1、目的 2、范圍 3、職責(zé) 4、系統(tǒng)描述System 5、文檔 6、數(shù)據(jù)收集D 7、安全注意事項(xiàng)SHE 8、文件確 ation 9、運(yùn)行確認(rèn)過程OQ IQ完成情況的確認(rèn)IQCompletion 人機(jī)界面檢查HMI 運(yùn)行功能確認(rèn)OperationalFunction 和聯(lián)鎖確認(rèn)AlarmsandInterlocks 生產(chǎn)參數(shù)確認(rèn)ProductionParameters 峰流量確認(rèn)PeakFlow 過程確認(rèn)Disinfection 運(yùn)行確認(rèn)過程中偏差匯總OQDeviation 運(yùn)行確認(rèn)總結(jié)OQSummary 10、參考文獻(xiàn) 11、附錄列表Appendix 附錄Appendix 附錄Appendix 附錄Appendix 附錄Appendix 附錄Appendix 附錄Appendix 附錄Appendix 附錄Appendix 附錄Appendix 附錄Appendix 附錄Appendix 附錄Appendix 1、目TheOQistodemonstratethattheoperationofthePWdistributionsystemoftheHAIRUNproductioncontrolbuildingconformtothedesigncriteria.2、范ThisreportisjustapplicabletotheOQofthePWdistributionsystemoftheHAIRUNproductioncontrolbuilding.3、職所有開展的工作將按照《驗(yàn)證管理總則》（HQAM-200）執(zhí)行Allactivitieswillbeexecutedaccordingtothe<ValidationManagementPrinciples>(HQAM-200).列在報(bào)告第二頁(yè)的負(fù)責(zé)和批準(zhǔn) nellistedonthesecondpagetaketheresponsibilityofthereviewingandapprovalofthisreport.凡是參與確認(rèn)測(cè)試的都應(yīng)列在附 檢查測(cè)試簽字單上AllparticipantsshouldbelistedintheAppendix1“TestersSignature凡是參與確認(rèn)測(cè)試的都應(yīng)經(jīng)過的培訓(xùn)，列在附表“培訓(xùn)記Allparticipantsshouldbetrainedofthisreportandlistedonthe“TrainingRecord”（HRMR-009）.(Alloriginalrecordsshouldbearchivedbytheinthetraining,andthecopieswillbeattachedtothequalificationreport).4、系統(tǒng)描述SystemThisPWdistributionsystemisdesigned,manufacturedandinstalledbytheSHANGHAIMACROPROCESSLUSTRATIONTECHNOLOGYCo.,.Themaincomponentsare,pump,heatexchanger,instruments,valvesandpi.Thesystemisindoor-installed,andusedtostorageanddistributionthePurifiedWater.純化水在一個(gè)豎直安放的2m3容量的不銹鋼罐內(nèi)，并通過一個(gè)水泵循環(huán)至ThePWisstoredi ticalSS 3,anddeliveredtoeachusepointbyacentrifugalpump,returntotheSS atlast.ThedistributionpipelineisaDN40piloop,anddistributedbythediaphragmvalves.Adouble-tube-sheetheatexchangerisinstalledonthereturnloopnearthe,andtocontrolthesystemtemperaturebythetemperaturetransmitterswhichlocatedontheide,beforeandaftertheheatexchanger.Alevelmeterislocatedinthe,aimtosuperviseandcontroltheAsprayballisinstalledonthetopoftheinternalofthe,aimtokeeptheinteriorwetted.Aventfilterisinstalledonthetopofthe,soastopreventtheoutsidecontaminantsincaseoftheleveldrop.Electricalheatingjacketisinstalledonthefilterhouse,soastokeepthefiltercartridgedry.Twosamplevalvesarerespectivelyinstalledonthesupplyloopandthereturnloop,soastosamplethePW.Twopressuregaugesarerespectivelyinstalledonthe andafterthepump,soastowatchthepressureoftheandthesupplywater.Alevelmeterisinstalledinthereturnloop,soastocontrolthereturnwatervelocitybymodifyingthepumprotationalrate.Aconductivitytransmitterisinstalledinthereturnloop,soastosupervisetheconductivityofthesystem.Twop aticdiaphragmvalvesareinstalledonthereturnlinewhichnearthe,soastocontrolthePWquality.Whentheconductivitydonotconformtotheacceptancecriteria,thevalvewhichreturntotheclosedasthedischargingvalveopenedtodischargetheunacceptablewater.Otherwisethereturnvalveclosedasthedischargingvalveopened.WhentheCApressurelost,thesetwovalvesareinnormalconditionthatthereturnvalveopenedasthedischargingvalveclosed.5、文檔 OQationmustThisqualificationAllprintedtexts,charts,handwritingrecordsfromthequalificationprocess;所有參加確認(rèn)檢查的簽字單Allparticipants確認(rèn)過程中可能出現(xiàn)的偏差和方案Deviationsandinvestigationplanwhiayoccurduringthequalificationprocess;Finalqualification6、數(shù)據(jù)收集 AllapprovalshouldbewrittenbyblackinkReportshouldbefilledwithablackink說明更改理由。