行业指南_药品检测结果OOS调查指南.doc

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1、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#TABLEOFCONTENTS目录I.INTRODUCTION序言.................

2、..........................................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.....

3、......................................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.........

4、..........................10A.InterpretationofInvestigationResults.调查结果的解释................................10B.Reporting...报告................................................................11ThisguidancehasbeenpreparedbytheOfficeofCompliance/DivisionofManufacturingandProductQuality,CenterforDrugEv

5、aluationandResearch(CDER)attheFoodandDrugAdministration.ThisguidancedocumentrepresentstheAgency’scurrentthinkingonevaluatingOOStestresults.ItdoesnotcreateorconferanyrightsfororonanypersonanddoesnotoperatetobindFDAorthepublic.Analternativeapproachmaybeusedifsuchapproachsatisfiestherequirementsofth

6、eapplicablestatute,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。GUIDANCEFORINDUSTRY1InvestigatingOutofSpecification(OOS)TestResultsforPharmaceuticalProduction行业指南：药品检验结果OOS的调查I.INTRODUCTION序言Thisguidanc

7、eforindustryprovidestheAgency’scurrentthinkingonhowtoevaluatesuspect,oroutofspecification(OOS),testresults.Forpurposesofthisdocument,thetermOOSresultsincludesallsuspectresultsthatfalloutsidethespecificationsoracceptanc