計(jì)算機(jī)系統(tǒng)驗(yàn)證方案

ComputerisedSystemValidation

計(jì)算機(jī)系統(tǒng)驗(yàn)證Dept.部門：EffectiveDate生效日期： Year/Month/月ConfidentialLevel QA/ 質(zhì)量保證部機(jī)密等級(jí)： Date/日□Top-secret絕密口Confidential機(jī)密 口Cryptical秘密DistributionList?: 」 .：，：分發(fā)清單： I；：，；；，；：；QA部、QC部、OSP固體制劑部、Lo.物控部、EN工程部、TD技術(shù)部、EQ設(shè)備部Objective目的TestandassessmentshouldbetakenforURS,design,purchase,installation,function,aswellasprocessadaptabilityofcomputerizedandPLCcontrolsystemrelatedtoGMPincompliancewiththisSOPsoastoensurethatcomputerizedandPLCarefitfordesignrequirementandstatedtechnicalcriteriaandareabletoworkstablyforalongtime.測(cè)試、評(píng)估采取的URS、設(shè)計(jì)、采購(gòu)、安裝、功能以及計(jì)算機(jī)控制和PLC控制系統(tǒng)符合GMP，以確保計(jì)算機(jī)和PLC符合設(shè)計(jì)要求和工藝要求并且能夠穩(wěn)定工作很長(zhǎng)時(shí)間。Scope范圍 ：）二Role責(zé)任人Draft起草人Review審核人Review審核人Review審核人Review審核人Review審核人Review審核人Approve批準(zhǔn)人Dept.部門QAQCOSPLo.ENTDEQQDName姓名Signature簽名Date日期ThisSOPisfitforthevalidationmanagementofcomputerizedandPLCcontrolsystemrelatedtoGMP,whichapplytomaterialcontrolandmanagement,laboratoryequipmentcontrolandcommunicationmanagement,manufacturingprocesscontrol,andutilitiescontrol.本SOP適用于電腦,PLC控制系統(tǒng)的管理是否符合GMP,物料控制和管理,實(shí)驗(yàn)設(shè)備控制和通信管理、生產(chǎn)過程控制、公用設(shè)施的控制的驗(yàn)證。Responsibilities職責(zé) ： 「二QAisresponsiblefordrafting,revising,reviewing,training,implementingandsupervisingthisSOP. .QA負(fù)責(zé)起草、修訂、審核、培訓(xùn)、實(shí)施和監(jiān)督本SOP。ThequalitydirectorisresponsibleforapprovingthisSOP.質(zhì)量副總負(fù)責(zé)批準(zhǔn)本SOP。4RelevantdepartmentsareresponsibleforreviewingandimplementingthisSOP。相關(guān)部門負(fù)責(zé)審核和實(shí)施本SOP。Definitions定義ComputerizedorPLCcontrolsystem:Itcomposedofhardware,systemsoftware,applications,andrelevantperipheraldevicesisasystemthatcanimplementafunctionandasetoffunctions.無論是計(jì)算機(jī)化還是PLC控制系統(tǒng):都是由硬件、系統(tǒng)軟件、應(yīng)用、及相關(guān)的周邊設(shè)備組成的一個(gè)系統(tǒng),可以實(shí)現(xiàn)某一功能和一套功能。Sourcecode:Itissourceprogramofcomputerwhoseformat(programlanguage)canbereadbyoperator,beforecomputerexecution,itshouldbetranslatetomachinelanguagewhoseformatcanbeexecutedbycomputer.源代碼:它是計(jì)算機(jī)的源程序(程序語(yǔ)言)，可以在電腦執(zhí)行前被計(jì)算機(jī)識(shí)別,它應(yīng)該被翻譯成可以被計(jì)算機(jī)識(shí)別的機(jī)器語(yǔ)言。Procedures程序 ，’； 1.一OrganizationofValidationteamandresponsibility驗(yàn)證機(jī)構(gòu)及責(zé)任Validationteamiscomposedofsupplier,QA,EquipmentDepartment,usedepartment..驗(yàn)證團(tuán)隊(duì)由供應(yīng)商,QA、工程設(shè)備部和使用部門組成。