FDA-API-Inspections-Robert-Horan-PhD

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1、FDAAPIInspectionsFDAAPIInspectionsRobertC.Horan,PhDRobertC.Horan,PhDFDAPharmaceuticalInspectorateFDAPharmaceuticalInspectorateNewYorkDistrictNewYorkDistrictQualitySystemobservationsQualitySystemobservationsFDA483ObservationsforProductQualityFDA483ObservationsforProductQualityReviewsran

2、geReviewsrangefromfrom::¢NoSOPforProductQualityReviewsNoSOPforProductQualityReviews¢NoProductQualityReviewsconductedNoProductQualityReviewsconductedtoto:Variouscomponentsofthereviewsnot:Variouscomponentsofthereviewsnotdone,inadequateinvestigations,nodone,inadequateinvestigations,nocorr

3、ectiveactionsorotherconclusionscorrectiveactionsorotherconclusionsQualitySystemobservationsQualitySystemobservationsRegardingtheannualproductreviews:Regardingtheannualproductreviews:¢ThereportsdonotidentifythespecificbatchesThereportsdonotidentifythespecificbatcheswhichwerecoveredbythe

4、reviewperiodandwhichwerecoveredbythereviewperiodandthereisnoevaluationofspecificdatafromthethereisnoevaluationofspecificdatafromthebatchescovered.batchescovered.¢Theannualreportfrom200XwasfoundtoTheannualreportfrom200Xwasfoundtocontainsomeconclusionsregardingoutofcontainsomeconclusions

5、regardingoutofspecificationdataandcorrectiveactionswithoutspecificationdataandcorrectiveactionswithoutprovidingspecificinformationsuchasbatchprovidingspecificinformationsuchasbatchnumbers,actualevents,specificdata,numbers,actualevents,specificdata,conclusionsandanyspecificcorrectionsma

6、de.conclusionsandanyspecificcorrectionsmade.QualitySystemobservationsQualitySystemobservationsAnexampleisonpage3whichstates:Anexampleisonpage3whichstates:““Themainunqualifieditemin200XistheThemainunqualifieditemin200XistheXXXcontentoutofthespecificrange.WeXXXcontentoutofthespecificrang

7、e.Wetakerelativemeasurestostrengthenthetakerelativemeasurestostrengthenthecontrolofmanufacturingprocess,trainingcontrolofmanufacturingprocess,trainingtheworkers,strengtheningtheworkerstheworkers,strengtheningtheworkers’’qualitysensequalitysense””..QualitySystemobservationsQualitySyst