who驗(yàn)證指南2016年版

1、INTRODUCTION簡(jiǎn)介Validationisanessentialpartofgoodpracticesincludinggoodmanufacturingpractices(GMP)(4)andgoodclinicalpractices(GCP).Itisthereforeanelementofthepharmaceuticalqualitysystem.Validation,asaconcept,incorporatesqualificationandshouldbeappliedoverthelifecycleof,e.g.theapplicableproduct,process

2、,system,equipmentorutility.驗(yàn)證是包括GMP和GCP在內(nèi)的良好規(guī)范的必要部分。因此是制藥質(zhì)量體系的組成部分。驗(yàn)證這個(gè)概念包括確認(rèn)并且應(yīng)該在產(chǎn)品、工藝、系統(tǒng)、設(shè)備或設(shè)施的整個(gè)生命周期中被使用。Theseguidelinescoverthegeneralprinciplesofvalidationandqualification.Inadditiontothemainpart,appendicesonvalidationandqualification(e.g.cleaning,computerandcomputerizedsystems,equipment,utilit

3、iesandsystems,andanalyticalmethods)areincluded.這個(gè)指南包括驗(yàn)證和確認(rèn)的一般原則。除了主體部分外，還包括確認(rèn)和驗(yàn)證附件(如清潔、計(jì)算機(jī)和計(jì)算機(jī)化系統(tǒng)、設(shè)備、設(shè)施和系統(tǒng)以及分析方法。Thefollowingprinciplesapply:適用的原則如下：theexecutionofvalidationshouldbeincompliancewithregulatoryexpectations;驗(yàn)證的執(zhí)行應(yīng)該符合監(jiān)管預(yù)期quality,safetyandefficacymustbedesignedandbuiltintotheproduct;質(zhì)量、安全

4、和效力應(yīng)該被設(shè)計(jì)和構(gòu)建到產(chǎn)品中qualitycannotbeinspectedortestedintotheproduct;質(zhì)量不能通過檢查或測(cè)試賦予產(chǎn)品qualityriskmanagementprinciplesshouldbeappliedindeterminingtheneed,scopeandextentofvalidation;應(yīng)該應(yīng)用質(zhì)量風(fēng)險(xiǎn)管理規(guī)則來決定驗(yàn)證的需求、范圍和程度ongoingreviewshouldtakeplacetoensurethatthevalidatedstateismaintainedandopportunitiesforcontinuingimpro

5、vementareidentified.應(yīng)該進(jìn)行持續(xù)的回顧來確保維持驗(yàn)證狀態(tài)并識(shí)別持續(xù)改進(jìn)的機(jī)會(huì)Theimplementationofvalidationworkrequiresconsiderableresourcessuchas:驗(yàn)證工作的完成需要大量資源，例如time:generallyvalidationworkissubjecttorigoroustimeschedules;時(shí)間：一般驗(yàn)證工作需要有一個(gè)嚴(yán)密的時(shí)間表financial:validationoftenrequiresthetimeofspecializedpersonnelandexpensivetechnology.資

6、金：驗(yàn)證經(jīng)常需要專業(yè)人員和昂貴的技術(shù)human:validationrequiresthecollaborationofexpertsfromvariousdisciplines(e.g.amultidisciplinaryteam,comprisingqualityassurance,engineering,informationtechnology,manufacturingandotherdisciplines,asappropriate.).人員：驗(yàn)證需要不同學(xué)科專家的協(xié)作(例如一個(gè)多學(xué)科小組，視情況可能包括QA、工程、信息技術(shù)、生產(chǎn)以及其他學(xué)科人員)SCOPE范圍Theseguide

7、linesfocusmainlyontheoverallconceptofvalidationandarenotintendedtobeprescriptiveinspecificvalidationrequirements.Thisdocumentservesasgeneralguidanceonlyandtheprinciplesmaybeconsideredusefulinitsapplicationinthemanufactureandcontrolofstartingmaterialsandfinishedpharmaceuticalproducts(FPPs),aswellasot

