FDA化验室OOS指南中英文_Guidance_for_Industry_OOS_CHEN

ContainsNonbindingRecommendationsGuidanceforIndustryInvestigatingOut-of-Specification(OOS)TestResultsforPharmaceuticalProductionU.S.DepartmentofHealthandHumanServicesFoodandDrugAdministrationCenterforDrugEvaluationandResearch(CDER)October2006PharmaceuticalCGMPsContainsNonbindingRecommendationsContainsNonbindingRecommendationsGuidanceforIndustryInvestigatingOut-of-Specification(OOS)TestResultsforPharmaceuticalProductionAdditionalcopiesareavailablefrom:本文件可自以下途径得到OfficeofTrainingandCommunication培训和交流办公室DivisionofDrugInformationHFD-240药品信息分部CenterforDrugEvaluationandResearch药品审评中心FoodandDrugAdministration食品药品管理局5600FishersLaneRockville,MD20857(Tel)301-827-4573美国卫生和福利部FoodandDrugAdministration食品药品管理局CenterforDrugEvaluationandResearch(CDER)药品审评中心October2006PharmaceuticalCGMPsContainsNonbindingRecommendationsContainsNonbindingRecommendationsTABLEOFCONTENTSInvestigatingOut-of-Specification(OOS)TestResultsforPharmaceuticalProduction..........................4I.INTRODUCTION介绍.................................................................................................................4II.BACKGROUND背景.................................................................................................................5III.IDENTIFYINGANDASSESSINGOOSTESTRESULTS界定和评价OOS检验结果—PHASEI:LABORATORYINVESTIGATION第一步：化验室调查...................................................................6A.ResponsibilityoftheAnalyst化验员职责............................................................................7B.ResponsibilitiesoftheLaboratorySupervisor化验室主管职责............................................8IV.INVESTIGATINGOOSTESTRESULTS对OOS结果的调查—PHASEII:FULL-SCALEOOSINVESTIGATION第二步：全面OOS调查....................................................................................10A.ReviewofProduction生产情况审核.................................................................................10B.AdditionalLaboratoryTesting附加化验室测试..................................................................11C.ReportingTestingResults报告测试结果..........................................................................14V.CONCLUDINGTHEINVESTIGATION调查结论.....................................................................17A.InterpretationofInvestigationResults调查结果解释........................................................18B.Cautions注意事项............................................................................................................19C.FieldAlertReports.............................................................................................................20ContainsNonbindingRecommendationsGUIDANCEFORINDUSTRY1行业指南InvestigatingOut-of-Specification(OOS)TestResultsforPharmaceuticalProduction药物生产中不合格结果的调查ThisguidancerepresentstheFoodandDrugAdministration's(FDA's)currentthinkingonthistopic.ItdoesnotcreateorconferanyrightsfororonanypersonanddoesnotoperatetobindFDAorthepublic.Youcanuseanalternativeapproachiftheapproachsatisfiestherequirementsoftheapplicablestatutesandregulations.Ifyouwanttodiscussanalternativeapproach,contacttheFDAstaffresponsibleforimplementingthisguidance.IfyoucannotidentifytheappropriateFDAstaff,calltheappropriatenumberlistedonthetitlepageofthisguidance.本指南代表FDA对本专题现行的想法。它没有给任何人创造或者赋予他们任何的权利，而且也不会束缚FDA或公众的操作。如果有替代的方法能满足法律法规的要求，你可以使用一个替代的方法。如果你要讨论一个替代的方法，请联系负责实施本指南的FDA工作人员。如果你不能够识别适当的FDA工作人员，请拨打本指南封面页上的适当电话。I.INTRODUCTION介绍ThisguidanceforindustryprovidestheAgency’scurrentthinkingonhowtoevaluateout-of-specification(OOS)testresults.Forpurposesofthisdocument,thetermOOSresultsincludesalltestresultsthatfalloutsidethespecificationsoracceptancecriteriaestablishedindrugapplications,drugmasterfiles(DMFs),officialcompendia,orbythemanufacturer.Thetermalsoappliestoallin-processlaboratoryteststhatareoutsideofestablishedspecifications.2本指南旨在表达当局对如何评价OOS结果的昀新想法。本文件中OOS结果这个术语包括所有不符合质量标准，或经由药品申请、DMF文件、官方药典及生产商所确立的可接受标准的检测结果。这个术语也适用于所有不符合已建立标准的中控化验室检测结果。Thisguidanceappliestochemistry-basedlaboratorytestingofdrugsregulatedbyCDER.Itisdirectedtowardtraditionaldrugtestingandreleasemethods.Theselaboratorytestsareperformedonactivepharmaceuticalingredients,excipientsandothercomponents,in-processmaterials,andfinisheddrugproducts3totheextentthatcurrentgoodmanufacturingpractice(CGMP)regulations(21CFRparts210and211)andtheFederalFood,1ThisguidancehasbeenpreparedbytheOfficeofCompliance/DivisionofManufacturingandProductQualityintheCenterforDrugEvaluationandResearch(CDER).本指南由药品评审中心CDER生产和产品质量分部法规符合办公室起草。2Incertaininstances,in-processtestingisdonesolelyforpurposesoftriggeringrealtimeequipmentorsystemadjustmentstopreventprocessdrift.Thisguidancedoesnotaddressthesesituations.在特定情况下，中控检测的目的仅仅是触发实时设备和体系调节以防止工艺偏差。本指南不适用于这种情况。3Chemistry-basedlaboratorytestingofbiotechnologyproductsthatareunderthejurisdictionofCDERarewithinthescopeofthisguidance.However,thisguidanceisnotintendedtoaddressbiologicalassays(e.g.,invivo,immunoassays).由CDER负责的生物技术产品的化学检测项目在本指南范围内。但本指南不适用于生物含量检测（例如体内免疫检测）。ContainsNonbindingRecommendationsDrug