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 APPLIED9. Change in particular ofmanufacturer of drugsubstance (activeingredient ) without anychange in specificationa. Change inmanufacturer of drugsubstanceS2.1S4.4F11CONDITIONS1. Finished product release and end of shelf lifespecification remains the same.2. Method of preparation and route of synthesisremain the same.3. For (c), the manufacturing site of the drugsubstance remains the same.SUPPORTING DOCUMENTSb. Addition ofmanufacturer of drugsubstancec. Change in name and/orrephrasing of addressof a manufacturer ofdrug substance.For (a) & (b):1. Certificate of Analysis (CoA) for drug substance(Also include CoA from all of the drug substancemanufacturers proposed to be retained) or batchanalysis of drug substance.2. Certificate of Suitability (CEP) for the drugsubstance or Drug Master File; or reference toDMF by USFDA, TGA or JFDA (if applicable).3. Tabulation of the differences compared with theregistered manufacture information (if applicable).For (c):1. Updated information of the manufacturer of thedrug substance.2. Official document/ evidence when required.National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 462
Drug Registration Guidance Document (DRGD)NO.VARIATION TYPE I(MINOR VARIATION)FULLEVALUATIONAFFECTED FIELDSABRIDGEDEVALUATIONSUPPORTING DOCUMENTS REQUIRED ANDCONDITIONS APPLIED10. Change in secondarypackaging material (orchange in any part of theprimary packagingmaterial that is not incontact with the finishedproduct (e.g. colour of flipoff caps, colour code ringson ampoules, change ofneedle shields i.e.different plastic used).CD2D3P7CD2D3CONDITIONS1. The primary packaging material of container orclosure remains the same.2. The change does not affect the delivery, use,safety or stability of the finished productSUPPORTING DOCUMENTRevised drafts of the package insert and labelingincorporating the proposed variation (whereapplicable).11. Change in testingprocedure of an excipientP4.2P4.3Not applicableCONDITIONSpecifications of the excipient and drug product(finished product) remain the same.National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 463
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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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