8、herareas.Validationofspecificprocessesandsystems,forexample,insterileproductmanufacture,requiresmuchmoreconsiderationandadetailedapproachthatisbeyondthescopeofthisdocument.這些指南主要關(guān)注驗(yàn)證的整體概念，無意規(guī)定具體的驗(yàn)證要求。用作GMP檢查官和生產(chǎn)商的基本指南，本文件僅作為一個(gè)一般指南，其原則在其應(yīng)用于起始物料及制劑的生產(chǎn)和控制時(shí)會(huì)比較有用，也應(yīng)用于其他領(lǐng)域。特定工藝和產(chǎn)品的驗(yàn)證，例如無菌產(chǎn)品生產(chǎn)，需要考慮更多內(nèi)容，和更詳

9、細(xì)的方法，不在本文件范圍之內(nèi)。Therearemanyfactorsaffectingthedifferenttypesofvalidationanditis,therefore,notintendedtodefineandaddressallaspectsrelatedtooneparticulartypeofvalidationhere.有很多因素會(huì)對(duì)不同類型的驗(yàn)證產(chǎn)生影響，因此，這里不會(huì)對(duì)某個(gè)特定類型的驗(yàn)證相關(guān)的所有方面進(jìn)行定義和說明。Thegeneraltextinthemainpartoftheseguidelinesmaybeapplicabletovalidationandqua

10、lificationofpremises,equipment,utilities,systems,processesandprocedures.這些指南的主體部分的一般內(nèi)容可能適用于設(shè)施、設(shè)備、公用設(shè)施和系統(tǒng)、工藝和程序的驗(yàn)證和確認(rèn)。GLOSSARY術(shù)語Thedefinitionsgivenbelowapplytothetermsusedintheseguidelines.Theymayhavedifferentmeaningsinothercontexts.本指南使用的術(shù)語定義如下。它們?cè)谄渌h(huán)境中可能有不同的含義calibration.Thesetofoperationsthatestab

11、lish,underspecifiedconditions,therelationshipbetweenvaluesindicatedbyaninstrumentorsystemformeasuring(forexample,weight,temperatureandpH),recording,andcontrolling,orthevaluesrepresentedbyamaterialmeasure,andthecorrespondingknownvaluesofareferencestandard.Limitsforacceptanceoftheresultsofmeasuringsho

12、uldbeestablished.校準(zhǔn)：changecontrol(includingchangemanagement).Aformalsystembywhichqualifiedrepresentativesofappropriatedisciplinesreviewproposedoractualchangesthatmightaffectavalidatedstatus.Theintentistodeterminetheneedforactionthatwouldensurethatthesystemismaintainedinavalidatedstate(referenceworki

13、ngdocumentQAS/15.639/Rev.1-unpublished).變更控制(包括變更管理)cleaningvalidation.Documentedevidencetoestablishthatcleaningproceduresareremovingresiduestopredeterminedlevelsofacceptability,takingintoconsiderationfactorssuchasbatchsize,dosing,toxicologyandequipmentsize.清潔驗(yàn)證commissioning.Thesettingup,adjustmenta

14、ndtestingofequipmentorasystemtoensurethatitmeetsalltherequirements,asspecifiedintheuserrequirementspecification,andcapacitiesasspecifiedbythedesignerordeveloper.Commissioningiscarriedoutbeforequalificationandvalidation.試車computervalidation(includingcomputerizedsystemvalidation).Confirmationbyexamina

15、tionandprovisionofobjectivedocumentedevidencethatcomputerizedsystemspecificationsconformtouserneedsandintendeduses,andthatallrequirementscanbeconsistentlyfulfilled.計(jì)算機(jī)驗(yàn)證(包括計(jì)算機(jī)化系統(tǒng)驗(yàn)證)concurrentvalidation.Validationcarriedoutduringroutineproductionofproductsintendedforsale.同步驗(yàn)證designqualification.Docum

