PDA-TR59用于工艺监控的统计方法

UtilizationofStatisticalMethodsForProductionMonitoringTechnicalReportNo.59控制图：单值......................................................203.3MOVINGRANGECONTROLCHARTS移动极差控制图............................................223.4AVERAGEANDVARIABILITYCHARTS均值图和变异性图........................................233.5HISTOGRAMS柱状图................................................................................................243.6PROCESSCAPABILITY(CPK,PPK)工艺能力（CPK，PPK）..................................283.7EXPONENTIALLYWEIGHTEDMOVINGAVERAGECHARTS指数加权移动平均控制图323.8CUSUMCHARTS累积和图.......................................................................................343.9EXAMPLESOFEFFICIENTMIXTUREOFTHESTATISTICALTOOLBOX统计工具箱有效混合使用的实例..............................................................................................................354.0ACCEPTANCESAMPLING验收抽样...................................................................374.1TYPICALAPPLICATIONS典型应用............................................................................374.2KEYTERMS关键术语...............................................................................................374.3TYPESOFSAMPLING抽样类型...............................................................................384.4TYPESOFACCEPTANCEPLANS接收方案类型......................................................384.5PROSANDCONS优缺点.........................................................................................395.0APPENDICES:TECHNICALDETAILSANDEXAMPLES附件：技术细节和实例415.1RUNCHARTS运行图...............................................................................................41控制图表：单值..................................................435.3MOVINGRANGECONTROLCHARTS移动极差控制图............................................485.4AVERAGEANDVARIABILITYCHARTS均值图和变异性图........................................525.5HISTOGRAMS直方图.................................................................................................655.6CPK＇，PPKFORPROCESSCAPABILITY过程能力CPK,PPK值.................................665.7EXPONENTIALLYWEIGHTEDMOVINGAREACHARTS(EWMA)指数加权移动区域图（EWMA）.....................................................................................................................715.8CUSUMCHARTS累积和图.......................................................................................745.9SAMPLING抽样........................................................................................................80，statisticalmethodshavebeenrediscoveredasvitaltoolsforsuccessfuldevelopmentandmanufacturing.Industrieslikeautomotive，electronics，andconsumerproductsgrowandchangepartlyasaresultofadoptingstatisticalmethods.随着生产商期望提高产品质量，统计方法逐渐成为开发和生产成功的重要工具。汽车、电子、消费品行业也部分因为采用统计方法发展和改变。Thepharmaceuticalandbiopharmaceuticalindustryincreasinglyrecognizestheimportanceofstatisticalmethodstoconsistentlycreateproductsthatconformtopredeterminedqualitycharacteristics.Statisticalmethodsprovideobjectiveevidenceinmeetingthisgoalandarefundamentalforunderstandingtheprocess，whichenablesfurtherimprovementanddevelopment.制药和生物制药工业越来越认识到统计方法的重要性，以持续生产符合预定质量标准的产品。统计方法为符合这一目的提供了客观证据，也是理解工艺的基础，使持续改进和开发成为可能。Industryandregulatorybodiesareworkingtogethertoprovideguidanceandframeworksontheuseofstatisticalmethods.TheInternationalConferenceonHarmonization，InternationalStandardsOrganizationandEuropeanUnionhaveprovidedguidanceontheuseofstatisticalmethods.工业和监管部门正在一起努力建立统计方法使用指南和框架。ICH、ISO、EU已经有了统计方法的指南。Inlightoftheincreasedfocusonthistopic，thisPDATaskForcerecognizedtheneedtoprovideguidancetohelpcompaniesidentifyandusestatisticalmethods.TheprimaryobjectiveofthisTaskForcewastoconveytheappropriateuseofstatisticalmethodsatalevelmostcanunderstand.鉴于人们对这一主题越来越重视，PDA工作组认识到应该建立指南帮助公司识别和使用统计方法。该工作组的基本目的是让大多数人能够适当应用统计方法。1.1PurposeandScope目的和范围Thepurposeofthisdocumentistopresentrelevantandeasy-to-usestatisticalprocesscontrol(SPC)methodsthatareapplicabletothepharmaceutical/biopharmaceuticalindustry.Advancedstatisticalmethods，suchasmultivariatemodelsandDesignofExperiment(DoE)willnotbeconsidered.AnoverviewofacceptancesamplingisalsoincludedinSection4.0.本文件是为了提供的相关、易用的统计过程控制方法，以应用于制药/生物制药工业。高级统计方法，如多变量模型和试验设计（DoE）不包含在内。4.0节对接收取样进行了概述。1.2ImplementationtoSupportDecisionMaking利用统计方法为决策提供支持Statis