不可刮，不可用橡皮擦，不可用重筆涂改。Protocolorreportshallnotbetornorerased.Ifnecessary,anycorrectionsshouldbecrossedoutwithasingleline,andinitialedanddated.Wherethereasonforadeletionisnotobviousabriefexplanationshouldbeprovided.Thereshouldnotbeanyuseofknifescratches,eraser,andheavypencilerasures.AfterfinishingtheOQ,allresultsfromthequalificationshouldcomeintoaconclusion,andbeformedintoaqualificationreport.7、安全注意事項(xiàng)SHEIfitisnecessarytogetintotheceiling,asafetyhelmetshouldbewornon,andinsomecases,theharnessandsafetyshoesareimportant.Ifitisnecessarytoascendaheightwithaladder,pleaseholdthehandrail,andpaycarefulattentiontopreventsliporfallingdown.8、文件確認(rèn)ationVerifythatthe sareavailabletodirectthewholeOQAllrelevantverificationshouldbebasedontheaforementioned列出每一個(gè)文件并檢查其有效性將檢查結(jié)果記錄在附 2“文件確認(rèn)表List andverifyitsvalidity,andrecordthetestresultsintoAppendix2 ationVerification9、運(yùn)行確認(rèn)過程OQIQ完成情況的確認(rèn)IQCompletion測(cè)試目的Beforethisqualificaiton,theIQReportofthissystemshouldbeapproved,andtherelaventdeviationsduringIQshouldbeclosed.測(cè)試方法Test將結(jié)果記錄于附錄3“IQ完成情況確認(rèn)”。VerifywhethertheIQreporthasbeenapproved,andtheconditionoftheimplementationoftherelevantchangesanddeviations.RecordtheresultsintoAppendix3“IQCompletionVerification”.AcceptanceCriteriaIQ報(bào)告已批準(zhǔn)。IQreporthasbeenRelevantdeviationshavebeenSystemisingoodandnormal人機(jī)界面檢查HMI測(cè)試目的VerifythefunctionofhumanmachineinterfaceofcontrolsystemisinaccordancewithDesign.測(cè)試方法Test符合相應(yīng)的操作權(quán)限。將結(jié)果記錄于附錄4“人機(jī)界面檢查”。Verifythegraphicalpagesincomparisonwiththeprocessandtheactualinstallationintermsofequipment,devicesandinstruments,payattentiontothestatusrepresentation(valves,pumps),oguemeasurement,colors,symbolsandtagnumber,andanyotherdatashownbytheinterface.Verifyscreennavigation(goingfromongraphictoanotherone).Verifythedifferentuserlevelcorrespondtorelevantadministrationfunction.RecordtheresultsintoAppendix4“HMIVerification”.AcceptanceGraphicalpagesrepresenttheactualinstallationoftheAnydigitalstatus,oguedata,symbol,color,tagnumber,instrumentsanddeviceiscorrectlyshownandindicated.Screennavigation(fromapagetothenestandthepreviousone)worksAdministrateuserfunctionconformstotheprocess運(yùn)行功能確認(rèn)OperationalFunction測(cè)試目的Verifythatsystemandthemaincomponentsofthesystemcanprogressexecutionaccordingtothefunctionspecifications.測(cè)試方法Test將結(jié)果記錄于附錄5“運(yùn)行功能確認(rèn)”。Verifytheworksstatusofthecontrolvalves,pumps,heatexchanger,transmittersandfieldinstrumentsinthesystem.Runthesystemaccordingtotheoperationalmanual.Checktheactualworkingstateandcomparewiththepre-definedfunctionspecification.RecordtheresultsintoAppendix5“OperationalFunctionThemaincomponentsinthesystemcannormallyworkaccordingtothefunctionThesystemcanprogressexecutionaccordingtothepre-definedfunction和聯(lián)鎖AlarmsandInterlocks測(cè)試目的Verifythecapabilityofthecontrolsystemtodetect,communicateandreactwhenalarmsandinterlocksconditionoccurred.