Implementationdepartmentresponsibilityofsystemvalidation系統(tǒng)驗(yàn)證實(shí)施部門的職責(zé)Usedepartment:ResponsibleforprovidingwrittenURS,preparingvalidationprotocolandreport,implementingapprovedIQandOQprotocol,completingfinalreportandparticipatingvalidationdeviationinvestigationandalterationreview.使用部門：負(fù)責(zé)提供書面的URS,準(zhǔn)備驗(yàn)證方案和報(bào)告、實(shí)施批準(zhǔn)IQ,OQ協(xié)議，完成最終報(bào)告偏差并參與調(diào)查及變更驗(yàn)證審核。EquipmentDepartment:ResponsibleforcooperatingwithusedepartmenttoprepareURSandvalidationprotocol,receivingsystem,installingsystemandimplementingIQ,guidingusedepartmentonIQandOQprocessandparticipatingvalidationdeviationinvestigationandalterationreview. . 7-設(shè)備部門：負(fù)責(zé)準(zhǔn)備使用部門的合作協(xié)議,并確認(rèn)你接收系統(tǒng),安裝系統(tǒng),實(shí)施IQ,指導(dǎo)使用部門關(guān)于IQ和OQ的驗(yàn)證過程和參與驗(yàn)證偏差調(diào)查和變更回顧。QA:Responsibleforreviewingvalidationdraftandfinalreport,implementingvalidationprotocol,participatingvalidationdeviationinvestigationandalterationapprovalandarchivingvalidationprotocolandreport.QA:負(fù)責(zé)審查驗(yàn)證，也是最后一項(xiàng)報(bào)告草案、實(shí)施驗(yàn)證方案，參與調(diào)查及變更驗(yàn)證偏差的批準(zhǔn)驗(yàn)證方案和歸檔,并做好報(bào)告。Systemclassification系統(tǒng)分級(jí)Beforevalidation,evaluationandclassificationshouldbecarriedoutforsystemsoastoinsurethatdifferentgradevalidationshouldbeprovidedfordifferenttypecomputerizedandPLCcontrolsystem.Classificationasfollows:

在驗(yàn)證之前，評(píng)估和分級(jí)應(yīng)當(dāng)進(jìn)行系統(tǒng)分類，以確保不同等級(jí)驗(yàn)證需提供不同類型的計(jì)算機(jī)化的,PLC控制系統(tǒng),分類如下：ClassificationDescriptionValidationmethod分類描述驗(yàn)證方法ValidateOperatingEstablishednetworkandoperatingsystemnameandsystem,forcommerce.E.g.DOS\Windows95/98NT.editionnetwork已做好網(wǎng)絡(luò)和操作系統(tǒng)例如:DOS\Windowsnumber網(wǎng)絡(luò)操作系統(tǒng)，95/98NT.確認(rèn)名稱及版本號(hào)Thesesystemisdesignedbynon-consumerfordrivingfirmwarewhich canbeStandarddevice,microcontroller,sensitiveequipmentinstalledinspecialintegratecircuit(IC)forapplication,readonlymemory(ROM),randomaccessmemory(RAM),PLCsometimes,suchasbarcodemodem,single-cyclecontroller,fillingdevice,Checkweigher,temperaturecontrolleretc.Validateconstructionandconfiguration標(biāo)準(zhǔn)配置,微控制器,靈敏的電氣設(shè)備這些系統(tǒng)是根據(jù)用戶可以安裝在特殊的集成電路確認(rèn)構(gòu)造及配(IC)的驅(qū)動(dòng)固件，只讀存儲(chǔ)器(ROM)、隨機(jī)存取存儲(chǔ)器(RAM)、PLC,例如條形碼調(diào)制解調(diào)器，single-cycle控制器、灌裝設(shè)備，重量控制、溫度控制器等來設(shè)計(jì)的。置StandardReady-madepackageforcommerce,suchasValidatepackagemultiplansoftware,standardchemicalapplication