16、entedverificationthattheproposeddesignoffacilities,systemsandequipmentissuitablefortheintendedpurpose.設(shè)計(jì)確認(rèn)goodengineeringpractices.Establishedengineeringmethodsandstandardsthatareappliedthroughouttheprojectlife-cycletodeliverappropriate,cost-effectivesolutions.良好工程規(guī)范installationqualification.Documen

17、tedverificationthattheinstallations(suchasmachines,computersystemcomponents,measuringdevices,utilitiesandmanufacturingareas)usedinaprocessorsystemareappropriatelyselectedandcorrectlyinstalledinaccordancewithestablishedspecifications.安裝確認(rèn)operationalqualification.Documentedverificationthatthesystemors

18、ubsystemoperatesasintendedoverallanticipatedoperatingranges.運(yùn)行確認(rèn)performancequalification.Documentedverificationthattheequipmentorsystemperformsconsistentlyandreproduciblywithindefinedspecificationsandparametersinitsnormaloperatingenvironment(heproductionenvironment).(Inthecontextofsystems,theterm“pr

19、ocessvalidation”mayalsobeused.)性能確認(rèn)processvalidation.Thecollectionandevaluationofdata,throughouttheproductlifecycle,whichprovidesdocumentedscientificevidencethataprocessiscapableofconsistentlydeliveringqualityproducts.工藝驗(yàn)證prospectivevalidation.Validationcarriedoutduringthedevelopmentstageonthebasiso

20、fariskanalysisoftheproductionprocess,whichisbrokendownintoindividualsteps;thesearethenevaluatedonthebasisofpastexperiencetodeterminewhethertheymayleadtocriticalsituations.前驗(yàn)證qualification.Documentedevidencethatpremises,systemsorequipmentareabletoachievethepredeterminedspecificationsproperlyinstalled

21、,and/orworkcorrectlyandleadtotheexpectedresults.Qualificationisoftenapart(theinitialstage)ofvalidation,buttheindividualqualificationstepsalonedonotconstituteprocessvalidation.確認(rèn)revalidation.Repeatedvalidationofapreviouslyvalidatedsystem(orapartthereof)toensurecontinuedcompliancewithestablishedrequir

22、ements.再驗(yàn)證：對(duì)先前已驗(yàn)證的系統(tǒng)(或它的一部分)的重復(fù)驗(yàn)證來確保持續(xù)符合既定標(biāo)準(zhǔn)。standardoperatingprocedure.Anauthorizedwrittenproceduregivinginstructionsforperformingoperationsnotnecessarilyspecifictoagivenproductormaterialbutofamoregeneralnature(e.g.equipmentoperation,maintenanceandcleaning;validation;cleaningofpremisesandenvironmen

23、talcontrol;samplingandinspection).Certainstandardoperatingproceduresmaybeusedtosupplementproduct-specificmasterbatchproductiondocumentation.標(biāo)準(zhǔn)操作規(guī)程validation.Actionofprovinganddocumentingthatanyprocess,procedureormethodactuallyandconsistentlyleadstotheexpectedresults.驗(yàn)證validationmasterplan.Thevalidat

24、ionmasterplanisahigh-leveldocumentthatestablishesanumbrellavalidationplanfortheentireprojectandsummarizesthemanufacturersoverallphilosophyandapproach,tobeusedforestablishingperformanceadequacy.Itprovidesinformationonthemanufacturersvalidationworkprogrammeanddefinesdetailsofandtimescalesforthevalidat

25、ionworktobeperformed,includingastatementoftheresponsibilitiesofthoseimplementingtheplan.驗(yàn)證主計(jì)劃validationprotocol.Adocumentdescribingtheactivitiestobeperformedduringavalidation,includingtheacceptancecriteriafortheapprovalofaprocessorsystemorapartthereofforintendeduse.驗(yàn)證方案validationreport.Adocumentinwh

26、ichtherecords,resultsandevaluationofvalidationareassembledandsummarized.Itmayalsocontainproposalsfortheimprovementofprocessesand/orsystemsand/orequipment.驗(yàn)證報(bào)告verification.Theapplicationofmethods,procedures,testsandotherevaluations,inadditiontomonitoring,todeterminecompliancewithestablishedrequiremen