測(cè)試方法Test修改的閾斷開裝置（傳感器、光電計(jì)、儀表斷開或短接信號(hào)線（僅對(duì)數(shù)字信號(hào)將結(jié)果記錄于附錄6“和聯(lián)鎖確認(rèn)”Foreachalarm/interlock,generatearm/interlockconditionusingoneoftheModifyingthealarmUsingapropersignalDisconnectingthedevice(sensor,photocell,Disconnectingorshortingthesignalcable(digitalsignalsSimulating“realcondition”(e.g.:hightemperaturesimulatedputtingtheelementinthebath).RecordtheresultsintoAppendix6“AlarmsandInterlocksAcceptanceAllalarms/interlocksarecorrectlygeneratedandanyexpectedresultedresultsandactionsduetoalarmstriggeringareverified.生產(chǎn)參數(shù)確認(rèn)ProductionParameters測(cè)試目的Verifytheproductionparameterswithoutopenedpointofuse測(cè)試方法Test導(dǎo)率等。將結(jié)果記錄于附錄7“生產(chǎn)參數(shù)確認(rèn)”。RunthePWdistributionsystem.Withallpointsofuseclosed,recordtheProductionparameters,i.e.level,pressure,flowrate,conductivity,etc.RecordtheresultsintoAppendix7“ProductionParametersVerification”.AcceptanceTheproductionparametersareincompliancewiththeprocess峰流量確PeakFlow測(cè)試目的Verifythecapacityofthestorageanddistributionsystemsduringpeakflow測(cè)試方法Test365nm紫外燈檢查水罐內(nèi)壁無熒光劑影響試驗(yàn)結(jié)0.08g/L0.22g/L的核黃素水溶液，均勻的噴撒在儲(chǔ)罐內(nèi)表面；待峰流量結(jié)束后，用365nm紫外燈檢查內(nèi)表面是否完。將結(jié)果記錄于附錄8“峰流量確認(rèn)”。FeedthePurifiedWaterintothestorageuntilfull.Opencontemporaneouslyallneededpointsofusetosimulatethe umwaterconsumptionforeseenbythedesignedpeakflowrate.Recordtheproductionparameters(storagelevel,waterconductivity,pressure,flowrateetc.).Andexecutetheriboflavinfluorescencetest:Beforethetest,usethe365nmwavelengthUVlamptoinspectinteriorsurfaceforthefluorescencemayimpactthetestresult.Spraythe0.08~0.22g/Lriboflavinaqueoussolutionontheinteriorsurfaceofthe.Afterthepeakflow,inspecttheresultwith365nmUVlamptoverifythatthespraycovereffect.RecordtheresultsintoAppendix8“PeakFlowVerification”.AcceptanceThepeakflowisTheproductionparametersareincompliancewithprocessSprayballcoveragetestingresult過程確認(rèn)Disinfection測(cè)試目的Verifythatthesystemisabletocirculatepurifiedwateratthetemperaturewhichaccordingtothedisinfectionrequirement,withintheentiredistributionloopandfortheentirecycle.測(cè)試方法Test待溫度到達(dá)設(shè)定點(diǎn)(80℃)。在整個(gè)周期內(nèi)（1小時(shí)），每10分鐘記錄下系統(tǒng)中所有溫度探頭的溫度，特別需注意的是關(guān)鍵點(diǎn)（環(huán)路回?zé)峤粨Q器前的冷點(diǎn)）。將結(jié)果記錄于附錄9“過程確認(rèn)”。Besurethatnopointofuseisopen.Usetheheatexchangeronthereturnlooptoheatthepurifiedwater.Waitthereachingofthesetpointtemperature(80℃).Recordthetemperatureevery10minutesfor1hourwhieasuredbyanyprobeofthesystem,payingattentiontothecriticalpoint(specialconcernofcoldspotbeforetheheatexchangeronthereturnloopoftheloop).RecordtheresultsintoAppendix9“DisinfectionAcceptance在整個(gè)周期（達(dá)到設(shè)定值后）內(nèi)所有的監(jiān)測(cè)點(diǎn)的溫度大于80℃。AlltemperaturemeasurementsduringtheDisinfectioncyclearehigherthanthesetpoint(80℃)duringtheentirecycle(afterreachingtheset運(yùn)行確認(rèn)過程中偏差匯總OQDeviation確認(rèn)過程中如或變更，應(yīng)按照《偏差處理標(biāo)準(zhǔn)管理規(guī)程Ifanydeviationsandchangesariseduringthequalificationprocess,<StandardDeviationHandlingProcedure>(HQAM-007)shouldbefollowedtoreportthedeviations,recordtheprocessintotheAppendix10“OQDeviationReport”.Anyresultsoutofspecificationsshouldbeinvestigated.