標(biāo)準(zhǔn)程序包analysissoftwareetc.現(xiàn)成的軟件包，例如多計(jì)劃軟件，標(biāo)準(zhǔn)化學(xué)分析軟件等。process驗(yàn)證應(yīng)用過程Configurablepackage可配置的程序包Usersdeveloptheirownapplicationthroughpre-definitesoftwaremodulesanddevelopingapplicationmodulescanbecarriedoutinthissystem,suchasmanmachinedialogueport,managementcontrol,dataacquisitionsystem,adaptivecontrolsystemforlaboratory,informationmanagementsystemforlaboratory,materialrequirementplanningsystem,dataprocessingsystemforsystem/applicationandproduct,partPLCetc.用戶自己開發(fā)應(yīng)用可通過pre-definite軟件模塊和發(fā)展應(yīng)用模塊都可以在這個(gè)系統(tǒng)中運(yùn)行,采用人機(jī)對(duì)話端口，管理控制,數(shù)據(jù)采集系統(tǒng)，自適應(yīng)控制系統(tǒng)，信息管理系統(tǒng),原材料需求計(jì)劃系統(tǒng)、數(shù)據(jù)處理系統(tǒng)和產(chǎn)品、系統(tǒng)應(yīng)用部分可編程序控制器(PLC)等。AuditsupplierandvalidateapplicationprocessandsomepreestablishedcodeSystemdevelopedwithinfirm公司內(nèi)部系統(tǒng)開發(fā)Modifyingordevelopingsystemincompliancewithrequirementofhimself修改或開發(fā)符合自己要求的系統(tǒng)ImplementallvalidationprocessesofcomputerizedandPLCcontrolsystem

實(shí)施計(jì)算機(jī)及PLC控制系統(tǒng)驗(yàn)證的全過程SomecomputerizedandPLCcontrolsystemwithcomplexconstructionshouldbeclassifiedinaccordancewithdevelopingdegreeofeachmodule.5.2.2一些計(jì)算機(jī)化的和PLC控制系統(tǒng)復(fù)雜程度應(yīng)當(dāng)跟各分類模塊的開發(fā)程度相一致。5.2.2ValidationofcomputerizedandPLCcontrolsystemshouldbecarriedoutnotonlyforuseprocessofsystem,e.g.validationofnewsystemshouldbecarriedoutnotonlyforinitialdefinitionkanddesigningphasebutalsowholelifecycleofsystemdevelopment.計(jì)算機(jī)驗(yàn)證，PLC控制系統(tǒng)不僅體現(xiàn)在系統(tǒng)使用過程，如新系統(tǒng)的驗(yàn)證不僅在初始定義和設(shè)計(jì)階段進(jìn)行,而且貫穿于全部生命周期體系的發(fā)展。Validationimplementation驗(yàn)證實(shí)施/URSURSshouldbepreparedbysystemuserandprojectexpertdetailedwithfundamentalrequirement,expectationandperformanceindexofnew/changedcomputerizedandPLCcontrolsystem,whichwillbeusetodeterminesystemdesigningcriteria.Contentasfollow:URS應(yīng)該為系統(tǒng)用戶和項(xiàng)目專家準(zhǔn)備基本要求詳細(xì)的，預(yù)期和新的性能指標(biāo)、更改計(jì)算機(jī)化和PLC控制系統(tǒng),可以用來決定系統(tǒng)設(shè)計(jì)標(biāo)準(zhǔn)。內(nèi)容如下:Systemdescription:whattodoaboutsystem,howconnectionandinteractionbetweendifferentmodule,controlmethods(e.g.logiccontrol,separationcontrol,interlockcontrol,alarmcontrol,locationcontrol,temperaturecontrol,pressurecontrol,timecontrol,countingandothermultipolarcontrol),implementingprocess,portsandsafetyrequirementforoperator.