DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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Drug Registration Guidance Document (<strong>DRGD</strong>)No.FieldGeneral orNutritionalClaimsFunctionalClaimsManufacturing process validation report ifapplicableLetter of commitment if applicableEtc.* Complete stability study conducted at 30 ± 2 ºC / RH 75 ± 5%, IPQC, FPQC, protocol analysisand COA of finished product are required to be submitted 2 years after product registration withSAMPLE of the products. Failure on submission will cause the product be suspended until thecomplete documents are submitted, the registration of the product will be terminated if thecomplete documents still cannot be produced upon renewal of product registration.National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 224
Drug Registration Guidance Document (<strong>DRGD</strong>)Dossier Requirement for Disease risk reduction as in Table 16 above andTable 17 below:Table 17: Additional Quality Data Checklist for Disease Risk Reduction ClaimNo. Field Disease Risk Reduction ClaimPARTPP. HEALTH SUPPLEMENT PRODUCTP1. Description and CompositionP2. Pharmaceutical DevelopmentP2.1 Information on DevelopmentStudiesP2.2 Components of the HealthSupplement ProductP2.3 Finished ProductP2.4 Manufacturing ProcessDevelopmentP2.5 Container Closure SystemP2.6 Microbiological AttributesP2.7 CompatibilityP3. ManufacturerP3.1 Batch Manufacturing FormulaP3.2 Manufacturing Process &Process ControlP3.2.1 Manufacturing ProcessFlowchartP3.3 Control of Critical Steps &IntermediatesP3.4 Process Validation andEvaluationP4. Control of ExcipientsP4.1 SpecificationsP4.2 Analytical ProcedureP4.3 Validation of AnalyticalProceduresP4.4 Justification of SpecificationP4.5 Excipient of Human or AnimalOriginP4.6 Novel ExcipientsP5. Control of Finished ProductP5.1 SpecificationP5.2 AnalyticalProceduresP5.3 Validation of Analytical√National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 225
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Page 174 and 175: Drug Registration Guidance Document
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Page 220 and 221: ATTACHMENT 1Drug Registration Guida
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Page 238 and 239: 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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