USP分析儀器確認(rèn)中英文對照

<1058>ANALYTICALINSTRUMENTQUALIFICATION分析儀器的確認(rèn)INTRODUCTION介紹Alargevarietyoflaboiatoiyequipment,instillments,andcomputenzedanalyticalsystems,langingfiomsmiplenitrogenevaporatorstocomplexmultiple-fiinctionteclmologies(seeIiistninientCategories,areusedmthephaimaceuticalindustiytoacquiiedatatohelpensurethatproductsaresuitablefortheirintendeduse.Ananalyst'sobjectiveistoconsistentlyobtamleliableandvaliddatasuitablefbitheintendedpurpose.Dependmgontheapplications,usersvalidatethenpioceduies,calibratetheninstnunents,andpeifbimadditionalinstnunentchecks,suchassystemsuitabilitytestsandanalysisofin-piocessqualitycontiolchecksamplestohelpensurethattheacquueddataarereliable.Withtheincieasingsophisticationandautomationofanalyticalinstnunents.anmcieasingdemandhasbeenplacedonuserstoqualifythenmstniinents.極其多種多樣的實(shí)驗(yàn)室設(shè)備、儀器、計(jì)算機(jī)分析系統(tǒng)，從簡單的氮吹儀到復(fù)雜的多功能技術(shù)(見儀器種類，被應(yīng)用于制藥工業(yè)，以取得數(shù)據(jù)來確保產(chǎn)品適合其預(yù)定用途。分析員的目標(biāo)是持續(xù)地獲得適合其意圖的可靠和有效的數(shù)據(jù)。取決于具體的應(yīng)用,使用者驗(yàn)證其方法、校準(zhǔn)其儀器，并進(jìn)行額外的儀器檢查，例如系統(tǒng)適用性測試和中間質(zhì)量控制檢查樣品的分析，以便幫助確保所獲得的數(shù)據(jù)是可靠的。隨著分析儀器的復(fù)雜性和自動(dòng)化程度不斷增加，使用者已經(jīng)感受到了不斷增加的確認(rèn)其儀器的要求。Unlikemethodvalidationandsystemsuitabilityactivities,analyticalHistnnnentqualification(AIQcurrentlyhasnospecificguidance01pioceduies.Competingopimonsexistregardingnistnnnentqualificationandvalidationproceduresandtherolesandresponsibilitiesofthosewhopeiformthem.Consequently,variousappioacheshavebeenusedfbiinstnimentqualification,approachesthatreqirnevaiyingamountsofresourcesandgeneratewidelydifferingamountofdocumentation.ThischapterprovidesascientificapproachtoAIQandconsidersAIQasoneofthemajorcomponentsrequuedfbigeneratingreliableandconsistentdata.Notethattheamountofngoiappliedtothequalificationprocesswilldependonthecomplexityandintendeduseoftheiiistminentation.ThisapproachemphasizesAIQ'splaceintheoverallprocessofobtainingthereliabledatafiomanalyticalinstillments.不同于驗(yàn)證和系統(tǒng)適用性工作，分析儀器的確認(rèn)(AIQ目前尚沒有具體的指導(dǎo)方針或程序。關(guān)于儀器確認(rèn)和驗(yàn)證程序，以及這些程序的執(zhí)行者的角色和職責(zé),存在著相互沖突的多種觀點(diǎn)。由此導(dǎo)致，多種方法已經(jīng)應(yīng)用于儀器確認(rèn)，而這些方法要求使用的資源數(shù)量各異并產(chǎn)生數(shù)量差距很大的文檔。此通則為AIQ提供了科學(xué)的方法,并將AIQ視為產(chǎn)生可靠和一致的數(shù)據(jù)所必需的主要組成部分之一。注意，應(yīng)用到確認(rèn)過程的嚴(yán)格程度將由該儀器的復(fù)雜性和預(yù)定用途來決定。這個(gè)方法強(qiáng)調(diào)了AIQ在從分析儀器中獲得可靠數(shù)據(jù)的全過程中的位置。ValidationversusQualification驗(yàn)證對確認(rèn)Intluschapter,thetermvalidationisusedfbimanufacnuingprocesses,analyticalprocedures,andsoftwaiepioceduiesandthetermqualificationisusedfbiinstnuneiits.Thus,thepluase^analyticaliiistnimentqualification”(AIQisusedfbitheprocessofensuringthatannistnnnentissuitableforitsmtendedapplication.在此通則中，驗(yàn)證一詞用于生產(chǎn)工藝、分析方法、軟件程序，而確認(rèn)一詞用于儀器。因此,“分析儀器的確認(rèn)”(AIQ一詞用于確保儀器適用于其預(yù)定用途的過程。COMPONENTSOFDATAQUALITY數(shù)據(jù)質(zhì)量的組成部分Theieaiefotucnticalcomponentsinvolvedinthegenerationofreliableandconsistentdata(qualitydata.Figure1showsthesecomponentsaslayeredactivitieswithmaqualitytriangle.Eachlayeraddstotheoverallquality.Analyticalinstillmentqualificationformsthebasefbigeneratingqualitydata.Theothercomponentsessentialfbigeneiatingqualitydataareanalyticalmethodvalidation,systemsuitabilitytests,andqualitycontiolcheckssamples.Thesequalitycomponentsaredescribedasbelow.