運(yùn)行確認(rèn)總結(jié)OQSummary總結(jié)運(yùn)行確認(rèn)的結(jié)果，將結(jié)論列在11“運(yùn)行確認(rèn)總結(jié)”中。運(yùn)行確認(rèn)合格SummarizetheOQresults,andtheconclusionsshouldbelistedintheAppendix11“OQsummary”.AftertheapprovalofIQ,thenextactivitieswillbeauthorizedtobeexecuted.10、參考文獻(xiàn)《驗(yàn)證管理總則》（HQAM-<GeneralValidationManagementPrinciples>(HQAM-《偏差處理標(biāo)準(zhǔn)管理程序》（HQAM-<StandardDeviationHandlingProcedure>(HQAM-《藥品生產(chǎn)質(zhì)量管理規(guī)范》（2010版(CFDA)GoodManufacturingPractice,revisedinAnnex15totheEUGuidetoGoodManufacturingPractice“Validationand(ISPE)新建和改造的工廠工程指南，第4卷-水和蒸汽系統(tǒng)，第2版1(ISPE)PharmaceuticalEngineeringGuidesforNewandRenovatedVolume4:Waterand systems,InternationalSocietyforPharmaceuticalEngineering,Secondedition,January2011.中國(guó)藥典2010Chinapharmacopoeia2010EuropeanPharmacopoeiathe8th37USPharmacopoeiathe37th11、附錄列表Appendix附錄Appendix文件檢查測(cè)試簽字單TestersSignature1文件確認(rèn)表ationVerification1IQIQCompletion1HMI1OperationalFunction2AlarmsandInterlocks2ProductionParameters1PeakFlow1Disinfection12OQ1附件Attaent1AppendixAppendix檢查測(cè)試簽字單TestersSignatureTrainedor(Yes是/No否Note備注ExecutedbyDateDate文件確認(rèn)表ationVerificationNameDoc(Yes是/No否12P&I3456ExecutedbyDate日期Date日期IQ完成情況確認(rèn)IQCompletion(Yes是/No否1IQIQ23NormalandExecutedbyDate日期Date日期人機(jī)界面檢查HMICheckAcceptanceCheckthegraphicalpagesofthesystemstepbystep.Graphicalpagesrepresenttheactualinstallationofthesystem.Visualcheckwhetheranydigitalstatus,oguedata,symbol,color,tagnumber,instrumentsanddeviceiscorrectlyshown.Anydigitalstatus,oguedata,symbol,color,tagnumber,instrumentsanddeviceiscorrectlyExecuteandcheckthescreennavigationfunctionaccordingtooperationalmanual.(goingfromongraphictoanotherone)按照操作手冊(cè)執(zhí)行并檢查屏幕導(dǎo)航功（從一個(gè)圖形進(jìn)入到另外一個(gè)ScreennavigationworksForeachforeseenuserlevel,enterrespectivelytherightpasswordandwrongpasswordandverifyifaccessisExecutedbyDateDate運(yùn)行功能確認(rèn)OperationalFunctionCheckPass/Checkthepumpisintherightdirectionandnotdeadheadedduringoperation.PumpisrunningwellandnoCheckpaticallyvalvecanopenandclosecorrectlywhenbuttonispressedorreleased.ManualCheckmanualvalvescanbeopened/closedeasilybyCheckregulatingvalvecanberegulatedaccordingtoprocessrequirement.Checkfieldinstruments(leveltransmitter,flowdevice,pressuregaugeandconductivitytransmitter)cancorrectlyCheckPass/NormalCheckPass/Themaincomponentsinthesystemcannormallyworkaccordingtothefunctionspecification.Thesystemcanprogressexecutionaccordingtothepre-definedfunctionExecutedbyDateDateAppendix和聯(lián)鎖確認(rèn)AlarmsandInterlocksCheckExpectedPassorLevelLowPopupAlarmSystemLevelPopupAlarmLevelInletvalveofthePWgenerationOpenLevelInletvalveofthePWgenerationClosedLevelHighPopupAlarmInletvalveoftheTurnedUpWaterReturnValveClosedwithWaterConductivityHighexceedthesetSystemFlowraCheckExpectedPassorYes是/NoAllalarms/interlocksarecorrectlygeneratedandanyexpectedresultedresultsandactionsduetoalarmstriggeringareverifiedExecutedbyDateDateAppendixAppendix生產(chǎn)參數(shù)確認(rèn)ProductionParametersInitialMiddleFinal儲(chǔ)罐Loop循AfterFlowReturn≥Return≤Yes是/NoTheproductionparametersareincompliancewiththeprocessExecutedbyDateDate峰流量確PeakFlo