27、tsandspecifications.核實(shí)worstcase.Aconditionorsetofconditionsencompassingtheupperandlowerprocessinglimitsforoperatingparametersandcircumstances,withinSOPs,whichposethegreatestchanceofproductorprocessfailurewhencomparedtoidealconditions.Suchconditionsdonotnecessarilyincludeproductorprocessfailure.最差條件R

28、ELATIONSHIPBETWEENVALIDATIONANDQUALIFICATION驗(yàn)證與確認(rèn)的關(guān)系Qualificationandvalidationareessentiallythesame.Thetermqualificationisnormallyusedforequipmentandutilities,andvalidationforsystemsandprocesses.Inthissense,qualificationcanbeseenaspartofvalidation.確認(rèn)和驗(yàn)證本質(zhì)上是一樣的。確認(rèn)通常用于設(shè)備和設(shè)施，而驗(yàn)證則用于系統(tǒng)和工藝。在這層意義上，確認(rèn)可以被看做是

29、驗(yàn)證的一部分。Wheretheterm“validation”isusedinthedocument,thesameprinciplesmaybeapplicablefor“qualification在文件中使用術(shù)語“驗(yàn)證”的規(guī)則同樣適用于“確認(rèn)”VALIDATION驗(yàn)證Approachestovalidation驗(yàn)證的方法Manufacturersshouldorganizeandplanvalidationinamannerthatwillensureproductquality,safetyandefficacythroughoutitslifecycle.生產(chǎn)商應(yīng)該組織和計(jì)劃驗(yàn)證以保證

30、產(chǎn)品在其生命周期內(nèi)的質(zhì)量、安全和有效。Thescopeandextentofqualificationandvalidationshouldbebasedonriskmanagementprinciples.確認(rèn)和驗(yàn)證的范圍和程度應(yīng)該基于風(fēng)險(xiǎn)管理規(guī)則。Statisticalcalculationsshouldbeapplied,whereappropriate,andprovidescientificevidencethattheprocess,systemorotherrelatedaspectisappropriatelyvalidated.適當(dāng)時(shí)，應(yīng)該使用統(tǒng)計(jì)學(xué)計(jì)算并提供工藝、系統(tǒng)或其它

31、相關(guān)方面有效的科學(xué)證據(jù)Qualificationandvalidationshouldbedoneinaccordancewithpredeterminedprotocols,andtheresultsappropriatelydocumented,e.g.inreports.確認(rèn)和驗(yàn)證應(yīng)該按照預(yù)定的方案執(zhí)行并且結(jié)果應(yīng)被適當(dāng)?shù)挠涗?，如在?bào)告中。Thereshouldbeanappropriateandeffectivequalitysystemensuringtheorganizationandmanagementofvalidation.應(yīng)有適當(dāng)?shù)暮陀行У馁|(zhì)量體系來保證驗(yàn)證的組織和管理。Se

32、niormanagementshouldensurethattherearesufficientresourcestoperformvalidationinatimelymanner.Managementandpersonsresponsibleforqualityassuranceshouldbeactivelyinvolvedintheprocessandauthorizationofprotocolsandreports.高級(jí)管理層應(yīng)該確保充分的資源來及時(shí)地執(zhí)行驗(yàn)證。管理層和質(zhì)量保證負(fù)責(zé)人應(yīng)該積極參與方案和報(bào)告的批準(zhǔn)活動(dòng)中。Personnelwithappropriatequalific

33、ationandexperienceshouldberesponsibleforperformingvalidation.有適當(dāng)資質(zhì)和經(jīng)驗(yàn)的人員應(yīng)該對(duì)驗(yàn)證的執(zhí)行負(fù)責(zé)。Thereshouldbeaspecificprogrammeorscheduletosupportplanningandexecutionofvalidationactivities.應(yīng)有專門的計(jì)劃或時(shí)間表來支持計(jì)劃和執(zhí)行驗(yàn)證活動(dòng)。Validationshouldbeperformedinastructuredwayaccordingtothedocumentedprotocolsandprocedures.驗(yàn)證應(yīng)該按照文件化的