在產(chǎn)生可靠和一致的數(shù)據(jù)（質(zhì)量數(shù)據(jù)的過程中涉及了四個(gè)重要的組成部分。圖1以層疊形式在質(zhì)量三角形內(nèi)展示了這些組成部分。每層相加構(gòu)成了總體質(zhì)量。分析儀器確認(rèn)構(gòu)成了產(chǎn)生質(zhì)量數(shù)據(jù)的基礎(chǔ)。作為質(zhì)量數(shù)據(jù)產(chǎn)生的基礎(chǔ)的其他組成部分為分析方法驗(yàn)證、系統(tǒng)適用性測試、質(zhì)量控制檢驗(yàn)樣品。這些質(zhì)量部分描述如下。Figure1.ComponentsofdataqualityAnalyticalIiistnunentQualification分析儀器確認(rèn)AIQisthecollectionofdocumentedevidencethatannistninientpeifbimssuitablyfbiitsintendedpuipose.Useofaqualifiednistninientinanalysescontnbutestoconfidenceinthevalidityofgenerateddata.AIQ是證明某個(gè)儀器表現(xiàn)得適合其預(yù)定用途的文件證據(jù)的匯總。在分析中使用確認(rèn)過的儀器確保了對所生成數(shù)據(jù)的有效性的信心。AnalyticalMethodValidation分析方法驗(yàn)證Analyticalmethodvalidationisthecollectionofdocumentedevidencethatananalyticalpiocedureissuitableforitsmtendeduse.Useofavalidatedprocedurewithqualifiedanalyticalmstiumentsprovidesconfidencethatthepiocedurewillgeneratetestdataofacceptablequality.AdditionalguidanceonvalidationofcompendialpioceduiesmaybefoundinthegeneralinfbimationchapterValidationofCompendialPioceduies<1225>.分析方法驗(yàn)證是某個(gè)分析方法適合其預(yù)定用途的文件證據(jù)的匯總。使用確認(rèn)過的分析儀器和驗(yàn)證過的方法確保了該方法將會(huì)產(chǎn)生質(zhì)量可接受的測試數(shù)據(jù)的信心。關(guān)于藥典方法的驗(yàn)證方法的額外指導(dǎo)原則可以在通則藥典方法的驗(yàn)證<1225>中找到。SystemSuitabilityTests系統(tǒng)適用性測試Systemsuitabilitytestsverifythatthesystemwillpeifbiminaccoidancewiththeciitenasetforthinthepiocedure.Thesetestsarepeifbimedalongwiththesampleanalysestoenstuethatthesystem'sperfbnnanceisacceptableatthetimeofthetest.USPgeneralchapterClHomatogiaphy<621>presentsamoredetaileddiscussionofsystemsuitabilitytestsasrelatedtochiomatogiaphicsystems.系統(tǒng)適用性測試證實(shí)該系統(tǒng)的表現(xiàn)將會(huì)符合此方法中設(shè)定的標(biāo)準(zhǔn)。這些測試與樣品分析儀器進(jìn)行、從而確保此系統(tǒng)的表現(xiàn)在測試的時(shí)候是可以接受的。USP通則色譜法V621>呈現(xiàn)了對于色譜系統(tǒng)的系統(tǒng)適用性測試的更加具體討論。QualityControlCheckSamples質(zhì)量控制檢驗(yàn)樣品Manyanalystscanyoutthentestsoninstnniientsstandardizedusmglefeiencematenalsand/oicalibrationstandaids.Someanalystsalsorequiretheinclusionofqualitycontrolchecksamplestoprovideanin-processorongoingassiwanceofthetest'ssuitablepeifbniiance.Inthisniamiei;AIQandanalyticalmethodvalidationcontnbutetothequalityofanalysisbeforeanalystsconductthetests.Systemsuitabilitytestsandqualitycontrolcheckshelpensurethequalityofanalyticalresultsmimediatelybefbieorduimgsampleanalysis.許多分析員在以標(biāo)準(zhǔn)物質(zhì)和/或校準(zhǔn)標(biāo)準(zhǔn)品進(jìn)行標(biāo)準(zhǔn)化的儀器上進(jìn)行他們的測試。一些分析員還要求加入質(zhì)量控制檢驗(yàn)樣品,以便對此測試的適當(dāng)表現(xiàn)提供中間或持續(xù)的保證。在這個(gè)方面,在分析員進(jìn)行該測試之前,AIQ和分析方法驗(yàn)證就對分析質(zhì)量起到了作用。系統(tǒng)適用性測試和質(zhì)量控制檢查，則在樣品分析馬上開始之前或在其過程中，幫助確保分析結(jié)果的質(zhì)量。ANALYTICALINSTRUMENTQUALIFICATIONPROCESS分析儀器確認(rèn)程序ThefollowingsectionsaddressindetailtheAIQprocess.Theotherthieecomponentsofbuildingqualityintoanalyticaldata analyticalmethodvalidation,systemsuitabilitytests,andqualitycontiolchecksamples arenotwitlrnithescopeofthischapter.下面的章節(jié)具體解答了AIQ的過程。確保分析數(shù)據(jù)質(zhì)量的其他3個(gè)組成部分，分析方法驗(yàn)證、系統(tǒng)適用性測試、質(zhì)量控制檢驗(yàn)樣品,不在此通則的范圍之內(nèi)。QualificationPhases確認(rèn)的階段Instnimentqualificationisnotasinglecontinuousprocess,butmsteadresultsfiomseveraldiscreteactivities.Forconvenience,theseactivitiescanbegroupedintofbuiphases:designqualification(DQ,installationqualification(IQ,opeiationalqualification(OQ,andpeifoimancequalification(PQ.儀器確認(rèn)不是一個(gè)單獨(dú)的連續(xù)過程、而是源自若干獨(dú)立活動(dòng)的結(jié)果。為方便起見,這些活動(dòng)可以被歸為4個(gè)階段:設(shè)計(jì)確認(rèn)(DQ、安裝確認(rèn)((IQ、運(yùn)行確認(rèn)(OQ、性能確認(rèn)(PQ。SomeAIQactivitiescovermorethanonequalificationphase,andanalystspotentiallycouldpeifbimthemduringmorethanoneofthephases(seeTable1.Howevei;inmanymstancesthereisneedfbispecificordertotheAIQactivities;fbrexample,installationqualificationmustoccurfiistinoideitoimtiateotherqualificationactivities.TheAIQactivitieswillbedefinedanddocumented.