ICH-Q9质量风险管理

QualityRiskManagement/质量风险管理翻译：徐禾丰1INTERNATIONALCONFERENCEONHARMONISATIONOFTECHNICALREQUIREMENTSFORREGISTRATIONOFPHARMACEUTICALSFORHUMANUSE人用药注册技术要求国际协调会议ICHHarmonisedTripartiteGuideline人用药注册技术要求国际协调会议三方协调后的指南QualityRiskManagement质量风险管理CurrentStep4version现行第四步版本dated9November20052005年十一月9日ThisGuidelinehasbeendevelopedbytheappropriateICHExpertWorkingGroupandhasbeensubjecttoconsultationbytheregulatoryparties,inaccordancewiththeICHProcess.AtStep4oftheProcessthefinaldraftisrecommendedforadoptiontotheregulatorybodiesoftheEuropeanUnion,JapanandUSA.本指南由人用药注册技术要求国际协调会议专家工作组根据人用药注册技术要求国际协调会议程序开发并提交各方的药政部门咨询。根据人用药注册技术要求国际协调会议程序第四步，推荐给欧盟、日本和美国药的政部门采用的最终文本。DocumentHistory文件历史Codification最初编码History历史ApprovalbytheSteeringCommitteeunderStep2andreleaseforpublicconsultation.指导委员会批准第二步文件并发放用于公开咨询Date日期Q922March20052005/3/22ApprovalbytheSteeringCommitteeofPostStep2correction指导委员会在批准第二步后的订正文件15June20052005/6/15CurrentStep4version现行第四步版本ApprovalbytheSteeringCommitteeunderStep4andrecommendationforadoptiontothethreeICHregulatorybodies.指导委员会批准第四步文件并推荐ICH三方药政部门批准9November20052005/11/9QualityRiskManagement/质量风险管理翻译：徐禾丰2HavingreachedStep4oftheICHProcessattheICHSteeringCommitteemeetingon9November2005,thisguidelineisrecommendedforadoptiontothethreeregulatorypartiestoICH在2005年11月9日的人用药注册技术要求国际协调会议上，本指南已经通过人用药注册技术要求国际协调会议第四步程序，本指南已经推荐给人用药注册技术要求国际协调会议三方的药政部门采用。QualityRiskManagement/质量风险管理翻译：徐禾丰3TABLEOFCONTENTS目录1.INTRODUCTION简介................................................................................12.SCOPE范围............................................................................23.PRINCIPLESOFQUALITYRISKMANAGEMENT质量风险管理的原则............24.GENERALQUALITYRISKMANAGEMENTPROCESS常规质量风险管理程序.....24.1Responsibilities职责.....................................................................................44.2InitiatingaQualityRiskManagementProcess启动质量风险管理过程.......44.3RiskAssessment风险评估...................................................................44.4RiskControl风险控制....................................................................54.5RiskCommunication风险沟通.....................................................................64.6RiskReview风险评审..................................................................65.RISKMANAGEMENTMETHODOLOGY风险管理方法学...................................76.INTEGRATIONOFQUALITYRISKMANAGEMENTINTOINDUSTRYANDREGULATORYOPERATIONS质量风险管理与业界及药政运行整合..................................................87.DEFINITIONS定义.........................................................................98.REFERENCES参考文献.................................................................11Annex附录I:RiskManagementMethodsandTools风险管理方法与工具...12I.1BasicRiskManagementFacilitationMethods基本风险管理简易方法.......12I.2FailureModeEffectsAnalysis故障模式效应分析(FMEA)..........................12I.3FailureMode,EffectsandCriticalityAnalysis故障模式影响与严重性分析(FMECA)....................................................13I.4FaultTreeAnalysis故障树分析(FTA)........................................13I.5HazardAnalysisandCriticalControlPoints危害分析关键控制点(HACCP)....................................................................14I.6HazardOperabilityAnalysis危害及可操作性分析(HAZOP)..................14I.7PreliminaryHazardAnalysis预先危险分析(PHA)...................................15QualityRiskManagement/质量风险管理翻译：徐禾丰4I.8RiskRankingandFiltering风险排序及过滤........................15I.9SupportingStatisticalTools辅助性统计工具............................................16Annex附录II:PotentialApplicationsforQualityRiskManagement实施质量风险管理的潜在机会.......................................16II.1QualityRiskManagementasPartofIntegratedQualityManagement整合质量管理部分的质量风险管理....................16II.2QualityRiskManagementasPartofRegulatoryOperations药政操作部分的质量风险管理...........................................18II.3QualityRiskManagementasPartofdevelopment开发部分的质量风险管理..................................................................19II.4QualityRiskManagementforFacilities,EquipmentandUtilities厂房，设备和公用设施的质量风险管理..................19II.5QualityRiskManagementasPartofMaterialsManagement物料管理部分的质量风险管理..........................................21II.6QualityRiskManagementasPartofProduction生产部分的质量风险管理......................................................................21II.7QualityRiskManagementasPartofLaboratoryControlandStabilityStudies实验室控制和稳定性研究部分的质量QualityRiskManagement质量风险管理风险管理....................................22II.8QualityRiskManagementasPartofPackagingandLabelling包装和标签部分的质量风险管理...................................22QualityRiskManagement/质量风险管理翻译：徐禾丰51.INTRODUCTION导言Riskmanagementprinciplesareeffectivelyutilizedinmanyareasofbusinessandgovernmentincludingfinance,insurance,occupationalsafety,publichealth,pharmacovigilance,andbyagenciesregulatingtheseindustries.Althoughtherearesomeexamplesoftheuseofqualityriskmanagementinthepharmaceuticalindustrytoday,theyarelimitedanddonotrepresentthefullcontributionsthatriskmanagementhastooffer.Inaddition,theimportanceofqualitysystemshasbeenrecognizedinthepharmaceuticalindustryanditisbecomingevidentthatqualityriskmanagementisaval