34、方案和規(guī)程以一種有組織的方式執(zhí)行。Qualificationandvalidationshouldbeperformed:確認(rèn)和驗(yàn)證應(yīng)該被執(zhí)行：-fornewpremises,equipment,utilitiesandsystems,andprocessesandprocedures;新設(shè)施、設(shè)備、公用設(shè)施和系統(tǒng)，以及新的工藝和程序；-whenchangesaremade,dependingontheoutcomeofriskassessment;當(dāng)發(fā)生變更時(shí)，根據(jù)風(fēng)險(xiǎn)評(píng)估的結(jié)果；-wherenecessaryorindicatedbasedontheoutcomeofperiodicrev

35、iew.基于定期回顧的結(jié)果表明需要的5.11Awrittenreportontheoutcomeofthevalidationshouldbeprepared.應(yīng)該對(duì)驗(yàn)證的結(jié)果準(zhǔn)備一份書面報(bào)告。5.12Thescopeandextentofvalidationshouldbebasedonknowledgeandexperience,andtheoutcomeofqualityriskmanagementprinciplesasdescribedintheWorldHealthOrganization(WHO)guidelinesonqualityriskmanagement.Wherenec

36、essaryworst-casesituationsorspecificchallengetestsshouldbeconsideredforinclusioninthevalidation,forexample,stressloadandvolumeverificationincomputersystemvalidation.驗(yàn)證的范圍和程度應(yīng)該基于知識(shí)和經(jīng)驗(yàn)，以及描述于WHO質(zhì)量風(fēng)險(xiǎn)管理指南中的質(zhì)量風(fēng)險(xiǎn)管理管理規(guī)則的結(jié)果來決定。DOCUMENTATION文件-Qualificationandvalidationshouldbedoneaccordingtowrittenprocedures

37、.確認(rèn)和驗(yàn)證應(yīng)該按照書面程序執(zhí)行6.2Documentsassociatedwithqualificationandvalidationinclude:與確認(rèn)和驗(yàn)證相關(guān)的文件包括：-validationmasterplan(VMP);驗(yàn)證主計(jì)劃(VMP)-standardoperatingprocedures(SOPs);標(biāo)準(zhǔn)操作規(guī)程(SOP)specifications;規(guī)范protocolsandreports;方案和報(bào)告riskassessmentoutcomes;風(fēng)險(xiǎn)管理結(jié)果processflowcharts;工藝流程圖operatormanuals;操作手冊(cè)trainingrecor

38、ds;培訓(xùn)記錄calibrationproceduresandrecords;校準(zhǔn)規(guī)程和記錄samplingplans;取樣計(jì)劃testingplansandmethods;測(cè)試計(jì)劃和方法statisticalmethodsandresults;統(tǒng)計(jì)學(xué)方法和結(jié)果historyofqualificationorvalidation;確認(rèn)或驗(yàn)證歷史planforensuringreviewofvalidationstatus;確?；仡欜?yàn)證狀態(tài)的計(jì)劃planforensuringmaintainingavalidatedstate.確保維持驗(yàn)證狀態(tài)的計(jì)劃VALIDATIONMASTERPLAN驗(yàn)證主

39、計(jì)劃AmanufacturershouldhaveaVMPwhichreflectsthekeyelementsofvalidation.Itshouldbeconciseandclearandcontainatleastthefollowing:生產(chǎn)商應(yīng)有一份VMP反映驗(yàn)證的關(guān)鍵要素。它應(yīng)該簡(jiǎn)潔清晰并至少包括：-titlepageandauthorization(approvalsignaturesanddates);書名頁和批準(zhǔn)(批準(zhǔn)簽名和日期)tableofcontents;目錄abbreviationsandglossary;縮寫和術(shù)語validationpolicy;驗(yàn)證方針phil