一些AIQ活動(dòng)包括了超過一個(gè)確認(rèn)階段，并且分析員傾向于可以跨階段進(jìn)行這些活動(dòng)(見表lo但是,在很多情況下、AIQ活動(dòng)有特定的順序要求;例如，安裝確認(rèn)必須首先發(fā)生.以便啟動(dòng)其他確認(rèn)活動(dòng)。AIQ活動(dòng)將被定義并以文件形式記錄。Table1.Timing,Applicability,andActivitiesfbiEachPhaseofAnalyticalInstrumentQualification*DesignQualificationListallationQualificationOperationalQualificationPeifbimanceQualificationTuningandApplicabilityPnoitopurchaseofanewmodelofmstiumentAtinstallationofeachmstiument(new,old,01existingunqualifiedAfterinstallationormajorrepairofeachinstnimentPenodicallyatspecifiedinteivalsfbieachinstnimentActivitiesAssuranceofmanufacturer^DQDescription<—―>FixedpaiainetersPreventivemaintenanceandlepansAssuranceofadequatesupponavailabilityfiommanufactuieiInstnimentdeliveiyEstablishpracticestoaddressoperation.cahbiation,maintenance,andchangecontiolInstrument'sfitnessforuseinlaboratoiyUtilities/facilityEnviionmentAssemblyandinstallationNetwoikanddatastorage<――>Securedatastorage,backup,andarchiveInstallationverification<――>InstmmentfimctiontestsPerfbimancechecks*Activitiesundereachphaseareusuallypeifbimedasgiveninthetable.Howevei;insomecases,itmaybemoieappiopnatetopeifbrmorcombineagivenactivitywithanotherphase.Suchactivities,spanningmorethanonequalificationphaseareshownascomiectedbydoubleanows.Ifanactivitylistedunderagivenphaseispeifbimedunderanotherphase,itisnotnecessaiytorepeattheactivityunderthephasewheretheactivityislisted.Peifbrmmgtheactivityisfarmorennpoitantthanthephaseunderwhichtheactivityispeifbimed.表1.分析儀器確認(rèn)每個(gè)階段的時(shí)間表、實(shí)用性、活動(dòng)設(shè)計(jì)確認(rèn)安裝確認(rèn)運(yùn)行確認(rèn)性能確認(rèn)時(shí)間表和實(shí)用性在購買新型儀器之前在安裝每個(gè)儀器時(shí)（新的、舊的、或一直未經(jīng)確認(rèn)的在每個(gè)儀器安裝或大修之后每個(gè)儀器在規(guī)定的間隔定期進(jìn)行活動(dòng)確認(rèn)制造商設(shè)計(jì)確認(rèn)描述一固定參數(shù)預(yù)防性保養(yǎng)和維修確認(rèn)制造商可以給與充分支持儀器運(yùn)送設(shè)立相關(guān)規(guī)程，以解決操作、校準(zhǔn)、維護(hù)、變更控制儀器在實(shí)驗(yàn)室中使用的適用性公用設(shè)施/設(shè)施一―>環(huán)境組裝與安裝網(wǎng)絡(luò)和數(shù)據(jù)儲(chǔ)存一—>安全的數(shù)據(jù)儲(chǔ)存、備份、存檔安裝確認(rèn)一—>儀器功能測試一性能測試在每個(gè)階段下的活動(dòng)通常按照表中列出地進(jìn)行。但是，在某些情況下,可以更加適合進(jìn)行或合并某個(gè)特定活動(dòng)于其他階段。這樣跨域超過一個(gè)確認(rèn)階段的活動(dòng)用雙箭頭連接來顯示。如果某個(gè)列出于特定階段的活動(dòng)進(jìn)行于另外一個(gè)階段，沒有必要在列出該活動(dòng)的階段重復(fù)進(jìn)行。進(jìn)行該活動(dòng)要比該活動(dòng)在那個(gè)階段進(jìn)行重要許多。DESIGNQUALIFICATION設(shè)計(jì)確認(rèn)Designqualification(DQisthedocumentedcollectionofactivitiesthatdefinethehinctionalandopeiationalspecificationsoftheinstnunentandcnteiiafortheselectionofthevendor,basedontheintendedpurposeofthemstniment.Designqualification(DQmaybepeifbimednotonlybytheinstnunentdeveloper01manufacuneibutalsomaybepeifbimedbytheuser.Themanufacuneiisgenerallylesponsiblefbirobustdesignandmamtaminginfbimationdescribinghowtheanalyticalinstnunentismanufacuiied(designspecifications,fiuictionallequHements,etc.andtestedbeforeshipmenttousers.Nonetheless,theusershouldensurethatconuneicialoff-the-shelf(COTSinstnunentaresuitablefbithenmtendedapplicationandthatthemanufactuieihasadoptedaqualitysystemthatprovidesfbireliableequipment.Usersshouldalsodeterminethemanufactiu-ei^scapabilityfbrsupportinstallation,services,andtraining.Thisdetenninationiniglitbeaidedbytheuser'spreviousinteractionwiththemanufacturer.設(shè)計(jì)確認(rèn)(DQ是基于儀器預(yù)定用途，對儀器的功能與操作標(biāo)準(zhǔn)和提供商的選取標(biāo)準(zhǔn)做出規(guī)定的活動(dòng)總匯,并以文件記錄。設(shè)計(jì)確認(rèn)(DQ不僅可以由儀器開發(fā)者或制造商進(jìn)行.也可以有使用者進(jìn)行。