（医疗药品管理）行业指南药品检测结果OOS调查指南.docVIP

（医疗药品管理）行业指南药品检测结果OOS调查指南 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.DepartmentofHealthandHumanServices FoodandDrugAdministration CenterforDrugEvaluationandResearch(CDER) September1998 CP# TABLEOFCONTENTS目录 I.INTRODUCTION序言...........................................................1 II.BACKGROUND.背景...........................................................1 III.IDENTIFYINGANDASSESSINGOOSTESTRESULTSOOS检验结果的判断和评估....2 ResponsibilityoftheAnalyst检验员的责任.........................................2 B.ResponsibilitiesoftheSupervisor主管的责任...........................................3 IV.INVESTIGATINGOOSTESTRESULTSOOS检验结果的调查.....................5 A.GeneralInvestigationalPrinciples..一般调查原则..................................5 B.LaboratoryPhaseofanInvestigation.实验室的调查阶段................................6 V.CONCLUDINGTHEINVESTIGATION..调查结论...................................10 A.InterpretationofInvestigationResults.调查结果的解释................................10 B.Reporting...报告................................................................11 ThisguidancehasbeenpreparedbytheOfficeofCompliance/DivisionofManufacturingandProduct Quality,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。 GUIDANCEFORINDUSTRY1 InvestigatingOutofSpecification(OOS)TestResults forPharmaceuticalProduction 行业指南：药品检验结果OOS的调查 I.INTRODUCTION 序言 ThisguidanceforindustryprovidestheAgency’scurrentthinkingonhowtoevaluatesuspect,oroutofspecification(OOS),testresults.Forpurposesofthisdocument,thetermOOSresultsincludesa