40、osophy,intentionandapproachtovalidation;驗(yàn)證的原理、目的和方法rolesandresponsibilitiesofrelevantpersonnel;相關(guān)人員的角色和責(zé)任resourcestoensurevalidationisdone;確保驗(yàn)證執(zhí)行的資源-outsourcedservices(selection,qualification,managementthroughlifecycle);外包服務(wù)(選擇、確認(rèn)和生命周期管理)-deviationmanagementinvalidation;驗(yàn)證偏差管理changecontrolinvalidati

41、on;驗(yàn)證變更控制-riskmanagementprinciplesinvalidation;驗(yàn)證風(fēng)險(xiǎn)管理規(guī)則training;培訓(xùn)scopeofvalidation;驗(yàn)證的范圍documentationrequiredinqualificationandvalidationsuchasprocedures,certificates,protocolsandreports;確認(rèn)和驗(yàn)證所需的文件，如規(guī)程、證書、方案和報(bào)告premisesqualification;設(shè)施確認(rèn)utilitiesqualification;公用設(shè)施確認(rèn)-equipmentqualification;設(shè)備確認(rèn)proces

42、svalidation;工藝驗(yàn)證cleaningvalidation;清潔驗(yàn)證-personnelqualificationsuchasanalystqualification;人員確認(rèn)例如分析人員確認(rèn)analyticalmethodvalidation;分析方法驗(yàn)證computerizedsystemvalidation;計(jì)算機(jī)化系統(tǒng)驗(yàn)證establishingacceptancecriteria;建立接受標(biāo)準(zhǔn)life-cyclemanagementincludingretirementpolicy;生命周期管理包括退役的方針requalificationandrevalidation;再確

43、認(rèn)和再驗(yàn)證relationshipwithotherqualitymanagementelements;與其他質(zhì)量管理要素的關(guān)系validationmatrix;驗(yàn)證矩陣references.參考文獻(xiàn)TheVMPshouldbereviewedatregularintervalsandkeptuptodateaccordingtocurrentGMP.VMP應(yīng)該每隔一段時(shí)間回顧并保持持續(xù)符合現(xiàn)行GMPQUALIFICATIONANDVALIDATIONPROTOCOLS確認(rèn)和驗(yàn)證方案Thereshouldbequalificationandvalidationprotocolsdescribi

44、ngthequalificationandvalidationtobeperformed.應(yīng)有確認(rèn)和驗(yàn)證方案描述所要執(zhí)行的確認(rèn)和驗(yàn)證。Asaminimumtheprotocolsshouldincludethefollowingsignificantbackgroundinformation:方案應(yīng)該至少包括下列重要的背景信息：theobjectives;目的thesite;場(chǎng)所theresponsiblepersonnel負(fù)責(zé)的人員-descriptionofthestandardoperatingprocedures（SOPs）tobefollowed;所遵循的標(biāo)準(zhǔn)操作規(guī)程描述equipm

45、entorinstrumentstobeused;所使用的設(shè)備或儀器standardsandcriteriaasappropriate;適當(dāng)?shù)臉?biāo)準(zhǔn)-thestageofvalidationorqualification;驗(yàn)證或確認(rèn)的階段theprocessesand/orparameters;工藝和/或參數(shù)-sampling,testingandmonitoringrequirements;取樣，測(cè)試和監(jiān)測(cè)需求-stresstestingwhereappropriate;壓力測(cè)試（如適用）calibrationrequirements;校準(zhǔn)需求-predeterminedacceptancec

46、riteriafordrawingconclusions;預(yù)定的用于下定結(jié)論的接受標(biāo)準(zhǔn)-reviewandinterpretationofresults;結(jié)果的審核和分析changecontrol,deviations;變更控制、偏差archivingandretention.歸檔和保留8.3Thereshouldbeadescriptionofthewayinwhichtheresultswillbeanalysed,includingstatisticalanalysiswhereappropriate.應(yīng)有一個(gè)結(jié)果分析方法，包括統(tǒng)計(jì)學(xué)分析（如使用）的描述Theprotocolshould

