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 APPLIEDcurrent manufacturing formula.2. New batch manufacturing formula.3. Batch analysis data (in a comparative table).4. Certificate of analysis for 2 batches of drugproduct.5. Process validation report (may be requested whendeemed necessary).6. Justification for the change.7. Letter of commitment to undertake the proposedbatch size under real time stability studies.8. Description of the manufacturing process (ifapplicable).8. Change in hard capsuleshell (colour, size orsource)A4P1P8E11P4.5P5.4E12P5.1E9D1D2D3(if applicable)A2A3.2B4B5F9F10D1D2D3(if applicable)CONDITIONS1. Includes change of hard gelatin capsule tovegetable capsule but does not apply change fromhard gelatin capsule to soft gel capsule.2. Any new coloring agent used must be of oralpharmaceutical/ food grade and not a listedbanned substance.3. Same functional characteristics, no change indissolution profile for solid dosage forms4. Finished product release and shelf lifespecifications remain the same except for theproduct description.SUPPORTING DOCUMENTS1. Stability data of drug product (please refer toNational Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 468
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 | 469
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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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