美国ICPE规定的主药和辅料的管理——David-R.-Schoneker-豆柴文库

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IPECActivitiesandExcipientRegulationintheUnitedStatesOutlineWhatisIPEC?WhatisIPEC?Colorcon’sInvolvementwithIPECIPECMissionBuildingBridgeswithRegulatorsExcipientGMPsintheU.S.ExcipientGMPsintheU.S.IPECExcipientGMP’sIPECExcipientGMP’sPublishedIPEC-AmericasGuidelinesIPECInitiativesIPECInitiativesCurrentIPEAAuditReportsUseofExcipientsinNDA’sintheU.S.UseofExcipientsinNDA’sintheU.S.U.S.GenericApplicationsFDA’sInactiveIngredientDatabaseisavailableon-line:

http://www.accessdata.fda.gov/scripts/cder/iig/index.cfm

Databasehascertainlimitations:
Insomecases,aquantitativelimitisnotshowninthepublicversionduetoconfidentiality
Oftenliststhesameexcipientbydifferentnamesandsometimesusestradenames(multiplelistingspossiblewithdifferentlevels)
Theexactnameusedinthedatabasemustbeknowntosearch;acomprehensivelistcannotberetrieved
DatabaseisonlyupdatedquarterlyGlobalCOLORANTRegulationsForPharmaceuticalsOneColorForTheWorld:GlobalFormulationProblemsKeyColorsUsedInGlobalPharmaceuticalsDesiredGlobalColorRegulationsDrugMasterFilesUSDMFFacts(J.Clark,FDA,2003)USDMFFilings,2002(J.Clark,FDA,2003)DrugMasterFileRequirementsTypeIVDMFInformationRequirementsIPECProposals:Global“ExcipientMasterFiles”ExcipientMasterFiles:ConsistentwithCTDSubmissionsExcipientMasterFileComponentsEMFOrganizationTheIncreasingVisibilityofExcipientsQualificationofExcipientSuppliersSupplierQualificationIPECExcipientQualificationGuidelineExcipientQualificationGuideline©Copyright–IPECAmericasExcipientQualificationProcess-User©Copyright–IPECAmericasPharmacopeialHarmonizationHarmonizationofExcipientStandardsToday’sHarmonizationOutcomesChinesePharmacopeiaProductFilingInformationPre-MixedExcipientsProductFilingInformationPre-mixedExcipientsDrugMasterFilesPre-mixedExcipientsPost-ApprovalChangesUnitedStatesTheSUPACGuidanceDefines:MajorImplicationsofSUPACIRQualityandPerformanceExcipientManufactureIPEC-SignificantChangeDefinedSignificantChangeExcipientManufacturingChangestoConsiderCriteriaforJudgingSignificanceLevelsofChange-SUPACTypeCon