系統(tǒng)描述：系統(tǒng)做到什么程度，如何關(guān)聯(lián)不同模塊、控制方法(例如:邏輯控制、分離控制，連鎖控制、報(bào)警控制、位置控制，溫度控制，壓力控制、時(shí)間控制、計(jì)數(shù)和其他多級(jí)控制)、實(shí)施流程、操作員的端口和安全標(biāo)準(zhǔn)。Physicalrequirement:includesufficientspace,location,peripheral2environment,etc. 「物理要求:包括有足夠的空間,位置,周邊環(huán)境等。Documentcriteriaforhardware:includechartpaper,schematicchart,hand3book,sparepartslistetc.硬件的文件標(biāo)準(zhǔn):包括：圖紙,原理圖,操作指南,備件清單等。Documentcriteriaforsoftware:includeprogramnumberandrevisingnumber,4outputprogramanddetailedexplanation,reproductionofsoftwareprovisionandretentioncondition,systemblockdrawingandconfigurationlist.軟件的文件標(biāo)準(zhǔn)：包括程序編號(hào)和修改編號(hào)，輸出接口程序和詳細(xì)說明、軟件的追加和保留條件、系統(tǒng)分程序圖紙和配置清單。Testrequirement:testitemsandrecordrequiredtobecarriedouton5systemdevelopingprocess,includingmoduleseparatedtestandintegratedtest.測(cè)試要求：測(cè)試項(xiàng)目和記錄必須在系統(tǒng)的發(fā)展過程中進(jìn)行，包括模塊測(cè)試和集成分離測(cè)試。Otherrequirementtosupplier:suchasfinishedsystemvalidation,quality6 controlandchangecontrolondevelopingprocess,etc.對(duì)供應(yīng)商的其他要求:如在發(fā)展進(jìn)程中完成系統(tǒng)驗(yàn)證、質(zhì)量控制和變更控制等。5.3.2Systemdesign系統(tǒng)設(shè)計(jì) 「二〕Systemdesignshouldcomposeofsystemconfigurablechartdesign,hardware1 design,andsoftwaredesign.Afterdocumentofsystemdesignreviewedandapprovedbyconsumerwhichshouldbepreparedbysupplier,systemconfigurablechartdesignshouldbecarriedout,includingsystemPID(processandinstrument),I/O(input/output)connectiondiagram,controlelementparetodiagram.系統(tǒng)設(shè)計(jì)應(yīng)該由系統(tǒng)配置圖、硬件設(shè)計(jì)和軟件設(shè)計(jì)組成。在供應(yīng)商準(zhǔn)備的系統(tǒng)設(shè)計(jì)被用戶評(píng)估和檢驗(yàn)后，可配置的系統(tǒng)圖紙?jiān)O(shè)計(jì)應(yīng)該完成，包括系統(tǒng)PID,I/O(輸入/輸出)連接圖、連接原理帕累托圖。Hardwaredesign:includeallI/O(input/output)connectiontemplateand2 type,CPUselection, communicationtemplate, man-machineInterfacecontroller,screenviewerselection,mediumrelay,memory,printer,auxiliarypowerunit,electronicelement/wire/cable,otherelementsetc.硬件設(shè)計(jì):包括所有I/O(輸入/輸出)連接模板和類型,CPU選型，通信模板、人機(jī)界面控制器，屏幕查看選擇、中繼電器、記憶存儲(chǔ)器、打印機(jī)、輔助動(dòng)力裝置，電子部件/電線/電纜、其他元件等。Software:includesystemsoftware,application,anddata.3軟件:包括系統(tǒng)軟件、應(yīng)用和數(shù)據(jù)。5.3..3IQIQshouldbecarriedout，toensure^thatsysteminstallationisfitfordesigncriteriaandneededtechnicaldatashouldbecompletelyprovided.Specialcontentasfollow:,IQ應(yīng)該確保該系統(tǒng)安裝符合設(shè)計(jì)標(biāo)準(zhǔn)和工藝需求，數(shù)據(jù)完全提供。