FDA 的API现场检查 英文

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1、FDAAPIInspectionsFDAAPIInspectionsRobertC.Horan,PhDRobertC.Horan,PhDFDAPharmaceuticalInspectorateFDAPharmaceuticalInspectorateNewYorkDistrictNewYorkDistrictQualitySystemobservationsQualitySystemobservationsFDA483ObservationsforProductQualityFDA483ObservationsforProductQualityReviewsrangeReviewsran

2、gefromfrom::¢NoSOPforProductQualityReviewsNoSOPforProductQualityReviews¢NoProductQualityReviewsconductedNoProductQualityReviewsconductedtoto::¢variouscomponentsofthereviewsnotdone¢inadequateinvestigations¢nocorrectiveactionsorotherconclusionsQualitySystemobservationsQualitySystemobservationsRegard

3、ingtheannualproductreviews:Regardingtheannualproductreviews:¢ThereportsdonotidentifythespecificbatchesThereportsdonotidentifythespecificbatcheswhichwerecoveredbythereviewperiodandtherewhichwerecoveredbythereviewperiodandthereisnoevaluationofspecificdatafromthebatchesisnoevaluationofspecificdatafro

4、mthebatchescovered.covered.¢Theannualreportfrom200Theannualreportfrom200XwasfoundtocontainXwasfoundtocontainsomeconclusionsregardingoutofspecificationdatasomeconclusionsregardingoutofspecificationdataandcorrectiveactionswithoutprovidingspecificandcorrectiveactionswithoutprovidingspecificinformatio

5、nsuchasbatchnumbers,actualevents,informationsuchasbatchnumbers,actualevents,specificdata,conclusionsandanyspecificspecificdata,conclusionsandanyspecificcorrectionsmade.correctionsmade.QualitySystemobservationsQualitySystemobservationsAnexampleisonpage3whichstates:Anexampleisonpage3whichstates:““Th

6、emainunqualifieditemin200XistheThemainunqualifieditemin200XistheXXXcontentoutofthespecificrange.WeXXXcontentoutofthespecificrange.Wetakerelativemeasurestostrengthenthetakerelativemeasurestostrengthenthecontrolofmanufacturingprocess,trainingcontrolofmanufacturingprocess,trainingtheworkers,strengthe

7、ningtheworkerstheworkers,strengtheningtheworkers’’qualitysensequalitysense””..QualitySystemobservationsQualitySystemobservations¢Manyofthefirm’swrittenprocedures(SOPs)havenotbeenperiodicallyreviewedandrevisedwher