DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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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 | 228
Drug Registration Guidance Document (<strong>DRGD</strong>)No. Field Disease Risk Reduction ClaimProceduresP5.4 Batch AnalysesP5.5 Characterization of impuritiesP5.6 Justification of SpecificationP6. Reference Standards or MaterialsP7. Container Closure SystemP8. StabilityP9. Product Interchangeability/EquivalentevidencePARTSS. HEALTH SUPPLEMENTSUBSTANCES1. General InformationS1.1 NomenclatureS1.2 StructureS1.3 General PropertiesS2. ManufactureS3. CharacterisationS4. Control of Health SupplementSubstanceS4.1 SpecificationS4.2 Analytical ProceduresS4.3 Validation of AnalyticalProcedureS4.4 Batch AnalysisS4.5 Justification of SpecificationS5. Reference Standards or MaterialsS6. Container Closure SystemS7. Stability√National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 229
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DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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