特殊內(nèi)容如下：Documentqualificationshouldconsistofconsumertechnicalguide,SOP,1trainingplan,post-saleserviceagreement,equipmentinventory,securityprogram,hardwarequalification,softwarequalification,sourcecode,instrumentlist,instrumentcalibrationprocedure,PID,controlloopdiagram,I/O(input/output)devicelistandconnectiondiagram,sparepartslist,andmaintenanceprocedure.文件確認(rèn)應(yīng)該由用戶工藝要求、SOP,培訓(xùn)計(jì)劃，售后服務(wù)協(xié)議、設(shè)備庫(kù)存，安全程序、硬件說明，軟件說明，源代碼、儀器清單、儀器校準(zhǔn)程序、PID、控制回路圖,1/。(輸入/輸出設(shè)備清單和連接圖,備件清單和維護(hù)規(guī)程。Installationprocessqualification:qualifythatinstallationisfitfor2requirementPIDandoperatingmanual.安裝過程說明:安裝符合PID和操作手冊(cè)的要求。Circumstanceandutilitiesqualification3事件和實(shí)用程序說明(1)Qualifyandrecordcircumstanceofsysteminstallation,suchascleanlevel,radiofrequency/electromagneticinterference,physicalprotection,temperature,humility,sound,lighting,etc.系統(tǒng)安裝環(huán)境的檢驗(yàn)和記錄：例如潔凈水平、射頻/電磁干擾、物理保護(hù)、溫度、濕度、聲音、照明等。(2)Recordconditionofcriticalutilitiesandqualifythatcriticalnatureofutilitiesshouldbefitforinstructionincludingfirealarmannouncement/prevention,coolingsystem,electricpoweranditsadjustment,continuouspowersupply,wideareanetworkconnection,localareanetworkconnection,disasterrecovery,telephonefigure/analog,etc.記錄關(guān)鍵設(shè)施以及條件，鑒定的公共設(shè)施應(yīng)該跟說明一致：包括消防報(bào)警公告/預(yù)防系統(tǒng)、冷卻系統(tǒng)、電力及調(diào)整，持續(xù)供電、大面積網(wǎng)絡(luò)連接，本地區(qū)域網(wǎng)絡(luò)連接，災(zāi)難恢復(fù)、電話圖形/模擬等(3)Qualifythatrecordsystemisfitforrequirementofman-machineengineer.條件和記錄系統(tǒng)符合人控機(jī)工程師的要求。Systemtestandqualification4系統(tǒng)測(cè)試、條件(1)ThefirststeptodoistoqualifythatreportitemsofFAT(factoryacceptancetest)shouldbecompletelysuppliedbysupplierandfitfordesigncriteria.第一步要做的是，報(bào)告項(xiàng)目FAT的驗(yàn)收測(cè)試應(yīng)該完全由供應(yīng)商提供,適用于設(shè)計(jì)標(biāo)準(zhǔn)。(2)Necessarytestshouldbecarriedoutforsystemonoperationalcircumstance.Essentialcontentasfollow:應(yīng)該對(duì)系統(tǒng)運(yùn)行情況開展必要的測(cè)試?；緝?nèi)容如下：5.3.4Allinstrumentsandmetersshouldbecalibratedandonexpiredayofcalibration.Calibrationshouldbefitfordefinitecriteriaandcorrespondingcertificationshouldbeprovided.所有儀器儀表應(yīng)該被校準(zhǔn)和標(biāo)注過期日，校準(zhǔn)應(yīng)該有明確的標(biāo)準(zhǔn)及應(yīng)提供相應(yīng)的檢查證件。I/O(input/output)signaltestshouldbecarriedoutsoastoensurethatsinglecantransmitfromcontrolsystemtodeviceandreturn.I/O(輸入/輸出)信號(hào)試驗(yàn)應(yīng)確保信號(hào)可以在控制系統(tǒng)設(shè)備間進(jìn)行傳輸和反饋。