制造商通常負(fù)責(zé)穩(wěn)健設(shè)計(jì)和維護(hù)信息，描述該分析儀器如何制造(設(shè)計(jì)標(biāo)準(zhǔn)、功能要求等在發(fā)給客戶之前如何測試。雖然如此，使用者仍應(yīng)該確保商用成品儀器適用于他們的預(yù)定用途，并且制造商已經(jīng)采納了能夠保證儀器可靠的質(zhì)量系統(tǒng)。使用者也應(yīng)該確定制造商在輔助安裝、服務(wù)、培訓(xùn)方面的能力。確定的過程可以借助使用者以前與制造商的互動(dòng)交流。INSTALLATIONQUALIFICATION安裝確認(rèn)Installationqualification(IQisthedocumentedcollectionofactivitiesnecessaiytoestablishthatannistnnnentisdeliveredasdesignedandspecified,andispiopeilymstalleduitheselectedenvuomnent,andthatthisenvuomnentissuitablefbithemstniment.IQappliestoanmstnimentthatisneworwaspie-owned,ortoanymstmmentthatexistsonsitebuthasnotbeenpreviousqualified.RelevantpartsofIQwouldalsoapplytoaqualifiedmstmmentthathasbeentianspoitedtoanotherlocation01isbemgreinstalledfbiotherreasons,suchaspiolongedstorage.TheactivitiesanddocumentationtypicallyassociatedwithIQareasfollows.安裝確認(rèn)（IQ是對用于確定某個(gè)儀器按照設(shè)計(jì)和規(guī)定的方式運(yùn)輸并正確安裝在選定的環(huán)境中，以及該環(huán)境適合于此儀器所必需的活動(dòng)總匯.并以文件記錄。IQ應(yīng)用于某件儀器，其可以是新的或是二手的.或應(yīng)用于任何已經(jīng)在現(xiàn)場但是此前從未確認(rèn)過的儀器。IQ的相關(guān)部分也會(huì)用于某個(gè)已經(jīng)確認(rèn)的設(shè)備，但是該設(shè)備經(jīng)過運(yùn)輸至另外的一個(gè)場所或由于其他原因（例如，延長的存儲(chǔ)重新安裝。通常與IQ相關(guān)的活動(dòng)和文件如下。Descnption Provideadescriptionofthemstmment01thecollectionofmstmmentcomponents,includingitsnianufacnnei;model,serialnumbei;softwareversion,andlocation.Useofdrawingsandflowchartwhereappropriate.描述----提供該儀器或者儀器組成部分匯總的描述，包括其制造商、型號(hào)、編號(hào)、軟件版本、放置位置。適當(dāng)情況下使用圖紙和流程圖。InstillmentDeliveiy Ensurethattheinstniment,software,manuals,supplies,andanyotheruistmmentaccessoriesainveasspecifiedmthepurchaseorderandthattheyaieundamaged.Forapre-owned01existinginstnnnent.manualsanddocumentationshouldbeobtamed.儀器運(yùn)輸-----確保該儀器、軟件、手冊、供給品，以及其他儀器附件按照訂單中規(guī)定的方式抵達(dá),并且他們沒有損壞。對于二手或已有的儀器，手冊和記錄文件必須得到。Utilities/Facility/Eiivuomiient---Veufythattheinstallationsitesatisfactonlymeetsmanufactuiei-specifiedenvironmentallequuements.公用設(shè)施/設(shè)施/環(huán)境-----證實(shí)安裝區(qū)域令人滿意地達(dá)到了制造商規(guī)定的環(huán)境要求。Assemblyandmstallation----Assemblyandinstalltheinstnunent.andpeiibimanypielnmnaiydiagnosticsandtestmg.Assemblyandmstallationmaybedonebythemanufactuiei;vendor,specializedengineeis,orqualifiedin-housepeisonnel.Manufactuiei-establishedinstallationtestsandguidesprovideavaluablebaselinerefeiencefbidetermininginstnunentacceptance.Anyabnormaleventobseivedduringassemblyandinstallationmeiitsdocumenting.Installationpackagespurchasedfiomthemanufactiireiorthevendormay,however,needtobesupplementedwithuser-specificcntena.組裝和安裝---組裝和安裝儀器,并進(jìn)行任何預(yù)診斷和測試。組裝和安裝可以由其制造商、供應(yīng)商、專業(yè)工程師、或有資質(zhì)的內(nèi)部員工來進(jìn)行。對于確定儀器的驗(yàn)收，制造商確定的安裝測試和指導(dǎo)提供了具有價(jià)值的基本參考。在組裝和安裝過程中觀察到的任何異常事件均需以文件記錄。但是，購自制造商或供應(yīng)商的安裝包需要根據(jù)用戶的具體標(biāo)準(zhǔn)進(jìn)行補(bǔ)充。NetwoikandDataStorage---Someanalyticalsystemsrequiieuserstoprovidenetworkconnectionsanddatastoragecapabilitiesatthemstallationsite.Whenreqirned,comiectthenistmmenttothenetwoik,andcheckitsfunctionality.網(wǎng)絡(luò)和數(shù)據(jù)儲(chǔ)存--一些分析系統(tǒng)要求使用者在安裝場所提供網(wǎng)絡(luò)連接和數(shù)據(jù)存儲(chǔ)能力。當(dāng)需要時(shí)，將儀器連接到網(wǎng)絡(luò)，并檢查其功能。InstallationVerification----Peifoimthemitialdiagnosticsandtestingoftheuistmmentafteiinstallation.安裝認(rèn)證--在安裝之后，進(jìn)行該儀器的初始診斷和測試。OPERATIONALQUALIFICATION運(yùn)行確認(rèn)AfterasuccessfiilIQ,theinstmmentisreadyfbiOQtesting.Opeiationalqualification(OQisthedocumentedcollectionofactivitiesnecessaiytodemonstratethataninstmmentwillfiuictionaccoidmgtoitsoperationalspecificationintheselectedenvuoiiment.TestingactivitiesintheOQphaseconsistofthesetestpaiameteis.