第1页共16页编号：时间：2021年x月x日书山有路勤为径，学海无涯苦作舟页码：第1页共16页GuidanceforIndustry，InvestigatingOutofSpecification(OOS)TestResultsforPharmaceuticalProduction行业指南：药品检验结果OOS的调查DRAFTGUIDANCE指南草案U.S.DepartmentofHealthandHumanServicesFoodandDrugAdministrationCenterforDrugEvaluationandResearch(CDER)September1998CP#第2页共16页第1页共16页编号：时间：2021年x月x日书山有路勤为径，学海无涯苦作舟页码：第2页共16页TABLEOFCONTENTS目录I.INTRODUCTION序言...........................................................1II.BACKGROUND.背景...........................................................1III.IDENTIFYINGANDASSESSINGOOSTESTRESULTSOOS检验结果的判断和评估....2A.ResponsibilityoftheAnalyst检验员的责任.........................................2B.ResponsibilitiesoftheSupervisor主管的责任...........................................3IV.INVESTIGATINGOOSTESTRESULTSOOS检验结果的调查.....................5A.GeneralInvestigationalPrinciples..一般调查原则..................................5B.LaboratoryPhaseofanInvestigation.实验室的调查阶段................................6V.CONCLUDINGTHEINVESTIGATION..调查结论...................................10A.InterpretationofInvestigationResults.调查结果的解释................................10B.Reporting...报告................................................................11ThisguidancehasbeenpreparedbytheOfficeofCompliance/DivisionofManufacturingandProductQuality,CenterforDrugEvaluationandResearch(CDER)attheFoodandDrugAdministration.ThisguidancedocumentrepresentstheAgency’scurrentthinkingonevaluatingOOStestresults.ItdoesnotcreateorconferanyrightsfororonanypersonanddoesnotoperatetobindFDAorthepublic.Analternativeapproachmaybeusedifsuchapproachsatisfiestherequirementsoftheapplicablestatute,regulations,orboth.本指南由FDA的CDER的达标办公室/制造、产品、质量分部起草，本指南阐明了机构关于评估OOS检验结果的现行的想法。它不会创造或赠与任何人任何权力，也不会约束FDA或公众。如果其他可选择的相接近的指南能满足适用的法令和法规的要求，也可以使用。第3页共16页第2页共16页编号：时间：2021年x月x日书山有路勤为径，学海无涯苦作舟页码：第3页共16页GUIDANCEFORINDUSTRY1InvestigatingOutofSpecification(OOS)TestResultsforPharmaceuticalProduction行业指南：药品检验结果OOS的调查I.INTRODUCTION序言ThisguidanceforindustryprovidestheAgency’scurrentthinkingonhowtoevaluatesuspect,oroutofspecification(OOS),testresults.Forpurposesofthisdocument,thetermOOSresultsincludesallsuspectresultsthatfalloutsidethespecificationsoracceptancecriteriaestablishedinnewdrugapplications,officialcompendia,orbythemanufacturer.本行业指南反应了FDA关于如何评估怀疑的或OOS检验结果的现行想法，本指南的目的，OOS结果包括超出了新药申请材料、法定标准、生产商建立的可接受标准或规格的所有可疑的结果。Thisguidanceappliestolaboratorytestingduringthemanufactureofactivepharmaceuticalingredients,excipients,andothercomponentsandthetestingoffinishedproductstotheextentthatcurrentgoodmanufacturingpractices(CGMP)regulationsapply(21CFRparts210and211).Specifically,theguidancediscusseshowtoinvestigatesuspect,orOOStestresults,includingtheresponsibilitiesoflaboratorypersonnel,thelaboratoryphaseoftheinvestigation,additionaltestingthatmaybenecessary,whentoexpandtheinvestigationoutsidethelaboratory,andthefinalevaluationofalltestresults.本指南适用于API、赋形剂和其它组分生产的实验室检验和CGMP法规应用的成品检验。特别的，指...
