55Month/月ionEQMonth/月ionEQ設機密質(zhì)量保證部口CrypticalComputerisedSystemValidat計算機系統(tǒng)驗證Dept.部門：EffectiveDate生效日期：Year/ConfidentialLevel機密等級：□Confidential

QA□Top-secret□Confidential

QA密DistributionList?:分發(fā)清單：QA部、QC部、OSF固體制劑部、Lo.物控部、EN工程部日呷6技術(shù)部、備部 日1Objective目的Role責任人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批準人Dept.部門QAQCOSPLo.ENTDEQQDName姓名Signature簽名Date日期TestandassessmentshouldbetakenforURS,design,purchase,installation,function,aswellasprocessadaptabilityofcomputerizedandPLCcontrolsystemrelatedtoGMPincomplianeewiththisSOPsoastoensurethatcomputerizedandPLCarefitfordesignrequirementandstatedtechnicalcriteriaandareabletoworkstablyforalongtime.測試、評估采取的URS設計、采購、安裝、功能以及計算機控制和 PLC控制系統(tǒng)符合GMP以確保計算機和PLC符合設計要求和工藝要求并且能夠穩(wěn)定工作很長時間。Scope范圍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，實驗設備控制和通信管理、生產(chǎn)過程控制、公用設施的控制的驗證。Responsibilities職責QAisresponsiblefordrafting,revising,reviewing,training,implementingandsupervisingthisSOP.QA負責起草、修訂、審核、培訓、實施和監(jiān)督本 SOPThequalitydirectorisresponsibleforapprovingthisSOP.質(zhì)量副總負責批準本SOP。RelevantdepartmentsareresponsibleforreviewingandimplementingthisSOP。相關(guān)部門負責審核和實施本SOP。Definitions定義ComputerizedorPLCcontrolsystem:Itcomposedofhardware,systemsoftware,applications,andrelevantperipheraldevicesisasystemthatcanimplementafunctionandasetoffunctions.無論是計算機化還是PLC控制系統(tǒng)：都是由硬件、系統(tǒng)軟件、應用、及相關(guān)的周邊設備組成的一個系統(tǒng),可以實現(xiàn)某一功能和一套功能。Sourcecode：Itissourceprogramofcomputerwhoseformat(programlanguage)canbereadbyoperator,beforecomputerexecution,itshouldbetranslatetomachinelanguagewhoseformatcanbeexecutedbycomputer.源代碼：它是計算機的源程序(程序語言),可以在電腦執(zhí)行前被計算機識別,它應該被翻譯成可以被計算機識別的機器語言。Procedures程序

ofValidationteamandresponsibility驗證機構(gòu)及責任Validationteamiscomposedofsupplier,QA,EquipmentDepartment,usedepartment.驗證團隊由供應商，QA、工程設備部和使用部門組成。ImpIementationdepartmentresponsibilityofsystemvalidation系統(tǒng)驗證實施部門的職責Usedepartment:preparing validation protocolapprovedIQandOQprotocol,participating validationalterationreview.Responsible for providingandreport,

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and使用部門ofValidationteamandresponsibility驗證機構(gòu)及責任Validationteamiscomposedofsupplier,QA,EquipmentDepartment,usedepartment.驗證團隊由供應商，QA、工程設備部和使用部門組成。ImpIementationdepartmentresponsibilityofsystemvalidation系統(tǒng)驗證實施部門的職責Usedepartment:preparing validation protocolapprovedIQandOQprotocol,participating validationalterationreview.Responsible for providingandreport,

