ISPE-Good-Engineering-Practice良好的工程质量管理规范GEP(95Pag

ISPEGoodPracticeGuide国际制药工程协会：良好的实践指南GoodEngineeringPractice良好的工程质量管理Preface绪言ThisISPEGoodPracticeGuide:GoodEngineeringPractice(GEP)aimstoprovidebothadefinitionandexplanationofthetermGoodEngineeringPractice.TheGuidecoversthecompletelifecycleofengineering,fromconcepttoretirement,anddescribesthefundamentalelementsofGEPastheyshouldexistinpharmaceuticalandrelatedindustries.此指南：旨在推动对GEP规定的概念和原则的共同理解及解释术语“良好的工程实践”。以及介绍的基本要素中他们应该存在于医药及相关产业，并且描述了应该存在于制药和相关产业的基本元素。ItbringstogetherawealthofinformationonGEPandprovidestoolstoallowbenchmarkingofcurrentcompanypracticesagainstwhatisconsideredindustrygoodpractice它汇集了GEP丰富的信息并且提供了现代的、被认为是行业的良好做法工具。TheGuideincludesattachmentswhichprovideindustryexamples,currentlyinuse,ofGEPandauditingmethods,togetherwithcheckliststhatmaybeofusetothereader.该指南包含的附件提供了行业的例子，目前使用的方法，以及审计方法，连同可供审稿人使用的清单。Acknowledgements鸣谢TheISPEGoodPracticeGuide(GPG):GoodEngineeringPractice(GEP)wasproducedbyaTaskTeamledbyChrisDerrett{Schering-PloughCorp.,USA)andMarkFoss(BoehringerIngelheimLtd.,UnitedKingdom).Themembersofthetaskteamcontributedandreviewednewmaterial.JohnAndrewsAndrewsConsultingEnterprisesLtd.UnitedKingdomJoesphBerkaFluorUSANualaCalnanPMGroupIrelandTimCroninBoehringerIngelheimUnitedKingdomNickDaviesGlaxoSmithKlineUnitedKingdomFrankDeMarinisPurduePharmaLPUSAPhilDeSantisSchering-PloughCorp.USARoderickFreemanTevaParenteralMedicinesUSANickHaycocksAmgenUSAStephenHigham,PEGenzymeCorp.USALesHuffmanCommissioningAgentsInc.USABobLennonCommissioningAgentsInc.USAThomasMeldgaardPetersenAlfaNordicDenmarkNeilWinkcupPfizerLtd.UnitedKingdomTheTaskTeamLeaderswouldliketoexpresstheirgratefulthankstothefollowingTeamMecontributionastechnicalreviewersoftheGuide:anveerAhmedABBLtd.UnitedKingdomJohnBeresfordHadenFreemanLtd.UnitedKingdomDwayneM.DavisShawStone&WebsterUSAPetterGallonAstraZenecaABSwedenAngeloGattoSigmaTauSpAItalyElizabethMartinezFloresTerraFarmaSADeCVMexicoDeepakK.ShukiaRanbaxyLaboratoriesLtd.IndiaTechnicalDocumentsProcessandTechnologySubcommitteeChairpersonJanECGustafssonNovoNordiskA/SDenmarkTheISPEGPG:GEPTaskTeamwouldliketothankISPEfortechnicalwritingandeditingsupportbyGailEvans(ISPETechnicalDocumentsWriter/Editor)andSionWyn(ISPETechnicalConsultant).TableofContents目录1Introduction71.1Overview概述1.2Purpose目的1.3ScopeandBenefitObjectives范围和效益目标81.4KeyConcepts关键概念1.5StructureoftheGuide结构的指南2BreadthandCoverageofGEP11GEP的广度和范围3GoodEngineeringPractice良好的工程实践133.1CoreConcepts核心内容3.3ProjectEngineering项目工程153.3CommonPractices常见的实践方法3.4OperationsandMaintenance操作和维护324Appendix1-ExplanationofExampleEngineeringManagementProcess39附录1-解释示范工程管理过程5Appendix2-GlossaryandAcronyms41附录2-词汇和缩略语5.1Glossary词汇表6AcronymsandAbbreviations缩略语和缩写7Appendix3–References45附录三—参考资料8Attachments47附件TableofAttachments/附件目录IntroductiontotheAttachments/附件介绍47AttachmentAPrinciplesofGoodEngineeringPractices51附件AGEP遵循的原则AttachmentBProjectQualityPlanning59附件B工程质量策划AttachmentCProjectUserRequirementsSpecification(URS)71附件C工程用户需求说明书AttachmentDProjectRiskAnalysis77附件D工程风险分析AttachmentECostManagementandReporting83附件E成本管理报告AttachmentFSiteDevelopmentPlan89附件F工厂发展计划AttachmentGProjectExecutionPlan103附件G项目执行计划AttachmentHProjectChangeControl105附件F项目变更控制AttachmentISystemUserRequirementsSpecification(URS)113附件I系统用户需求说明书AttachmentJDesignReview121附件J设计评审AttachmentKMaintenanceTestCertification131附件K维护测试认证AttachmentLFacilityCommissioning137附件L设备调试AttachmentMProjectGMPAssessment145附件M工厂GMP评估AttachmentNSettingSystemBoundaries153附件N设置系统边界AttachmentOCommissioningPlan157附件O调试计划AttachmentPCommissioningPlanCompressedAirSupply165附件P压缩空气供应调试计划AttachmentQPMCompletionChecklist181附件Q项目管理业务完成清单AttachmentRAuditTemplate183附件R审计模板AttachmentSSupplierQualityQuestionnaire187附件S供应商质量调差问卷1Introduction/引言ThisISPEGoodPracticeGuideaimstoprovideadefinitionandexplanationofthetermGoodEngineeringPractice(GEP).ItdescribesthefundamentalelementsofGEPastheyshouldexistinpharmaceuticalandrelatedindustries.Itshouldbenotedthattheconceptsarefundamentalandapplicableinmanyindustries.此指南：旨在推动对GEP规定的概念和原则的共同理解及解释术语“良好的工程实践”。以及介绍的基本要素中他们应该存在于医药及相关产业，并且描述了应该存在于制药和相关产业的基本元素。1.1Overview/概述InthecontextofpharmaceuticalengineeringandGxPguidance,GEPisfrequentlyreferredtoindocumentsasaprerequisitetocomplianceactivityandmaybelooselydefined.GEPisoftenusedtodescribeanengineeringmanagementsystemthatisexpectedinaregulatedcompany,butwhichisnotmandatedbyGxPregulations.Forexample,effectiveprojectprogressmonitoringandcontrolisnotaregulatoryissue,butisnecessaryfortheefficientoperationofacompany,andispartofGEP.在制药工程和GxP指导中，GEP经常在遵守活动和不严格定义的文件中作为前提被提到。GEP经常被用来描述一个控制投资公司工程管理系统的规定，但GxP（药品质量管理规范）中没有此类强制规定。例如，有效的项目进度监测和控制不是一个调整问题的办法，但是对一个高效运营的公司来说是必须的，然而这只是GEP的一部分内容。ThisGuideconsiderstheentirerangeofpharmaceuticalengineeringactivityandidentifieskeyattributesofGEPwithinit,includinghowGEPrelatesto,andinterfaceswithGxP.ThescopeofGEPcoversthecompletelifecycleofengineeringfromconcepttoretirement.GEPprovidesafoundationrequiredacrossthepharmaceuticalindustryuponwhichotherareas,suchasGxP,build.本指南考虑了整个范围的制药工程活动和确定GEP的关键属性，包括了如何将GEP关联起来以及和GxP之间的影响