摘要自2002年美国FDA提出的21世纪以风险为基础的CGMP以来，以风险为基础的法规体系和质量管理体系已逐渐广泛应用于欧洲、美国、日本等全球各医药卫生领域。中国SFDA2011年发布的《药品生产质量管理规范（2010年）》中也引进了风险管理程序，要求建立以风险为基础的质量管理体系。并明确提出应基于风险确定验证范围和验证程度。本文以一条粉针注射剂生产线为例，通过分析粉针剂生产线的组成和影响因素和对验证的需求，讲述通过风险管理程序如何确定出该生产线的验证范围和程度，确证基于风险确定验证范围和验证程度是有效和必要的。基于风险确定验证范围和验证程度，能够将有限的资源着重于确认该生产线重要的或关键的组成及影响因素，从而确保产品质量，实现验证应有的目的和价值。关键词：风险；验证范围；验证程度；粉针剂IThenecessityToDefinetheValidationScopeandDegreeBasedonRisk-TakethePowderInjectionProductionLineForExampleSince“PharmaceuticalCGMPfor21stCenturyBasedOntheRisk”wasproposedbyUSFDAin2002,RegulationandQualitysystembasedonriskisincreasinglywideutilizedinEurope,USA,Japanandalmostgloballyhealthcareindustry.RecentlyissuedChineseSFDAGMP2010alsointroducedtheriskmanagementprogram.TheQualitySystemBasedOnRiskisrequired,andalsomakeitclearthatshoulddefinethevalidationscopeanddegreebasedonrisk.Thethesistakesapowderinjectionproductionlineforexample,describehowtodefinethescopeanddegreeofthevalidationworkbyanalysisthepowderinjectionproductionlinecomponents,qualityimpactelements,andthevalidationrequirements,thentoprovethatitiseffectiveandnecessarytodefinethevalidationscopeanddegreebasedontherisk.Definethevalidationscopeanddegreebasedontheriskcanfocusthelimitedresourcestoqualifyorvalidatetheimportantorcriticalcomponentsorqualityimpactelements,toensuretheproductsqualityandrealizethegoalandvalueofvalidationfinally.KeyWords:Risk,Validationscope,ValidationDegree,PowderInjectionII目录第一章前言............................................................................................................................................1第二章粉针剂产品质量属性和生产工艺分析.....................................................................................22.1粉针剂产品质量属性.................................................................................................................22.2粉针剂产品生产工艺.................................................................................................................22.3粉针剂生产线组成和影响因素.................................................................................................4第三章粉针剂生产线验证需求分析.....................................................................................................53.1验证概述/目的...........................................................................................................................53.2粉针剂生产线对验证的需求.....................................................................................................8第四章风险评估程序..........................................................................................................................124.1“以风险为基础”的由来.........................................................................................................124.2风险评估的管理程序..............................................................................................................134.3风险评估方法........................................................................................