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and使用部門：負責提供書面的URS準備驗證方案和報告、實施批準協(xié)議,完成最終報告偏差并參與調(diào)查及變更驗證審核。EquipmentDepartment: Responsiblefor cooperating withusedepartmenttoprepareURSandvalidationprotocol,receivingsystem,installing systemandimpiementing IQ,guiding usedepartmentonIQandOQprocessandparticipatingvalidationdeviationinvestigationandalterationreview.設備部門：負責準備使用部門的合作協(xié)議，并確認你接收系統(tǒng)，安裝系統(tǒng),實施IQ,指導使用部門關(guān)于IQ和OQ的驗證過程和參與驗證偏差調(diào)查和變更回顧。QA:Responsible forreport, impiementingvalidation deviationreviewingvalidationvalidation protocol,investigation andalterationIQ,OQdraftandfinalparticipatingapprovalandarchivingvalidationprotocolandreport.QA:負責審查驗證，也是最后一項報告草案、實施驗證方案及變更驗證偏差的批準驗證方案和歸檔，并做好報告。Systemclassification系統(tǒng)分級validation,evaluationandclassificationshouldbecarriedoutforsystemsoastoinsure thatshouldbeprovided for differentcontrolsystem.Classificationasfollows:在驗證之前，評估和分級應當進行系統(tǒng)分類,參與調(diào)查validationdifferent gradetypecomputerized andPLC,以確保不同等級驗證需提供不Description描述Validationmethod驗證方法Description描述Validationmethod驗證方法Operating

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developedforapplication,(ROM),randomPLCsometimes,suchasmodem, single-cyclefilling device,temperaturecontroller這些系統(tǒng)是根據(jù)用戶可以安裝在特殊的集成電路(IC)的驅(qū)動固件，只讀存儲器(ROM)隨機存取存儲器(RAM)、PLC,例如條形碼調(diào)制解調(diào)器,single-cycle控制器、灌裝設備，重量控制、溫度控制器等來設計的。Ready-madepackageforcommerce,suchasmultiplansoftware, standardchemicalanalysissoftwareetc.現(xiàn)成的軟件包，例如多計劃軟件，標準化學分析軟件等。Usersdeveloptheirownapplicationthroughpre-definitesoftwaremodulesanddevelopingapplicationmodulescanbecarriedoutinthissystem,suchasman-machinedialogueport,managementcontrol,dataacquisitionsystem,adaptivecontrolsystemforlaboratory,informationmanagementsystemforlaboratory,materialrequirementplanningsystem,dataprocessingsystemforsystem/applicationandproduct,partPLCetc.用戶自己開發(fā)應用可通過pre-definite件模塊和發(fā)展應用模塊都可以在這個系統(tǒng)中運行,采用人機對話端口，管理控制，數(shù)據(jù)采集系統(tǒng)，自適應控制系統(tǒng)，信息管理系統(tǒng)，原材料需求計劃系統(tǒng)、數(shù)據(jù)處理系統(tǒng)和產(chǎn)品、系統(tǒng)應用部分可編程序控制器(PLC)等。 ModifyingordevelopingsystemincomplianeewithrequirementofValidate