47、beapprovedpriortouse.Anychangestoaprotocolshouldbeapprovedpriortoimplementationofthechange.方案應(yīng)該在使用前被批準(zhǔn)。方案的任何變更應(yīng)在實(shí)施前被批準(zhǔn)。QUALIFICATIONANDVALIDATIONREPORTS確認(rèn)和驗(yàn)證報(bào)告Thereshouldbewrittenreportsonthequalificationandvalidationperformed.應(yīng)有所執(zhí)行的確認(rèn)和驗(yàn)證的書面報(bào)告Reportsshouldreflecttheprotocolsandproceduresfollowedandi

48、ncludeatleastthetitleandobjectiveofthestudy;makereferencetotheprotocol;referencetotheappropriateriskassessment;detailsofmaterials,equipment,programmesandcyclesused;proceduresandtestmethodswithappropriatetraceability.報(bào)告應(yīng)該反映所遵循的方案和規(guī)程并至少包括題目和目的；方案的參考；適當(dāng)?shù)娘L(fēng)險(xiǎn)評(píng)估的參考；所使用的材料、設(shè)備、計(jì)劃和周期的描述；適當(dāng)?shù)囊?guī)程和測(cè)試方法追溯Resultssho

49、uldberecordedandbeincompliancewithgooddataandrecordmanagementpractices.應(yīng)該記錄結(jié)果并符合良好數(shù)據(jù)和記錄管理規(guī)范。Resultsshouldbereviewed,analysedandcomparedagainstthejustifiedpredeterminedacceptancecriteria,interpretedandstatisticallyanalysedwhereappropriate.結(jié)果應(yīng)該被回顧、分析并與預(yù)定的接受標(biāo)準(zhǔn)比較，解釋和統(tǒng)計(jì)學(xué)分析（如適用）Resultsshouldmeettheaccepta

50、ncecriteria.Deviations,out-of-specificationandout-of-limitresultsshouldbedocumentedandinvestigatedaccordingtoappropriateprocedures.Ifthesedeviationsareaccepted,thisshouldbejustified.Wherenecessary,furtherstudiesshouldbeperformed.結(jié)果應(yīng)該符合接受標(biāo)準(zhǔn)。偏差、OOS和超限結(jié)果應(yīng)該按照適當(dāng)?shù)某绦蛴涗浐驼{(diào)查。如接受這些偏差，應(yīng)有正當(dāng)理由。必要時(shí)，應(yīng)進(jìn)行更進(jìn)一步的研究。Thec

51、onclusionofthereportshouldstatewhetherornottheoutcomeofthequalificationand/orvalidationwasconsideredsuccessful,andshouldmakerecommendationsforfuturemonitoringandsettingofalertandactionlimitswhereapplicable.報(bào)告的結(jié)論應(yīng)聲明確認(rèn)和/或驗(yàn)證的結(jié)果是否被認(rèn)為是成功的，并應(yīng)該對(duì)下一步的監(jiān)測(cè)和設(shè)置警戒限、行動(dòng)限（如適用）提供建議Thedepartmentsresponsibleforthequalif

52、icationandvalidationworkshouldapprovethecompletedreport.確認(rèn)和驗(yàn)證工作的責(zé)任部門應(yīng)該批準(zhǔn)完成報(bào)告Thequalityassurancedepartmentshouldapprovethereportafterthefinalreview.Thecriteriaforapprovalshouldbeinaccordancewiththecompanysqualityassurancesystem.質(zhì)量保證部門應(yīng)該在最終審核后批準(zhǔn)報(bào)告。批準(zhǔn)的標(biāo)準(zhǔn)應(yīng)該符合公司的質(zhì)量保證體系。Anydeviationsfoundduringthevalidati

53、onprocessshouldbemanagedanddocumented.Correctiveactionsshouldbeconsidered.在驗(yàn)證過程中發(fā)生的任何偏差應(yīng)該被管理和記錄，應(yīng)該考慮糾正措施。QUALIFICATION確認(rèn)Therearedifferentapproachesinqualificationandvalidation.Themanufacturershouldselectanappropriateapproachfortheconductthereof.確認(rèn)和驗(yàn)證有不同的方法，生產(chǎn)者應(yīng)該在其中選擇適用的方法。Figure1.TheV-modelasanexamp