Dataacquisitionandtransmissionandsignalmemorytest數(shù)據(jù)采集,傳送和信號(hào)記憶測(cè)試Othertests?其他測(cè)試OQ(operationqualification) ''運(yùn)行確認(rèn)ThepurposeofOQisthatallfunctiontestsshouldbecarriedoutonoperationalcircumstancesoastoensurethatsystemandoperationshouldbefitfordesigncriteria.Contentasfollow;OQ的目的是進(jìn)行所有功能運(yùn)行情況方面的測(cè)試以確保系統(tǒng)和運(yùn)行符合設(shè)計(jì)標(biāo)準(zhǔn)，內(nèi)容，如下：Testforsystemsecurity:“worstcase”ofalllogicsystemsshouldbetested,e.g.useauthorityofdifferentpersonsshouldbetestedsoastoidentifythatoperationunauthorizedshouldbeforbidden.測(cè)試系統(tǒng)安全：“最壞情況”的系統(tǒng)邏輯應(yīng)該進(jìn)行測(cè)試，如使用不同權(quán)限以便確認(rèn)未經(jīng)授權(quán)運(yùn)行是否被禁止。Variousprocessescontrolfunctiontestsrequiredbysystemrequest:“worstcase”(e.g.maximumcommunicationload,processofconsiderabledatadocument,etc.)testforallfunctionofsystemanddecisionroutinesshouldbecarriedoutinaccordancewithvariousrequirementsandcriteriasuppliedbysystemdefinition.(Itisimportantthatafunctionaldiagramincludingallbranchroutinesshouldbeprovided.)根據(jù)系統(tǒng)要求進(jìn)行的各種各樣的過程控制功能的測(cè)試：“最壞情況”(例如最大通信承載、過程相當(dāng)大的數(shù)據(jù)文件等)試驗(yàn)檢查系統(tǒng)和決策程序的功能，應(yīng)根據(jù)系統(tǒng)不同的要求和標(biāo)準(zhǔn)提供的定義。(提供功能圖表包括所有出現(xiàn)的偏差是非常重要的。)Testforalarmandinterlock:efficacyofcorrespondingprogramshouldbetestedontheconditionofalarmandinterlockforsysteminaccordancewithsystemoperationmanual.檢測(cè)報(bào)警及連鎖:程序連鎖應(yīng)根據(jù)報(bào)警條件及系統(tǒng)連鎖操作手冊(cè)進(jìn)行測(cè)試。Testfortimerandsequencer:establishtimeandprogramofsystemgeneratingcorrespondingfunctionaccordingtosystemoperationmanualsoastovalidateefficacyofsystemtimingororderingprogram.定時(shí)器和定序器測(cè)試：根據(jù)系統(tǒng)的操作手冊(cè)設(shè)置時(shí)間和系統(tǒng)產(chǎn)生相應(yīng)的功能以確認(rèn)系統(tǒng)有效時(shí)間或程序命令Testfordatadisposalandmemory測(cè)試數(shù)據(jù)處理和記憶(1)Qualifycorrectdatamemory,collectionandsearchofsystem'sown.正確的數(shù)據(jù)記憶,準(zhǔn)確的數(shù)據(jù)采集和系統(tǒng)的自我搜索的確認(rèn)。(2)Qualifydisposalofdataoutputlength,carryandempty數(shù)據(jù)處理的輸出長(zhǎng)度、承載和空載的確認(rèn)(3)Qualifythefunctionofsavingdatatocorrespondingfolder.數(shù)據(jù)保存到相應(yīng)文件夾的功能確認(rèn)。Testforshutdown/recovery關(guān)機(jī)/恢復(fù)測(cè)試. (1)Checkconditionofthedataacquisitionbeforeandaftershutdownsoas6 toensurethatdatahavenotbeendamagedorlost.在系統(tǒng)關(guān)閉之前和之后檢查數(shù)據(jù)采集的情況,確保數(shù)據(jù)沒有損壞或丟失。(2)Checkthefunctionofbackuppowersupply,uninterruptiblepowersupply,poweradjusterandpowergenerator.

