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1058ANALYTICALINSTRUMENTQUALIFICATION分析仪器的确认(USP39-NF34Page1055)INTRODUCTION介绍Alargevarietyoflaboratoryequipment,instruments,andcomputerizedanalyticalsystems,rangingfromsimplenitrogenevaporatorstocomplexmultiple-functiontechnologies(seeInstrumentCategories),areusedinthepharmaceuticalindustrytoacquiredatatohelpensurethatproductsaresuitablefortheirintendeduse.Ananalyst'sobjectiveistoconsistentlyobtainreliableandvaliddatasuitablefortheintendedpurpose.Dependingontheapplications,usersvalidatetheirprocedures,calibratetheirinstruments,andperformadditionalinstrumentchecks,suchassystemsuitabilitytestsandanalysisofin-processqualitycontrolchecksamplestohelpensurethattheacquireddataarereliable.Withtheincreasingsophisticationandautomationofanalyticalinstruments,anincreasingdemandhasbeenplacedonuserstoqualifytheirinstruments.各种各样的实验室设备、仪器、计算机化分析系统，从简单的氮吹仪到复杂的多功能技术（见InstrumentCategories），均被用于制药行业，以获得数据来确保产品达到预期用途。分析的目的是持续获得符合预期目的的可靠的有效数据。基于实际应用，使用者进行工艺验证、仪器校准，并进行额外的仪器检核，如系统适用性试验和中间质量控制分析检查样品，以确保所获得数据的可靠性。随着分析仪器的日益复杂化和自动化，对仪器确认的要求也在不断增加。Unlikemethodvalidationandsystemsuitabilityactivities,analyticalinstrumentqualification(AIQ)currentlyhasnospecificguidanceorprocedures.Competingopinionsexistregardinginstrumentqualificationandvalidationproceduresandtherolesandresponsibilitiesofthosewhoperformthem.Consequently,variousapproacheshavebeenusedforinstrumentqualification,approachesthatrequirevaryingamountsofresourcesandgeneratewidelydifferingamountsofdocumentation.ThischapterprovidesascientificapproachtoAIQandconsidersAIQasoneofthemajorcomponentsrequiredforgeneratingreliableandconsistentdata.Notethattheamountofrigorappliedtothequalificationprocesswilldependonthecomplexityandintendeduseoftheinstrumentation.ThisapproachemphasizesAIQ'splaceintheoverallprocessofobtainingreliabledatafromanalyticalinstruments.不同于方法学验证和系统适用性试验，分析仪器确认（AIQ）目前并没有明确的指导和规程。关于仪器确认和验证程序，以及执行它们的角色和职责，存在着互相矛盾的观点。由此导致，已有多种方法应用于仪器确认，而这些方法需要使用的资源数量各异并产生数量差异巨大的文件。本节为分析仪器确认（AIQ）提供了科学的方法，并将分析仪器确认（AIQ）作为产生可靠性和一致性数据的重要组成部分。注意，精确应用于确认工序的程度取决于仪器的复杂程度和预期用途。这种方法强调了AIQ从分析仪器中获得可靠数据的全过程中的地位。ValidationversusQualification验证vs确认Inthischapter,thetermvalidationisusedformanufacturingprocesses,analyticalprocedures,andsoftwareproceduresandthetermqualificationisusedforinstruments.Thus,thephrase“analyticalinstrumentqualification”(AIQ)isusedfortheprocessofensuringthataninstrumentissuitableforitsintendedapplication.在本节中，验证一词用于生产工艺、分析方法及软件程序中，而确认一词则用于仪器。因此，“分析仪器的确认”（AIQ）用于确保仪器适用于预期用途的过程。COMPONENTSOFDATAQUALITY数据质量的组成Therearefourcriticalcomponentsinvolvedinthegenerationofreliableandconsistentdata(qualitydata).Figure1showsthesecomponentsaslayeredactivitieswithinaqualitytriangle.Eachlayeraddstotheoverallquality.Analyticalinstrumentqualificationformsthebaseforgeneratingqualitydata.Theothercomponentsessentialforgeneratingqualitydataareanalyticalmethodvalidation,systemsuitabilitytests,andqualitycontrolchecksamples.Thesequalitycomponentsaredescribedbelow.组成可靠和一致数据（质量数据）的有四个关键部分。图1将这些部分展示在质量三角形的层级区域内。每层相加构成了整体质量。分析仪器的确认是产生质量数据的基础。构成质量数据的其他部分为分析方法验证、系统适用性试验和质量控制检验样品。这些质量部分详情如下。Figure1.Componentsofdataquality.图1.质量数据的组成AnalyticalInstrumentQualification分析仪器的确认AIQisthecollectionofdocumentedevidencethataninstrumentperformssuitablyforitsintendedpurpose.Useofaqualifiedinstrumentinanalysescontributestoconfidenceinthevalidityofgenerateddata.AIQ汇总了为确定仪器符合预期用途的文件证明。使用合格的分析仪器能提高生成数据的有效性。AnalyticalMethodValidation分析方法验证Analyticalmethodvalidationisthecollectionofdocumentedevidencethatananalyticalprocedureissuitableforitsintendeduse.Useofavalidatedprocedurewithqualifiedanalyticalinstrumentsprovidesconfidencethattheprocedurewillgeneratetestdataofacceptablequality.AdditionalguidanceonvalidationofcompendialproceduresmaybefoundinthegeneralinformationchapterValidationofCompendialProcedures1225.分析方法验证汇总了分析过程适用于预期用途的文件证明。使用经确认的分析仪器和验证过的方法所产生的测试数据才可能符合规定。关于药典中验证方法的额外指导可参见通则1225药典方法的验证。SystemSuitabilityTests系统适用性试验Systemsuitabilitytestsverifythatthesystemwillperforminaccordancewiththecriteriasetforthintheprocedure.Thesetestsareperformedalongwiththesampleanalysestoensurethatthesystem'sperformanceisacceptableatthetimeofthetest.USPgeneralchapterChromatography621presentsamoredetaileddiscussionofsystemsuitabilitytestsasrelatedtochromatographicsystems.系统适用性试验用于证实该系统符合方法中设定的标准。这些试验连同样品分析一起，确保系统的性能在测试时是适用的。USP通则621色谱法呈现了对色谱系统适用性试验更详细的讨论。QualityControlCheckSamples质量控制检查样品Manyanalystscarryouttheirtestsoninstrumentsstandardizedusingreferencematerialsand/orcalibrationstandards.Someanalysesalsorequiretheinclusionofqualitycontrolchecksamplestoprovideanin-processorongoingassuranceofthetest'ssuitableperformance.Inthismanner,AIQandanalyticalmethodvalidationcontributetothequalityofanalysisbeforeanalystsconductthetests.Systemsuitabilitytestsandqualitycontrolcheckshelpensurethequalityofanalyticalresultsimmediatelybeforeorduringsampleanalysis.许多分析员用经标准物质和/或校准标准品校准后的仪器进行测试。有些分析员还要求添加质量控制检查样品来保证试验过程中或持续的试验适用性。通过这种方式，AIQ和分析方法验证在测试前提高了分析的质量。系统适用性试验和质量控制检查则在样品分析前或过程中确保了分析结果的质量ANALYTICALINSTRUMENTQUALIFICATIONPROCESS分析仪器确认程序Thefollowingsec