NE17. dinner seminar on FDA inspections1

《NE17. dinner seminar on FDA inspections1》由会员上传分享，免费在线阅读，更多相关内容在学术论文-天天文库。

1、DrugGoodManufacturingPracticesInspectionsNewEnglandDistrictInvestigationsBranchParenteralDrugAssociationNewEnglandChapterMay17,2006DRUGMANUFACTURINGINSPECTIONSInspectionsInclude:Domestic/ForeignManufacturersRepackersandRelabelersRadiopharmaceuticalsCompressedMedi

2、calGasesActivePharmaceuticalIngredients/ChemicalsRxandOTCProductsSterile/Non-SterileProductsDRUGMANUFACTURINGINSPECTIONSòF/Y-03RiskBasedInspectionalAssignments–HighRiskFirmsòRxDrugManufacturers/RepackersòSterileDrugs–Rxand/ornon-Rx–LowRiskFirmsòNon-RxòMedicalGasò

3、Distributors/WarehouseOperationsApplyingRiskManagementtoDrugQualityRegulationòIdentifyparametersandprocessesthatarecriticalfordrugquality–Whatfactorswilladverselyaffectcriticalparameters/processes,increasingprobabilityorseverityorimpact?–Whatfactorswillpositively

4、affectcriticalparameters/processes,decreasingprobabilityorseverityofimpact?òE.g.,greaterprocessknowledgeandcapabilityApplyingRiskManagementtoDrugQualityRegulation(cont’d)òIdentifyingcriticalprocessesandparameters–Sharingdevelopmentreportinformation?–FailureModesa

5、ndEffectsAnalysis(FMEA)?–HazardAnalysisandCriticalControlPoints(HACCP)?–ProcessAnalyticTechnologies(PAT)?–StatisticalProcessControl(SPC)?ApplyingRiskManagementtoDrugQualityRegulation(cont’d)òFocusregulatoryscrutinyandresourcesongreatestperceivedriskstoquality–red

6、irectscrutiny/resourcesfromtheareaswiththelowestrisktoqualitytohigherriskareasòAdjusttheintensityofregulatoryoversightcommensuratewiththeactualrisktodrugquality–ProvideadditionalincentivestomitigateriskandobtaindecreasedregulatoryscrutinyApplyingRiskManagementtoD

7、rugQualityRegulation(cont’d)UNCERTAINTYòTojustifydecreasedregulatoryscrutinyweneedgreaterunderstandingofthesourcesofrisktoproductqualityandthefactorspredictiveofthatrisk–EnhancedhazardidentificationandriskassessmentcapacityòGreateruncertainlyrequiresgreaterregula

8、toryscrutinyApplyingRiskManagementtoDrugQualityRegulation(cont’d)òBurdenmustrestwithregulatedindustrytodemonstratetoFDAthatreducedregulatoryscrutinyisjustified