在成功的IQ之后,此儀器就可以進(jìn)行OQ測試了。操作確認(rèn)(OQ是證實(shí)某個(gè)儀器將會(huì)在選定的環(huán)境中按照其操作規(guī)范運(yùn)行所必需的活動(dòng)總匯，并以文件記錄。在OQ階段的測試活動(dòng)包含了這些測試參數(shù)。FixedPaiametei----Thesetestsmeasuretheinstrument'snon-changmgpaiameteisuchaslength,height,weight,voltageinputs,acceptablepiessuies,andloads.Ifthemanufactuiei-suppliedspecificationsfbithesepaiameteissatisfytheuser,thetestlequuementsmaybewaived.However,iftheuserwantstoconfiimthepaiameteis,testingcanbeperfbnnedattheuser'ssite.Fixedparametersdonotchangeoverthelifeoftheinstnunent,andtherefbieneverneedledeteimination.[NOTE:ThesetestscouldalsobepeiibimedduiuigtheIQphase(seeTable1;ifso,fixedpaiameteisneednotbeledeteiminedaspartofOQtestmg.]固定參數(shù)--這些測試測量該儀器的不變參數(shù)，例如長度、高度、重量、輸入電壓、可接受壓力、載荷等。如果由制造商提供的這些參數(shù)的規(guī)格令用戶滿意，可以放棄測試要求。但是,如果用戶需要確認(rèn)這些參數(shù)，可以在使用者的場地進(jìn)行測試。固定參數(shù)在儀器的壽命周期內(nèi)不會(huì)變化,并且因此不需重測?！咀⒁?這些測試還可以在IQ階段(見表1進(jìn)行;如果這樣.固定參數(shù)作為OQ測試的一部分.無需重測。】SecmeDataStorage,Backup,andAichiving——Whenapplicable,testsecuredatahandlingsuchasstorage,backup,audittiails,andarchivingattheuser'ssiteaccordingtowrittenprocedmes.安全數(shù)據(jù)存儲(chǔ)、備份、存檔--當(dāng)可行的時(shí)候，根據(jù)書面程序，在用戶的場所測試安全數(shù)據(jù)處理工作，例如存儲(chǔ)、備份、審計(jì)追蹤、存檔等。InstillmentFunctionTests Iiistiumentftuictionslequuedbytheusershouldbetestedtoverifythattheinstnimentoperatesasintendedbythemanufactuier.Manufactuiei-suppliedinfbimationisuseftilmidentifymgspecificationsfbrthesepaiametersandmdesigningteststoevaluatetheidentifiedpaiameteis.Users,01theu-qualifieddesignees,shouldpeifbrmtheseteststoverifythattheinstnimentmeetsmanufactureroruserspecificationsintheuser'senvironment.儀器功能測試----使用者要求的儀器功能應(yīng)該被測試，以確認(rèn)該儀器能夠按照制造商所預(yù)期地操作。制造商提供的信息有助于識(shí)別這些參數(shù)的規(guī)范.并幫助設(shè)計(jì)用于評估這些識(shí)別出來的參數(shù)的測試。使用者,或者他們的有資質(zhì)的設(shè)計(jì)師,應(yīng)該進(jìn)行這些測試，以便證實(shí)該儀器在使用者的環(huán)境中達(dá)到了制造商或使用者的標(biāo)準(zhǔn)。TheextentofOQtestmgthataninstninieiitundergoesdependsonitsmtendedapplications.Theiefbre,nospecificOQtestsfbranyinstnunentorapplicationareoffereduithischapter.某個(gè)儀器經(jīng)歷的OQ測試的程度取決于其預(yù)定用途。因此，在此通則中沒有為任何儀器或用途提供任何具體的OQ測試。RoutineanalyticaltestsdonotconstituteOQtesting.OQtestsarespecificallydesignedtoverifytheinstrument'soperationaccordingtospecificationsintheuser'senvHoiiment,andrepeatingthetestingatregulaiinteivalsmaynotbelequued.Howevei;whentheinstnunentundeigoesmajorrepaiis01modifications,lelevantOQand/oiPQtestsshouldberepeatedtoverifywhetheithemstiumentcontinuestooperatesatisfactonly.Ifaninstrumentismovedtoanotherlocation,anassessmentshouldbemadeofwhat,ifany,OQtestshouldberepeated.日常分析檢測不構(gòu)成OQ測試。OQ測試是特別設(shè)計(jì)，用于確認(rèn)在用戶環(huán)境中該儀器根據(jù)其規(guī)范的運(yùn)行情況，并且定且重復(fù)該測試可能沒有必要。但是，當(dāng)儀器經(jīng)歷大修或改裝時(shí)，相關(guān)的OQ和/或PQ測試應(yīng)該重復(fù)，以便確認(rèn)該儀器是否繼續(xù)令人滿意地運(yùn)轉(zhuǎn)。如果某個(gè)儀器移到另一個(gè)位置，應(yīng)該進(jìn)行一項(xiàng)評估，以確定什么0Q測試應(yīng)該被重復(fù)（如果確實(shí)有的話。OQtestscanbemodular01holistic.Modulaitestmgofindividualcomponentsofasystemmayfacilitateinterchangingofsuchcomponentswithoutlequalification.Holistictests,wheninvolvetheentiresystem,arealsoacceptable.OQ測試可以為模塊式或整體式。系統(tǒng)中的單個(gè)組成部分的模塊式測試可以方便這樣的組成部分的交換，而無需重新確認(rèn)。設(shè)計(jì)整個(gè)系統(tǒng)的整體式測試也是可以接受的。PERFORMANCEQUALIFICATION性能確認(rèn)Peifbimancequalification(PQisthedocumentedcollectionofactivitiesnecessaiytodemonstiatethatanmstmmentconsistentlypeifbimsaccordmgtothespecificationsdefinedbytheusei;andisappropriatefbithemtendeduse.AfterIQandOQhavebeenperfbimed,theinstrument'scontmuedsuitabilityforitsintendeduseisdemonstiatedthroughpeifbimancequalification.ThePQphasemayincludethefollowingpaiameteis.