54、leofanapproachtoqualificationandvalidation.圖一一個(gè)確認(rèn)和驗(yàn)證的V模型舉例*Note.Seetextbelowforclarificationontermsandstages備注：術(shù)語和階段描述見下列文本AllrelevantSOPsforoperation,maintenanceandcalibrationshouldbepreparedduringqualification.所有運(yùn)行、維護(hù)和校準(zhǔn)相關(guān)的SOP應(yīng)該在確認(rèn)期間被準(zhǔn)備妥當(dāng)Trainingshouldbeprovidedtooperatorsandtrainingrecordsshouldb

55、emaintained.培訓(xùn)應(yīng)該被提供給操作者并且應(yīng)有培訓(xùn)記錄Normally,qualificationshouldbecompletedbeforeprocessvalidationisperformed.通常地，確認(rèn)應(yīng)該在執(zhí)行工藝驗(yàn)證前完成Theprocessofqualificationshouldbealogical,systematicprocessandshouldfollowalogicalflowfromthepremises,followedbyutilities,equipment,toproceduresandprocesses.確認(rèn)的過程應(yīng)該符合邏輯、有條理和應(yīng)該遵循

56、從前提，然后公用設(shè)施、設(shè)備到程序和工藝的邏輯流程Stagesofqualificationshouldnormallystartwiththepreparationofuserrequirementspecifications(URS).Dependingonthefunctionandoperationoftheutility,equipmentorsystem,thisisfollowedby,asappropriate,differentstagesinqualificationsuchasafactoryacceptancetest(FAT),siteacceptancetest(SA

57、T),designqualification(DQ),installationqualification(IQ),operationalqualification(OQ)andperformancequalification(PQ).通常地，確認(rèn)的階段應(yīng)該從用戶需求規(guī)范(URS)的準(zhǔn)備開始。然后根據(jù)設(shè)施、設(shè)備或者系統(tǒng)的功能和操作特點(diǎn)，選擇不同的確認(rèn)階段，如工廠驗(yàn)收測(cè)試(FAT),現(xiàn)場(chǎng)驗(yàn)收測(cè)試(SAT),設(shè)計(jì)確認(rèn)(DQ)、安裝確認(rèn)(IQ)、運(yùn)行確認(rèn)(0Q)和性能確認(rèn)(PQ)。Onestageofqualificationshouldbesuccessfullycompletedbeforethe

58、nextstageisinitiated,e.g.fromIQtoOQ.確認(rèn)時(shí)，一個(gè)階段在開始下一個(gè)階段前被成功地完成，例如，從IQ到OQ。Insomecases,onlyIQandOQmayberequired,asthecorrectoperationoftheequipment,utilityorsystemcouldbeconsideredtobeasufficientindicatorofitsperformance.在某些情況下，只需要進(jìn)行IQ和0Q,設(shè)備、設(shè)施或系統(tǒng)的正確操作就可以被認(rèn)為它的性能的一個(gè)充分的指標(biāo)了。Majorequipmentandcriticalutilitie

59、sandsystems,however,mayrequireURS,DQ,IQ,OQandPQ.主要設(shè)備和關(guān)鍵設(shè)施和系統(tǒng)則可能需要URS、DQ、IQ、OQ和PQComputerizedsystems,includingequipmentwithsoftwarecomponent(s),requireuserandfunctionalrequirementsspecifications,designandconfigurationspecifications,developmentofSOPs,trainingprogrammesforsystemuseandadministration,and

60、anappropriatelevelofIQ,OQandPQverificationtesting.Thisincludestestssuchasstress,load,volumeandotherperformanceverificationteststhatmimictheliveproductionenvironment.ItalsoincludesuseracceptancetestingaccordingtodraftSOPsandtrainingaswellasend-to-endbusinessprocessesforintendeduse.計(jì)算機(jī)化系統(tǒng)，包括有軟件構(gòu)件的設(shè)備，需