ISPE-10.调试和确认

COMMISSIONINGANDQUALIFICATION调试和确认10.COMMISSIONINGANDQUALIFICATION10.调试和确认INTRODUCTION简介Commissioningandqualificationcomprisethevalidationprocessbywhichasystemisputintoserviceanddemonstratedtoconsistentlyproducewaterofaspecifiedquality,undervariousconditions,whileoperatedundersetprocedures.Althoughcommissioningandqualificationaretypicallyseparatedwithinaprojectschedule,theyareinessence,onecontinuousprocess.调试和确认是一个验证过程，是将系统投入使用并证明其在设定规程的不同条件下运转时始终能生产合格水质的过程。虽然在一个项目进步表中可以将调试和确认分离开，但本质上它们是一个连续过程。ThespecificactivitiesandprocessesduringcommissioningandqualificationwillnotbediscussedinthisGuide.TheseareconsideredbyaseparateISPEBaseline®GuideonCommissioningandQualificationandpharmaceuticalwatersystemsareusedasexamplesthroughout.Asummaryofkeyconceptsarelistedbelow:本指南中不讨论调试和确认期间的特定活动和过程。这些在一个单独关于调试和确认的ISPE基线®指南中会有所考虑，并且制药用水系统也在各处被用作例子。关键概念总结如下：a)Duetotheinterdependencebetweenactivitiesandthoseinvolved,excellentcommunication,planningandcoordinationbetweenoperations,engineering,commissioning,andvalidationpersonnelwillenabletimelyandcost-effectiveprojectcompletion.鉴于活动它们涉及的相互依赖性，操作、工程、调试和验证人员之间的沟通、计划和协调将能及时且低本高效地完成。b)Eachcomponentofthesystemshouldbebuiltinaccordancewithplansandspecificationsandshouldbeinspected,tested,anddocumentedbyqualifiedindividuals.Theseactivities,andtheproductionofsupportingdocumentation,aredefinedasGoodEngineeringPractice(GEP).嵌入的每个系统组件都应当符合计划和规定，并且应当由具有资质的人员检查测试并用文件记实。这些活动以及编制的支持文件都应当按照良好工程规范（GEP）进行规定。c)GEPrecommendsaminimumlevelofdocumentationforallsystemsandequipment.Thisencompassesdesign,fabrication,vendortesting,construction,fieldinspection,andcommissioning.Ifthesedocumentsareappropriatelyplanned,organized,andauthorized,theymaybecomeanintegralpartofqualificationsupportdocumentation,thusavoidingredundancyandsavingtimeandmoney.GEP为所有系统和设备推荐了最低级别的文件，包括设计、装配、供应商测试、建造、现场检查及调试。如果这些文件都经适当的计划、组织及认可，那么它们就可以整合成确认支持文件，从面避免了重复，节省了时间和金钱。d)Designcriteriaanddocumentationrequirementsshouldbeclearlydefinedearlyinthedesignphase,toensureclearexpectationsandappropriateplanning,andfacilitatetimelycommissioningandvalidation.Engineeringfirms,vendors,andcontractorsshouldberequired,perthesystemspecifications,toprovidethenecessarydocumentation,toavoidunnecessarycostsanddelaysassociatedwithobtainingorcreatingthesedocuments.在设计阶段初期就应当明确规定出设计标准和文件要求，从而确保目的明确，计划适当且调试和验证推进及时。每种系统规格中，都应当要求工程公司、供应商以及承包商提供必需的文件，从而避免因为取得或起草这些文件产生的不必要的花费和延误。e)Duringconstruction,timelyreviewofdocumentationandperiodicwalk-throughscanensurethatInstallationQualificationrequirementsaremet.建造期间，及时检查文件并定期“导览”能够确保达到安装确认的要求。f)Commissioningtakesthesystemfromastateofsubstantialcompletiontoastateofoperation.ItisthePhaseofaprojectthatincludesmechanicalcompletion,start-up,andturnover.Commissioningincorporatesasystematicmethodoftestinganddocumentingthesystemattheconclusionofconstruction,andpriortothecompletionofvalidationactivities.调试是将系统从完成状态带入运行状态。是一个包括机械完工、启动并循环的项目阶段。调试具体表现为建造后验证活动完成前之间的测试和文件记录系统的系统化方法。g)Commissioningdocumentsshouldnotbecreatedandexecutedforthepurposeofregulatorycompliance.However,commissioningtestsanddocumentationwilltypicallysatisfymanyinstallationandoperationalqualificationrequirements.调试文件的编制和执行不应当只是为了顺应法规。但是，调试检测及文件将满足大多数安装和运行确认要求。SYSTEMQUALIFICATIONDOCUMENTATION系统确认文件GoodEngineeringPracticedictatesthatdocumentationbedevelopedtoprovideevidenceofthedesign,andthatthewatersystemoperationsinaccordancewiththedesign.Thisdocumentationencompassesengineering,installation,inspection,andtesting.Suchdocumentationiscommontoallsystemcommissioningactivitiesandispartiallysummarizedbelow:良好工程规范规定起草文件来证明设计以及水系统的运行符合设计要求。此文件包括工程技术、安装、检查以测试。此类文件是所有系统调试活动共有的，特别总结如下：•Asystemdescriptionstatingdesignintent说明设计意图的系统描述•Aschematicdrawingofthesystem(P&ID)系统概略图（P&ID）•Writtensystemspecifications编写的系统规定•Detaileddesigndrawings详细的设计图纸•Vendormanualsanddrawings供应商手册和图纸•Fieldinspectionandtestreports现场检查和测试报告•Systemqualificationtestresults系统确认测试结果Becauseoftheircriticalimpactonpharmaceuticalproduction,watersystemsrequireadditionalemphasisoncertainsectionsofthisdocumentation.SpecificdesignrequirementsforwaterandsteamsystemsarecontainedwithinthebodyofthisGuide.Whencompilingdocumentationrelatedtowatersystems,particularattentionshouldbepaidtothefollowing:由于它们对制药产品的重大影响，水系统需要对这些文件的特定部分做额外强调。水和蒸汽系统的特殊设计要求包括在本指南的主体之内。当编辑文件和水系统有关时，应当特别注意以下几点：a)Schematicdocumentationmaybeenhancedbytheinclusionofasystemisometricdiagram(ordiagrams)indicatinglocationandnumberingofwelds,relativeelevations,slopeoflines,andpointsofdrainage.可以用一个系统等大的图（或多图）来增强图式文件，该图上标明了焊接的搁置和编号、相对高度、管线倾斜度以及排水点。b)Thesystemspecificationshouldindicateperformancecriteria,aswellasdesignparameters.系统规定中应当指明性能标准，以及设计参数。c)Fieldinspectionandtestreportsshouldincludecleaningandpassivationprocedureandrecord,weldparameterdocumentationandinspectionreports,slopeverification,andverificationoftheabsenceofdead-legs.现场检查和测试报告应当包括清洁和钝化的规程及报告，焊接参数文件和检查报告、倾斜验证，以及“盲管”缺乏的验证。d)Systemqualificationtestsmayormaynotbesubjecttoapre-approvedprotocoladdressingqualificationtestrequirements.Ineithercase,testresultsshouldbereportedindirectcomparisont