoA) of drug product withthe new description.3. For empty hard capsule made of ruminantssource, Transmitting Animal SpongiformEncephalopathy (TSE)-free certificate issued fromrelevant veterinary authority of the issuing country.4. Certificate of analysis of the new capsule shell.5. Revised specifications of drug product.6. Batch analysis data.7. Comparative dissolution profile data of drugproduct.8. Revised drafts of the package insert and labelingincorporating the proposed variation (whereapplicable).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 APPLIED9. Change in finishedproduct or activeingredient specification(includes addition of anew test parameter)E9E10E11P5.1P5.4P5.6S4.1S4.2S4.3S4.4B4F9F10F11CONDITIONSThe change should not be the result of unexpectedevents arising during manufacture or because ofstability concerns.SUPPORTING DOCUMENTS1. For change in finished product specifications:a. Certificate of analysis of drug product as perthe new specifications:b. Comparative table of approved and proposedspecifications with justificationc. Appropriate analytical validation datad. Revised specifications of drug product.e. Revised analytical procedures.f. Batch analysis data of drug product.2. For change in active ingredient/ drug substancespecifications:a. Comparative table of approved and proposedspecifications with justificationb. Specification of drug substance,c. Analytical procedures of drug substance,d. Validation of analytical procedures,e. Batch analysis of drug substanceNational Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 473
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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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