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1058ANALYTICALINSTRUMENTQUALIFICATION分析仪器的确认INTRODUCTION介绍Alargevarietyoflaboratoryequipment,instruments,andcomputerizedanalyticalsystems,rangingfromsimplenitrogenevaporatorstocomplexmultiple-functiontechnologies(seeInstrumentCategories),areusedinthepharmaceuticalindustrytoacquiredatatohelpensurethatproductsaresuitablefortheirintendeduse.Ananalyst’sobjectiveistoconsistentlyobtainreliableandvaliddatasuitablefortheintendedpurpose.Dependingontheapplications,usersvalidatetheirprocedures,calibratetheirinstruments,andperformadditionalinstrumentchecks,suchassystemsuitabilitytestsandanalysisofin-processqualitycontrolchecksamplestohelpensurethattheacquireddataarereliable.Withtheincreasingsophisticationandautomationofanalyticalinstruments,anincreasingdemandhasbeenplacedonuserstoqualifytheirinstruments.极其多种多样的实验室设备、仪器、计算机分析系统，从简单的氮吹仪到复杂的多功能技术（见仪器种类），被应用于制药工业，以取得数据来确保产品适合其预定用途。分析员的目标是持续地获得适合其意图的可靠和有效的数据。取决于具体的应用，使用者验证其方法、校准其仪器，并进行额外的仪器检查，例如系统适用性测试和中间质量控制检查样品的分析，以便帮助确保所获得的数据是可靠的。随着分析仪器的复杂性和自动化程度不断增加，使用者已经感受到了不断增加的确认其仪器的要求。Unlikemethodvalidationandsystemsuitabilityactivities,analyticalinstrumentqualification(AIQ)currentlyhasnospecificguidanceorprocedures.Competingopinionsexistregardinginstrumentqualificationandvalidationproceduresandtherolesandresponsibilitiesofthosewhoperformthem.Consequently,variousapproacheshavebeenusedforinstrumentqualification,approachesthatrequirevaryingamountsofresourcesandgeneratewidelydifferingamountofdocumentation.ThischapterprovidesascientificapproachtoAIQandconsidersAIQasoneofthemajorcomponentsrequiredforgeneratingreliableandconsistentdata.Notethattheamountofrigorappliedtothequalificationprocesswilldependonthecomplexityandintendeduseoftheinstrumentation.ThisapproachemphasizesAIQ’splaceintheoverallprocessofobtainingthereliabledatafromanalyticalinstruments.不同于验证和系统适用性工作，分析仪器的确认（AIQ）目前尚没有具体的指导方针或程序。关于仪器确认和验证程序，以及这些程序的执行者的角色和职责，存在着相互冲突的多种观点。由此导致，多种方法已经应用于仪器确认，而这些方法要求使用的资源数量各异并产生数量差距很大的文档。此通则为AIQ提供了科学的方法，并将AIQ视为产生可靠和一致的数据所必需的主要组成部分之一。注意，应用到确认过程的严格程度将由该仪器的复杂性和预定用途来决定。这个方法强调了AIQ在从分析仪器中获得可靠数据的全过程中的位置。ValidationversusQualification验证对确认Inthischapter,thetermvalidationisusedformanufacturingprocesses,analyticalprocedures,andsoftwareproceduresandthetermqualificationisusedforinstruments.Thus,thephrase“analyticalinstrumentqualification”(AIQ)isusedfortheprocessofensuringthataninstrumentissuitableforitsintendedapplication.在此通则中，验证一词用于生产工艺、分析方法、软件程序，而确认一词用于仪器。因此，“分析仪器的确认”（AIQ）一词用于确保仪器适用于其预定用途的过程。COMPONENTSOFDATAQUALITY数据质量的组成部分Therearefourcriticalcomponentsinvolvedinthegenerationofreliableandconsistentdata(qualitydata).Figure1showsthesecomponentsaslayeredactivitieswithinaqualitytriangle.Eachlayeraddstotheoverallquality.Analyticalinstrumentqualificationformsthebaseforgeneratingqualitydata.Theothercomponentsessentialforgeneratingqualitydataareanalyticalmethodvalidation,systemsuitabilitytests,andqualitycontrolcheckssamples.Thesequalitycomponentsaredescribedasbelow.在产生可靠和一致的数据（质量数据）的过程中涉及了四个重要的组成部分。图1以层叠形式在质量三角形内展示了这些组成部分。每层相加构成了总体质量。分析仪器确认构成了产生质量数据的基础。作为质量数据产生的基础的其他组成部分为分析方法验证、系统适用性测试、质量控制检验样品。这些质量部分描述如下。AnalyticalInstrumentQualification分析仪器确认AIQisthecollectionofdocumentedevidencethataninstrumentperformssuitablyforitsintendedpurpose.Useofaqualifiedinstrumentinanalysescontributestoconfidenceinthevalidityofgenerateddata.AIQ是证明某个仪器表现得适合其预定用途的文件证据的汇总。在分析中使用确认过的仪器确保了对所生成数据的有效性的信心。AnalyticalMethodValidation分析方法验证Analyticalmethodvalidationisthecollectionofdocumentedevidencethatananalyticalprocedureissuitableforitsintendeduse.Useofavalidatedprocedurewithqualifiedanalyticalinstrumentsprovidesconfidencethattheprocedurewillgeneratetestdataofacceptablequality.AdditionalguidanceonvalidationofcompendialproceduresmaybefoundinthegeneralinformationchapterValidationofCompendialProcedures1225.分析方法验证是某个分析方法适合其预定用途的文件证据的汇总。使用确认过的分析仪器和验证过的方法确保了该方法将会产生质量可接受的测试数据的信心。关于药典方法的验证方法的额外指导原则可以在通则药典方法的验证1225中找到。SystemSuitabilityTests系统适用性测试SystemsuitabilitytestsverifythatthesystemwillperforminaccordancewiththeQualityControlCheckSamplesSystemSuitabilityTestsAnalyticalMethodValidationAnalyticalInstrumentQualificationFigure1.Componentsofdataqualitycriteriasetforthintheprocedure.Thesetestsareperformedalongwiththesampleanalysestoensurethatthesystem’sperformanceisacceptableatthetimeofthetest.USPgeneralchapterChromatography621presentsamoredetaileddiscussionofsystemsuitabilitytestsasrelatedtochromatographicsystems.系统适用性测试证实该系统的表现将会符合此方法中设定的标准。这些测试与样品分析仪器进行，从而确保此系统的表现在测试的时候是可以接受的。USP通则色谱法621呈现了对于色谱系统的系统适用性测试的更加具体讨论。QualityControlCheckSamples质量控制检验样品Manyanalystscarryouttheirtestsoninstrumentsstandardizedusingreferencematerialsand/orcalibrationstandards.Someanalystsalsorequiretheinclusionofqualitycontrolchecksamplestoprovideanin-processorongoingassuranceofthetest’ssuitableperformance.Inthismanner,AIQandanalyticalmethodvalidationcontributetothequalityofanalysisbeforeanalystsconductthetests.Systemsuitabilitytestsandqualitycontrolcheckshelpensurethequalityofanalyticalresultsimmediatelybeforeorduringsampleanalysis.许多分析员在以标准物质和/或校准标准品进行标准化的仪器上进行他们的测试。