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開發(fā)himself修改或開發(fā)符合自己要求的系統(tǒng)processesofcomputerizedandPLCcontrolsystem實施計算機及PLC控制系統(tǒng)驗證的全過程computerized andPLCcontrol systemwithcomplexconstructionshouldbeclassifiedinaccordaneewithdevelopingdegreeofeachmodule.一些計算機化的和PLC控制系統(tǒng)復雜程度應當跟各分類模塊的開發(fā)程度相一致。ofcomputerizedandPLCcontrol systemshouldbecarriedoutnotonlyforuseprocessofsystem,.validationofnewsystemshouldbecarriedoutnotonlyforinitialdefinitionanddesigningphasebutalsowholelifecycleofsystemdevelopment.計算機驗證,PLC控制系統(tǒng)不僅體現(xiàn)在系統(tǒng)使用過程，如新系統(tǒng)的驗證不僅在初始定義和設計階段進行，而且貫穿于全部生命周期體系的發(fā)展。Validationimplementation驗證實施531 URSexpertexpectation andandPLCcontrolsystem designingexpertexpectation andandPLCcontrolsystem designingperformaneeindexofnew/changedcomputerizedsystem,whichwillbeuseto determinecriteria.Contentasfollow:,預期和新的性能指URS,預期和新的性能指標、更改計算機化和 PLC控制系統(tǒng)，可以用來決定系統(tǒng)設計標準。內(nèi)容如下：process,portsandsafetyrequirementforoperator.Systemdescription:whattodoaboutsystem,howconnectionandinteractioncontrol,locationcontrol,betweendifferentseparation control,control, temperaturecounting andothermodule,interlockcontrol,multipolarSystemdescription:whattodoaboutsystem,howconnectionandinteractioncontrol,locationcontrol,betweendifferentseparation control,control, temperaturecounting andothermodule,interlockcontrol,multipolarcontrolcontrol,pressurecontrol),methods.logicalarmcontrol,control, timeimplementing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、報警控制、位置控制,溫度控制,制、分離控制,連鎖控制、報警控制、位置控制,溫度控制,壓力控制、時間控制、計數(shù)和其他多級控制Physicalrequirement:peripheralenvironment,etc.物理要求:包括有足夠的空間)、實施流程、操作員的端口和安全標準。includesufficientspace,location,,位置,周邊環(huán)境等。Documentcriteriaforhardware:includechartpaper,schematicchart,handbook,sparepartslistetc.硬件的文件標準:包括:圖紙,原理圖,操作指南,備件清單等。Documentcriteriaforsoftware:revisingnumber,outputprogramreproductionofsoftwareprovisionincludeprogramanddetailedandretentionnumberandexplanation,condition,systemblockdrawingandconfigurationlist.軟件的文件標準:包括程序編號和修改編號件的追加和保留條件、系統(tǒng)分程序圖紙和配置清單。Testrequirement:testitemsandrecordrequiredoutonsystemdevelopingprocess,includingtestandintegratedtest.測試要求:測試項目和記錄必須在系統(tǒng)的發(fā)展過程中進行集成分離測試。Otherrequirementtosupplier:suchasvalidation,qualitycontrolandchangecontrolprocess,etc.,輸出接口程序和詳細說明、軟tobecarriedmoduleseparated,包括模塊測試和finishedsystemondeveloping對供應商的其他要求:如在發(fā)展進程中完成系統(tǒng)驗證、質(zhì)量控制和變更控制等。.2.1Systemdesign系統(tǒng)設計Systemdesignshouldcomposeofsystemconfigurablechartdesign,hardwaredesign,andsoftwaredesign.Afterdocumentofsystemdesignreviewedandapprovedbyconsumerwhichshouldbepreparedbysupplier,systemconfigurablechartdesignshouldbecarriedout,includingsystemPID(processandinstrument),I/O(input/output)connectiondiagram,controlelementparetodiagram.系統(tǒng)設計應該由系統(tǒng)配置圖、硬件設計和軟件設計組成。在供應商準備的系統(tǒng)設計被用戶評估和檢驗后，可配置的系統(tǒng)圖紙設計應該完成,包括系統(tǒng)PID,I/O(輸入/輸出)....3machineInterfacecontroller，screenviewerselection，mediumrelay，memory，printer，auxiliarypowerunit，electronicelement/wire/cable，otherelementsetc.硬件設計：包括所有I/O（輸入/輸出）連接模板和類型，CPU選型,通信模板、人機界面控制器，屏幕查看選擇、中繼電器、記憶存儲器、打印機、輔助動力裝置，電子部件/電線/電纜、其他元件等。Software:includesystemsoftware，application，anddata.軟件:包括系統(tǒng)軟件、應用和數(shù)據(jù)。IQisshouldbeIQshouldbecarriedouttoensurethatsysteminstallationfitfordesigncriteriaandneededtechnicaldatacompletelyprovided.Specialcontentasfollow:IQ應該確保該系統(tǒng)安裝符合設計標準和工藝需求，數(shù)據(jù)完全提供。容如下:Documentqualificationguide,SOP,trainingequipmentinventory,softwarequalification,sourcecode,instrumentlist,instrumentcalibrationprocedure,PID,controlloopdiagram,I/O(input/output)devicelistandconnectiondiagram,sparepartslist,andmaintenanceprocedure.文件確認應該由用戶工藝要求、SOP培訓計劃，售后服務協(xié)議、設備庫存，安全程序、硬件說明,軟件說明,源代碼、儀器清單、儀器校準程序、PID、控制回路圖，1/0(輸入/輸出設備清單和連接圖，備件清單和維護規(guī)程。Installationprocessqualification:qualifythatinstallationisfitforrequirementPIDandoperatingmanual.安裝過程說明：安裝符合PID和操作手冊的要求。Circumstanceandutilitiesqualification事件和實用程序說明(1)Qualifyandrecordcircumstanceofsysteminstallation，suchascleanlevel，radiofrequency/electromagneticinterference，physicalprotection，temperature，humility，sound，lighting，etc.系統(tǒng)安裝環(huán)境的檢驗和記錄:例如潔凈水平、射頻/電磁干擾、物理保護、溫度、濕度、聲音、照明等。shouldplan,security特殊內(nèi)technical