性能確認(rèn)(PQ是證實(shí)某個(gè)儀器持續(xù)地按照由用戶定義的規(guī)范運(yùn)行，并適合其預(yù)定用途的活動(dòng)總匯.并以文件記錄。在IQ和OQ已經(jīng)執(zhí)行之后，該儀器對其預(yù)定用途的持續(xù)適用性通過性能確認(rèn)來證實(shí)。此PQ階段可以包括下列參數(shù)。PeifbimanceChecks----Setupatest01senesofteststovenfytheacceptablepeifbimanceofthemstnimentfbiitsmtendeduse.PQtestsareusuallybasedontheinstrument'stypicalon-siteapplicationsandmayconsistofanalyzingknowncomponentsorstandards.Thetestsshouldbebasedongoodscienceandreflectthegeneialintendeduseofthemstniment.Somesystemsuitabilitytests01qualitycontiolchecksthatarepeifbimedconcunentlywiththetestsamplescanbeusedtodemonstiatethatthemstnimentispeifoimingsuitably.PQtestsmayresemblethosepeifbimedduiingOQ,butthespecificationsfbithenresultsmaybesetdiffeientlyifrequued.Neveitheless,userspecificationsfbiPQtestsshoulddemonstratetrouble-fieemstnimentopeiationfbrtheintendedapplications.AsisthecasewithOQtesting,PQtestsmaybemodular01holistic.性能檢查----設(shè)立一個(gè)或一系列測試，以確認(rèn)具有滿足其預(yù)定用途的表現(xiàn)。PQ測試通?；趦x器常見的現(xiàn)場用途并且可以包含分析已知組分或標(biāo)準(zhǔn)物。該測試應(yīng)該具備良好的科學(xué)基礎(chǔ)并反映該儀器的一般用途。與供試樣品同步進(jìn)行的一些系統(tǒng)適用性測試或者質(zhì)量控制檢查可以用于證實(shí)該儀器正在適當(dāng)?shù)剡\(yùn)行。PQ測試可以模擬在0Q中進(jìn)行的那些測試,但是如果需要，其結(jié)果的質(zhì)量標(biāo)準(zhǔn)可以設(shè)定得不同。盡管如此，使用者對于PQ測試的標(biāo)準(zhǔn)應(yīng)該證實(shí)儀器在其用途上的無故障運(yùn)行。如同0Q測試一樣,PQ測試可以為模塊式或整體式。Testingfiequentlydependsontheniggednessofthemstnimentandthecriticalityofthetestspeiformed.Testingmaybeunscheduled----fbiexample,eachtunethemstnimentisused.Itmaybealsoscheduledfbiregiilaimteivals.Experiencewiththemstnimentcanmfluencethisdecision.ItmaybeusefilltorepeatthesamePQtestseachtimetheinstillmentisusedsothataliistoiyoftheinstrument'sperfbnnancecanbecompiled.Alteinatively,themstnimentmaybeincoipoiatedintoanintegiatedsupponsystemtoassurethatitlemauiscontinuallyqualified.Somesystemsuitabilitytests01qualitycontiolchecksthatarepeifbnnedconcunentlywiththetestsamplesalsoimplythatthemstnimentispeifbniiuigsuitably.測試的頻率取決于該儀器的耐用性和利用其所做檢驗(yàn)的重要性。測試可以是不定時(shí)的--例如該儀器每次使用的時(shí)候。它也可以在相同間隔下定時(shí)進(jìn)行。使用該儀器的體驗(yàn)可以影響這個(gè)決定。最好每次使用儀器時(shí)重復(fù)同樣PQ測試，以便能夠匯編該儀器表現(xiàn)的歷史數(shù)據(jù)。兩個(gè)方法中的另外一個(gè)是,該儀器可以整合到一個(gè)整體輔助系統(tǒng)，以便確保其持續(xù)保持已確認(rèn)的狀態(tài)。與供試樣品同步進(jìn)行的一些系統(tǒng)適用性測試或質(zhì)量控制檢查也會(huì)說明該儀器正在適當(dāng)?shù)剡\(yùn)行。PieventiveMaintenanceandRepairs----WhenaninstnunentfailstomeetPQtestspecifications,itrequuesmaintenance01lepau.Aperiodicpreventivemaintenancemayalsoberecoiiunendedfbimanynistniments.ThelelevantPQtest(sshouldberepeatedaftertheneededmaintenanceorrepautoensurethatthemstnimentlemainsqualified.預(yù)防性維護(hù)和修理---當(dāng)某個(gè)儀器未能達(dá)到PQ測試標(biāo)準(zhǔn),則該儀器需要維護(hù)或修理。還建議對許多儀器進(jìn)行定期預(yù)防性維護(hù)。在需要的維護(hù)或修理之后,應(yīng)該重復(fù)相關(guān)的一個(gè)或多個(gè)PQ測試，以確保該儀器保持合格狀態(tài)。PracticesfbiOperation.Calibration,Maintenance,andChangeContiol----Establishpracticestomaintainandcalibratethemstniment.Eachmamtenanceandcalibrationactivityshouldbedocumented.J運(yùn)行、校準(zhǔn)、維護(hù)、變更控制的操作規(guī)范--建立維護(hù)和校準(zhǔn)儀器的操作規(guī)范。每次維護(hù)和校準(zhǔn)活動(dòng)均應(yīng)以文件記錄。ROLESANDRESPONSIBILITIES角色與職責(zé)Useis使用者Usersareultimatelyresponsiblefbiinstillmentoperationsanddataquality.Theuser'sgroupencompassesanalyst,theii,supervisor,instmmentspecialists,andorganizationmanagement.Usersshouldbeadequatelytrainedintheinstrument'suse,andthentiamingrecoidsshouldbemaintainedaslequiiedbytheregulations.使用者最終負(fù)責(zé)儀器的操作和數(shù)據(jù)質(zhì)量。