文档介绍：HistoryofPharmaceuticalQualityManagement药品质量管理的历史1960’sandbefore:Reliantsolelyonqualitycontrol20世纪60年代以前:仅仅依靠质量控制FocusedontheProductSpecification专注于产品质量标准Defectdetectionbyendproducttesting通过最终产品测试来检测缺陷Advantage优势Sometimesdetectsdefects有时能检测出缺陷Disadvantage劣势Faultsfoundtoolate故障发现为时已晚Oftenfails经常失败Highcost成本高1HistoryofPharmaceuticalQualityManagement药品质量管理的历史Early1970’s:addedqualityassurance&GMP20世纪70年代早期:增加了质量保证和GMPWrittenprocedures书面规程Focusonproductionprocess侧重于生产过程Defectpreventionusingprocesscontrols通过过程控制来预防缺陷Advantages优势Documentedsystems书面记录的系统Improvedquality提高了质量2ANewApproachtoRegulation(PAT)过程分析技术(PAT)Processunderstanding过程的理解Controlin-processratherthanend-producttesting对过程进行控制,而非对最终产品进行检测Minimizerisksofpoorquality质量低劣风险最小化Identifytheparametersthatarecriticaltoproductquality确定对产品质量关键的参数Measuretheseparameters测量这些参数Controltheseparameters(feedback,feedforward)控制这些参数(反馈、前馈)3PharmaceuticalQualitySystem药品质量体系4ICHQ8,Q9,Q10Aharmonizedpharmaceuticalqualitysystemapplicableacrossthelifecycleoftheproductemphasizinganintegratedapproachtoqualityriskmanagementandscience开发一个和谐完整的制药质量体系,该体系强调风险管理与科学一体化,并贯穿于整个药品生产周期Q8,pharmaceuticaldevelopment药物开发Q9,qualityriskmanagement质量风险管理Q10,pharmaceuticalqualitysystem药品质量体系5ICHQ8“PharmaceuticalDevelopment”“药物开发”7Q8deliverables交付Productqualityandperformanceachievedandassuredbydesignofeffectivemanufacturingprocesses产品的质量及性能是由产品的有效设计及生产工艺的有效性来实施和确保的Productspecificationsbasedonmechanisticunderstandingofhowformulationandprocessfactorsimpactproductperformance产品标准是建立在对配方及产品性能的工艺影响因素等机械原理理解的基础之上Anabilitytoaffectcontinuousimprovementandcontinuous“realtime”assuranceofquality达到持续改进及不断的实时质量监控的能力8Q8Concepts概念Informationfrompharmaceuticaldevelopmentstudiesisthebasisforriskmanagement(usingQ9)药物开发研究过程中所获得的信息是风险评估的基础(用Q9)。Identifycriticalparameters,he“designspace”这项评估有助于定义“设计空间”binationandinteractionofinputvariables(.,materialattributes)andprocessparametersthathavebeen