agreement,consistofconsumerpost-saleserviceprogram，hardwarequalification，Recordcondition ofcriticalutilitiesandqualifythatcriticalnatureofutilitiesshouldbefitforinstructionincludingfirealarmannouncement/prevention,coolingsystem,electric powerandits adjustment, continuous powersupply,wideareanetworkconnection, localareanetworkconnection,disasterrecovery,telephonefigure/analog,etc.記錄關(guān)鍵設施以及條件，鑒定的公共設施應該跟說明一致：包括消防報警公告/預防系統(tǒng)、冷卻系統(tǒng)、電力及調(diào)整，持續(xù)供電、大面積網(wǎng)絡連接地區(qū)域網(wǎng)絡連接，災難恢復、電話圖形/模擬等man-Qualifythatrecordsystemisfitforrequirementofmachineengineer.man-條件和記錄系統(tǒng)符合人控機工程師的要求。5.3.3Systemtestandqualification.4■ 系統(tǒng)測試、條件ThefirststeptodoistoqualifythatreportitemsofFATby(factory acceptancetest)shouldbecompietely suppliedbysupplierandfitfordesigncriteria.第一步要做的是，報告項目FAT的驗收測試應該完全由供應商提供，適用于設計標準。Necessarytestshouldbecarriedoutforsystemonoperationalcircumstanee.Essentialcontentasfollow:應該對系統(tǒng)運行情況開展必要的測試。基本內(nèi)容如下：instruments andmetersshouldbecalibratedandonexpiredayofcalibration. Calibration shouldbefitfordefinitecriteriaandcorrespondingcertificationshouldbeprovided.所有儀器儀表應該被校準和標注過期日，校準應該有明確的標準及應提供相應的檢查證件。I/O(input/output)signaltestshouldbecarriedoutsoastoensurethatsinglecantransmitfromcontrolsystemtodeviceandreturn.I/O(輸入/輸出)信號試驗應確保信號可以在控制系統(tǒng)設備間進行傳輸和反饋。Dataacquisitionandtransmissionandsignalmemorytest數(shù)據(jù)采集,傳送和信號記憶測試Othertests?其他測試OQ(operationqualification)運行確認