使用者團(tuán)隊(duì)包括分析員、其監(jiān)督者、儀器專家、機(jī)構(gòu)管理層。使用者應(yīng)該就儀器使用接受充分的培訓(xùn)，并且他們的培訓(xùn)記錄應(yīng)該按照法規(guī)要求進(jìn)行存檔。Usersshouldalsoberesponsiblefbiqualifymgtheninstnuiientsbecausethentiamingandexpemseintheuseofinstnniientsmakethemthebest-qualifiedgrouptodesignthemstnimenttest(sandspecification(snecessaiyfbisuccessftilAIQ.Consultants,equipmentnianufactuiei01vendois,validationspecialists,andqualityassurance(QApeisomielcanadviseandassistasneeded,butthefinallesponsibilitvfbiqualifyingmstmmentslieswiththeusers.TheusersmustalsomaintaintheinstmmentinaqualifiedstatebyloutmelypeifbimingPQ.使用者還應(yīng)該負(fù)責(zé)確認(rèn)儀器，因?yàn)樗麄冊趦x器使用方面接受的培訓(xùn)和專業(yè)知識(shí)，使得他們成為在設(shè)計(jì)成功的AIQ所必需的儀器測試和質(zhì)量標(biāo)準(zhǔn)方面最具資質(zhì)的團(tuán)隊(duì)。顧問、設(shè)備制造商或提供商、驗(yàn)證專家、質(zhì)量保證(QA人員可以在需要時(shí)建議并協(xié)助，但是確認(rèn)儀器的最終責(zé)任落在使用者身上。使用者還必須通過進(jìn)行日常PQ.來使該儀器保持在合格的狀態(tài)。QualityUnit質(zhì)量部門TheroleoftheQualityUmt111AIQlemainsthesameasfbianyotherregulatedactivity.QualitypeisomielareresponsiblefbiassuringthattheAIQprocessmeetscompliancelequHements,thatprocessesaiebeingfollowed,andthattheintendeduseoftheequipmentissupportedbyvalidanddocumenteddata.質(zhì)量部門在AIQ中的角色與在任何其他監(jiān)管活動(dòng)中相同。質(zhì)量員工負(fù)責(zé)確保AIQ程序達(dá)到符合性要求，程序被遵照執(zhí)行,并且儀器的預(yù)定用途被有效的且以文件記錄的數(shù)據(jù)所支持。Manufacturers制造商ManufactuieisanddevelopersareresponsiblefbiDQwhendesigningtheuistniment.Theyarealsoresponsiblefbivalidationoflelevantprocessesusedinmanufactuimgandassemblyoftheinstnnnent.Manufactuieisshouldtesttheassembledmstmmentsbefbieshippingthemtousers.制造商和開發(fā)商負(fù)責(zé)在設(shè)計(jì)該儀器時(shí)的DQ。他們還要負(fù)責(zé)對執(zhí)照和組裝該儀器中所用的相關(guān)工藝進(jìn)行驗(yàn)證。在發(fā)貨給用戶之前,制造商應(yīng)該測試組裝好的儀器。Finally,itisdesirablethatmanufacuifeisandvendorsshouldnotifyallknownusersabouthardwaredefectsdiscoveredafteraproduct'srelease;offerusertiauung,seivice,iepau\andinstallationsupport;andinviteuserauditsasnecessaiy.最終，最好制造商和供應(yīng)商應(yīng)該通知所有已知用戶,關(guān)于某個(gè)產(chǎn)品放行之后發(fā)現(xiàn)的硬件缺陷;提供用戶培訓(xùn)、服務(wù)、修理、安裝支持;并在需要時(shí)邀請用戶進(jìn)行審計(jì)。SOFTWAREVALIDATION軟件驗(yàn)證Softwareusedfbianalyticalworkcanbeclassifiedmtotlueecategories:fiimwaie;uistnimeiitcontioLdataacquisition,andprocessingsoftware;andstand-alonesoftware.Althoughsoftwarevalidationisnotthepiunaiyfocusoftluschapter,thefollowingsectionsdescribeinwhichcasestinsactivityisunderthescopeoftheanalyticalmstmmentqualification.用于分析工作的軟件可以分為三類:固件;儀器控制、數(shù)據(jù)獲取、處理軟甲;和獨(dú)立軟件。盡管軟件驗(yàn)證不是此通則的主要關(guān)注點(diǎn)，下面的部分仍然描述了在什么情況下這些活動(dòng)處于分析儀器確認(rèn)的范疇內(nèi)。Finnwaie固件Computeiizedanalyticaluistiunieiitscontamintegiatedchipswithlow-levelsoftwaie(fiimwaie.Suchmstmmentswillnothinctionwithoutpiopeilyopeiatingfinnwaie,andusersgeneiallycaimotalterfiimwaiedesign01fiinction.Fumwaieistheiefbieconsideredacomponentoftheinstnnnentitself.Indeed,thequalificationofhardwareisnotpossiblewithoutopeiatmgitviaitsfiimwaie.Thus,whenthehaidware(thatis,theanalyticalinstillmentisqualifiedattheuser'ssite,theintegratedfiimwareisalsoessentiallyqualified.Noseparateon-sitequalificationofthefiimwaieisneeded.Wheneveipossible,thefiimwaieveisionshouldbelecoidedaspartoftheIQactivities.Aliychangesmadetofiimwaieversionsshouldbehackedtluoughchangecontroloftheinstmment（seeChangeContiol,below計(jì)算機(jī)化的分析儀器包含帶低層次軟件（固件的整合芯片。不正確操作固件，這樣的儀器將無法運(yùn)行，并且使用者通常不能改變固件的設(shè)計(jì)或功能。固件因此被認(rèn)為該儀器的一個(gè)組成部分。實(shí)際上，不通過其固件操作該儀器、硬件的確認(rèn)就沒有可能。因此,當(dāng)硬件（即分析儀器在使用者的場所確認(rèn)時(shí),整合的固件實(shí)質(zhì)上也就確認(rèn)了。單獨(dú)的固件現(xiàn)場確認(rèn)是不需要的。