檢查備用電源的供應(yīng)、不間斷電源供應(yīng)器、電力調(diào)節(jié)器和電力發(fā)電機(jī)。(3)Systembreakdownsorfailuresshouldbemadeinaccordancewithsystemoperationmanualsoastoensurethatback-upsystemshouldbeprovided.系統(tǒng)故障和失敗的時(shí)候,能夠根據(jù)系統(tǒng)的操作手冊(cè)提供系統(tǒng)備份。Otherfunctiontest其他功能測(cè)試5.3.4.Performancequalification(PQ)75.3.4.性能確認(rèn)5.3.5ThepurposeofPQisthatqualifytheefficacyandstabilityofrunning5.3.5processonoperationalcircumstance.Testitemsshouldbeestablishedinaccordancewithachievingdesiredresultandduplicatequalificationshouldbealsocarriedout.PQ的目的是確認(rèn)系統(tǒng)運(yùn)行過程中的有效性和穩(wěn)定性方面的情況。測(cè)試項(xiàng)目應(yīng)確定跟期望達(dá)到的結(jié)果相一致、二次確認(rèn)也應(yīng)該執(zhí)行。Ifsystemispartofproduction,laboratoryorutilities,PQofsystemshouldbecompletedconformitywithPQofequipment(utilities).

如果系統(tǒng)是生產(chǎn),實(shí)驗(yàn)室或公共設(shè)施系統(tǒng)的一部分,系統(tǒng)的PQ必須根據(jù)設(shè)備的PQ進(jìn)行完整性測(cè)試。.IfamanualsystemisbeingreplacedbycomputerizedandPLCcontrol1system,thetwoshouldberuninparallel.當(dāng)一個(gè)人工系統(tǒng)被電腦,PLC控制系統(tǒng)取代時(shí),兩者需要平行運(yùn)行。.Regardingtoproductionequipment,thetestforproductspecification,suchasassay,testforpackagingspecification,etc,shouldbecarriedoutsoastoensurethattheallprocesscontrolfunctionsareeffective.Testsshouldbecarriedoutforatleast3consecutivebatchesonthesomeproductioncondition.對(duì)于生產(chǎn)設(shè)備,要進(jìn)行產(chǎn)品規(guī)格測(cè)試,如化驗(yàn)、包裝規(guī)格測(cè)試等等,確保所有的過程控制功能都是有效的，應(yīng)當(dāng)在相同的生產(chǎn)的條件下進(jìn)行至少3個(gè)連續(xù)批次的測(cè)試。Monitoringforequipmentofconsecutiveprocessdisposalshouldbecarriedout,e.g.indexofclean-airsystem,suchasdustparticle,microorganism,temperature,humidity,airflow,pressuredifference,airexchangefrequency,etc,shouldbemonitoredduringaperiod.對(duì)設(shè)備的連續(xù)過程進(jìn)行監(jiān)控應(yīng)當(dāng)進(jìn)行，如空氣凈化體系的指標(biāo)，例如塵埃粒子、微生物、溫度、濕度、風(fēng)量、壓差、換氣頻率等，應(yīng)在一個(gè)周期內(nèi)被監(jiān)控。Validationdeviation偏差驗(yàn)證Thedisposalofsystemvalidationdeviationcanreferto<ValidationOrganizationandImplementation〉.處置系統(tǒng)偏差驗(yàn)證可參閱〈驗(yàn)證組織和實(shí)施>。Changecontrol變更控制Changeclassification:changeiscomposedofhardwarechange,softwarechangeandchangeofcriticalparametersindatabase.變更的分類:變更是由硬件變更、軟件變更，和數(shù)據(jù)庫(kù)的臨界參數(shù)變更組成。Ifchangeoccurring,changecontrolshouldbecarriedoutsoastoensurethatsystemshouldbe