ThepurposeofOQisthatallfunction testsshouldbecarriedoutonoperationalcircumstancesoastoensurethatsystemandoperationshouldbefitfordesigncriteria.Contentasfollow;oc的目的是進行所有功能運行情況方面的測試以確保系統(tǒng)和運行符合設計標準，內(nèi)容如下：Testforsystemsecurity:“worstcase”ofalllogicsystemsshouldbetested,.cessescontrol“worstcaseofconsiderableofsystemanddecisionVariousrequest:processfunction測試系統(tǒng)安全:“最壞情況”的系統(tǒng)邏輯應該進行測試processescontrol“worstcaseofconsiderableofsystemanddecisionVariousrequest:processfunctionfunctiontestsrequiredbysystem“(.maximumcommunicationload,datadocument,etc.)testforallroutinesshouldbecarriedoutinaccordancewithvariousrequirementsandcriteriasuppliedbysystemdefinition.(Itisimportantthatafunctionaldiagramincludingallbranchroutinesshouldbeprovided.)根據(jù)系統(tǒng)要求進行的各種各樣的過程控制功能的測試:“最壞情況”(例如最大通信承載、過程相當大的數(shù)據(jù)文件等)試驗檢查系統(tǒng)和決策程序的功能,應根據(jù)系統(tǒng)不同的要求和標準提供的定義。(提供功能圖表包括所有出現(xiàn)的偏差是非常重要的。)Testforalarmandinterlock:efficacyofcorrespondingprogramshouldbetestedontheconditionofalarmandinterlockforsysteminaccordancewithsystemoperationmanual.檢測報警及連鎖:程序連鎖應根據(jù)報警條件及系統(tǒng)連鎖操作手冊進行測試。Testfortimerandsequencer:establishtimeandprogramofsystemgeneratingcorrespondingfunctionaccordingtosystemoperationmanualsoastovalidateefficacyofsystemtimingororderingprogram.定時器和定序器測試:根據(jù)系統(tǒng)的操作手冊設置時間和系統(tǒng)產(chǎn)生相應的功能以確認系統(tǒng)有效時間或程序命令535535535535534.65.7Testfordatadisposalandmemory測試數(shù)據(jù)處理和記憶(1)Qualifycorrectdatamemory,collectionandsearchofsystem'sown.正確的數(shù)據(jù)記憶，準確的數(shù)據(jù)采集和系統(tǒng)的自我搜索的確認。(2) Qualifydisposalofdataoutputlength,carryandempty數(shù)據(jù)處理的輸出長度、承載和空載的確認Qualifythefunction ofsaving datato correspondingfolder.數(shù)據(jù)保存到相應文件夾的功能確認。Testforshutdown/recovery關(guān)機/恢復測試Checkcondition ofthedataacquisitionbeforeandaftershutdownsoastoensurethatdatahavenotbeendamagedorlost.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。Checkthefunctionofbackuppowersupply, uninterruptiblepowersupply,poweradjusterandpowergenerator.檢查備用電源的供應、不間斷電源供應器、電力調(diào)節(jié)器和電力發(fā)電機。Systembreakdownsorfailuresshouldbemadeinaccordaneewithsystemoperationmanualsoastoensurethatback-upsystemshouldbeprovided.系統(tǒng)故障和失敗的時候，能夠根據(jù)系統(tǒng)的操作手冊提供系統(tǒng)備份。Otherfunctiontest其他功能測試Performaneequalification(PQ)性能確認ThepurposeofPQisthatqualifytheefficacyandstabilityofrunningprocessonoperationalcircumstanee.Testitemsshouldbeestablishedinaccordaneewithachievingdesiredresultandduplicatequalificationshouldbealsocarriedout.PQ的目的是確認系統(tǒng)運行過程中的有效性和穩(wěn)定性方面的情況。測試項目應確定跟期望達到的結(jié)果相一致、二次確認也應該執(zhí)行。Ifsystemispartofproduction,laboratoryorutilities,PQofsystemshouldbecompletedconformitywithPQofequipment(utilities).如果系統(tǒng)是生產(chǎn)，實驗室或公共設施系統(tǒng)的一部分，系統(tǒng)的PQ必須根據(jù)設備的PQ進行完整性測試。Ifamanualsystemisbeingreplacedbycomputerizedcontrolsystem,thetwoshouldberuninparallel.當一個人工系統(tǒng)被電腦，PLC控制系統(tǒng)取代時，兩者需要平行運行。Regardingtoproductionequipment,thetestforspecification,suchasassay,testforpackagingspecification,etc,shouldbecarriedoutsoastoensurethattheallprocesscontrolfunctionsareeffective.Testsshouldbecarriedoutforatleast3consecutivebatchesonthesomeproductioncondition.對于生產(chǎn)設備,要進行產(chǎn)品規(guī)格測試,如化驗、包裝規(guī)格測試等等有的過程控制功能都是有效的，應當在相同的生產(chǎn)的條件下進行至少連續(xù)批次的測試。andPLCproduct,確保所3個Monitoringforequipmentofconsecutiveprocessdisposalshouldbecarriedout,.indexparticle,microorganism,pressuredifference,airmonitoredduringaperiod.ofclean-airsystem,suchtemperature,humidity,exchangefrequency,etc,asairshouldbedustflow,對設備的連續(xù)過程進行監(jiān)控應當進行,如空氣凈化體系的指標子、微生物、溫度、濕度、風量、壓差、換氣頻率等監(jiān)控。,例如塵埃粒,應在一個周期內(nèi)被Validationdeviation偏差驗證disposalofsystemvalidationdeviationValidationOrganizationandImplementation>.處置系統(tǒng)偏差驗證可參閱<驗證組織和實施>。canreferto<6767Changecontrol變更控制classification:changeiscomposedofhard