只要可能，無論何時(shí).固件的版本應(yīng)當(dāng)被記錄為IQ活動(dòng)的一部分。對固件版本的任何變更都應(yīng)該通過該儀器的變更控制程序進(jìn)行追蹤（見下面的變更控制InstnimentControl,DataAcquisition,andProcessingSoftwaie儀器控制、數(shù)據(jù)獲取、和處理軟件Softwarefbimstimnentcontrol,dataacquisition,andprocessuigfbrmanyoftoday'scomputerizedinstillmentsisloadedouacomputerconnectedtotheinstmment.Opeiationofthemstnnnentisthencontiolledviathesoftwaie,leavingfeweroperatingcontrolsontheinstnunent.Also,thesoftwaieisneededfbidataacquisitionandpostacquisitioncalculations.Thus,bothliaidwaieandsoftwaie,thenftinctionsinextiicablyuitemvnied,aiecriticaltoprovidinganalyticalresults.在今日許多計(jì)算機(jī)化的儀器中用于儀器控制、數(shù)據(jù)獲取、處理的軟件是安裝在連接到儀器的電腦上。然后通過該軟件操作儀器，在儀器上沒有留下什么操作控制。該軟件還用于數(shù)據(jù)獲取和獲取后的計(jì)算。因此，不論軟件還是硬件，它們的功能已經(jīng)糾纏在一起無法分開，對于提供分析結(jié)果均非常關(guān)鍵。ThemanufactuieishouldperformDQ,validatethissoftwaie,andprovideuserswithasunuiiai-yofvalidation.Attheusersite,holisticqualification,whichinvolvestheentiremstnnnentandsoftwaiesystem,ismoreefficientthanmodularvalidationofthesoftwaiealone.Thus,theuserqualifiestheinstnimentcontioLdataacquisition,andprocessingsoftwaiebyqualifymgthemstiumentaccordingtotheAIQprocess.制造商應(yīng)該執(zhí)行DQ,驗(yàn)證此軟件,并且為使用者提供一份驗(yàn)證總結(jié)。在使用者的場所，整體驗(yàn)證，其涉及整個(gè)儀器和軟件系統(tǒng),比軟件單獨(dú)的模塊驗(yàn)證更有效率。因此，使用者通過根據(jù)AIQ程序確認(rèn)該儀器的方法，來確認(rèn)儀器控制、數(shù)據(jù)獲取、和處理軟件。Stand-AloneSoftware獨(dú)立軟件Ailauthontativeguidefbrvalidatmgstand-alonesoftware,suchasLIMS,isavailable.1Thevalidationprocessisadmimsteiedbythesoftwaredevelopei;who1GeneralPrincipleofSoftwareValidation:FinalGuidancefbiIndustiyandFDAStaff,U.SDepaitmentofHealthandHumanServices,FoodandDingAdmuiistiation,Rockville,MD,January11,2002.http://www.fda.otg/cdjLh/conip/guidaiice/938.htinl(accessedSeptembei2004軟件驗(yàn)證的基本準(zhǔn)則:行業(yè)與FDA員工的最終指導(dǎo)方針，美國衛(wèi)生與人類服務(wù)部、食品與藥品管理局,Rockville,MD,2002年1月11日，網(wǎng)址：http://www.fda.oig/cdih/comp/guidance/938.html(2004年9月登錄alsospecifiesthedevelopmentmodelappiopnatefbrthesoftware.Validationtakesplaceinaseriesofactivitiesplannedandexecutedthroughvariousstagesofthedevelopmentcycle.現(xiàn)在有了用于驗(yàn)證獨(dú)立軟件(例如LIMS的權(quán)威指導(dǎo)方針。驗(yàn)證程序有軟件研發(fā)者管理,其還詳細(xì)規(guī)定了適合該軟件的研發(fā)模型。驗(yàn)證發(fā)生在通過研發(fā)周期的多個(gè)階段來計(jì)劃與執(zhí)行的一系列活動(dòng)中。CHANGCONTROL變更控制Changestoinstillments,mcludingsoftwaie,becomeinevitableasmanufactuieisaddnewfeaturesandconectknowndefects.However,nnplementmgallsuchchangesmaynotalwaysbenefitusers.Usersshouldtheiefbieadoptchangestheydeemuseftil01necessaiyandshouldalsoassesstheeffectsofchangestodeterminewhat,ifany,requalificationislequiied.Thechangecontrolprocessenablesthemtodothis.當(dāng)制造商增加新功能并更正已知缺陷,對儀器的變更，包括軟件，成為無可避免的事情。但是,落實(shí)所有這些變更可能不會(huì)總是令使用者獲益。因此，使用者應(yīng)該采納他們認(rèn)為有用或必須的變更，并且還應(yīng)該評價(jià)變更的效果，以確定是否需要以及需要什么樣的再確認(rèn)。變更控制程序令他們可以做這些工作。ChangecontiolmayfollowtheDQ/IQ/OQ.PQclassificationprocess.ForDQ,evaluatethechangedpaiameters,anddeteiminewhetherneedfbfthechangewanantsunplementmgit.Ifunplementationofthechangeisneeded,installthechangestothesystemduringIQ.EvaluatewhichoftheexistingOQandPQtestsneedrevision,deletion,01addition,asaresultoftheinstalledchange.Wherethechangecallsfbiadditions,deletions,oirevisionstotheOQ01PQtests,followthepioceduieoutlinedbelow.變更控制可以遵照DQ/IQ/OQ/PQ分級(jí)程序。對于DQ,評價(jià)變更的參數(shù),并確定對變更的需要是否能使執(zhí)行該變更有正當(dāng)理由。如果該變更的執(zhí)行是需要的，在IQ過程中對系統(tǒng)執(zhí)行該變更。評價(jià)現(xiàn)存的0Q和PQ測試中那些需要修改、刪除、或增加.作為已執(zhí)行變更的結(jié)果。當(dāng)變更要求對0Q或PQ測試進(jìn)行增加、刪除、或更改時(shí)，遵照下面列出的程序。OperationalQualification---