预览加载中,请您耐心等待几秒...
1/10
2/10
3/10
4/10
5/10
6/10
7/10
8/10
9/10
10/10

亲,该文档总共60页,到这已经超出免费预览范围,如果喜欢就直接下载吧~

如果您无法下载资料,请参考说明:

1、部分资料下载需要金币,请确保您的账户上有足够的金币

2、已购买过的文档,再次下载不重复扣费

3、资料包下载后请先用软件解压,在使用对应软件打开

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