欧盟GMP附录11-计算机系统(中英文对照).doc

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1、.EUROPEANCOMMISSION欧盟委员会HEALTHANDCONSUMERSDIRECTORATE-GENERAL卫生与消费者协会PublicHealthandRiskAssessment公共卫生与风险评估Pharmaceuticals药品Brussels,SANCO/C8/AM/sl/ares(2010)1064599EudraLexTheRulesGoverningMedicinalProductsintheEuropeanUnion欧盟药品生产规Volume4卷4GoodManufacturing

2、PracticeMedicinalProductsforHumanandVeterinaryUse人用与兽用药品良好生产管理规Annex11:ComputerisedSystems附件11：计算机系统Legalbasisforpublishingthedetailedguidelines:Article47ofDirective2001/83/EContheCommunitycoderelatingtomedicinalproductsforhumanuseandArticle51ofDirective2001

3、/82/EContheCommunitycoderelatingtoveterinarymedicinalproducts.Thisdocumentprovidesguidancefortheinterpretationoftheprinciplesandguidelinesofgoodmanufacturingpractice(GMP)formedicinalproductsaslaiddowninDirective2003/94/ECformedicinalproductsforhumanuseandDir

4、ective91/412/EECforveterinaryuse.依法发布的具体指导针：2001/83/EC第47条人用药品规和2001/82/EC第51条兽用药品规。此文件为2003/94/EC人用药品和91/412/EEC兽用药品GMP法规、指导针的解释提供了指导。Statusofthedocument:revision1文件版本：修订本1Reasonsforchanges:theAnnexhasbeenrevisedinresponsetotheincreaseduseofcomputerisedsyst

5、emsandtheincreasedcomplexityofthesesystems.ConsequentialamendmentsarealsoproposedforChapter4oftheGMPGuide.修订原因：为增强计算机系统的功能和复杂性而修订此附件。相应修正案也已被提议作为GMP指南的第4章。Deadlineforcomingintooperation:30June2011生效时间：2011年6月30日Word资料.Principle总则Thisannexappliestoallformsofc

6、omputerisedsystemsusedaspartofaGMPregulatedactivities.Acomputerisedsystemisasetofsoftwareandhardwarecomponentswhichtogetherfulfillcertainfunctionalities.此附件适用于符合GMP生产要求的所有形式的计算机系统。计算机系统是实现某项特定功能的软件和硬件的组合。Theapplicationshouldbevalidated;ITinfrastructureshould

7、bequalified.应用程序应验证，IT基础设施应有权限设置。Whereacomputerisedsystemreplacesamanualoperation,thereshouldbenoresultantdecreaseinproductquality,processcontrolorqualityassurance.Thereshouldbenoincreaseintheoverallriskoftheprocess.用计算机系统代替手动操作应不对产品质量、过程控制和质量保证以及过程的整体风险产生影响

8、。General常规1.RiskManagement风险管理Riskmanagementshouldbeappliedthroughoutthelifecycleofthecomputerisedsystemtakingintoaccountpatientsafety,dataintegrityandproductquality.Aspartofariskmanagementsyste