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首页 OOS调差[1]

OOS调差[1].doc

OOS调差[1]

逄焕杰666 2011-07-20 评分 0 浏览量 0 0 0 0 暂无简介 简介 举报

简介:本文档为《OOS调差[1]doc》,可适用于自然科学领域,主题内容包含OOS调查起草修订人:Author日期:Date部门主管审查:DeptHeadApproval日期:DateQA批准:ApprovedbyQA日期:符等。

OOS调查起草修订人:Author日期:Date部门主管审查:DeptHeadApproval日期:DateQA批准:ApprovedbyQA日期:Date分发:Distribution:QA,QC目的:所得的检验结果可以是与趋势不符(OOT)或不符合规定(OOS)。这些异常结果应进行确认并且一旦被证实应进行调查以找出根本原因。本规程提供了如何处理这种检验结果的详细的操作指导。PURPOSE:Analyticalresultsobtainedcouldbeatypical(outoftrend,OOT)oroutofspecification(OOS)Theseaberrantresultsrequireverificationand,ifverified,investigationintotheirrootcauseThisprocedureprovidesdetailedinstructionsforconsistentandthoroughevaluationandinvestigationofsuchanalyticalresults范围:本规程包含了数据的处理、最终结果的调查和记录化验室负责与潜在的OOS或OOT结果有关的化验室所有调查的评价。SCOPE:Thisprocedurecovershandlingofdata,investigationanddocumentationoffinalresultsQClaboratoryhasresponsibilityfortheevaluationofallinvestigationsoflaboratorydataassociatedwithpotentialOOSorOOTresults本规程适用于所有按已批准的质量标准进行的检验。适用于但不仅限于下述物料:ThisprocedureappliestoalltestingagainstapprovedspecificationItapplies,butnotlimitedto,analyticalandphysicaltestingofthefollowingmaterials:进厂物料。Incomingrawmaterials中间体、中间控制样品及成品。Intermediates,Inprocesssamplesandfinalproducts稳定性试验样品。Stabilitysamples工艺验证和清洗验证的样品。Processandcleaningvalidationsamples本规程不适用于:Thisproceduredoesnotapplyto:在工艺研发(包括影响因素试验或加速试验)过程中所产生的潜在的OOSOOT因为在工艺研发过程中可能会出现预期的不符合规定限度的结果。PotentialOOSOOTresultsobtainedduringprocessdevelopment(includesstressoracceleratedstudy),wheresomeresultsareexpectedtofalloutsideofestablishedlimits方法验证和方法确认。Methodvalidationandverification方法转移。Methodtransfer范围:(续)SCOPE:(Cont)新化验员培训过程中所产生的结果。Analystqualification仪器确认校正。Equipmentqualificationcalibration参考文件:REFERENCEANDATTACHMENT:SOP题目SOPTITLE记录附件题目FORMSATTACHMENTSTITLE偏差调查附件:化验室偏差调查流程图DeviationInvestigationAttachment:LaboratoryInvestigationFlowChart附件:化验室初步调查检查帮助清单Attachment:AidtoAnalystSupervisorReviewinInitialLaboratoryInvestigationF化验室调查报告化验室初步调查LaboratoryInvestigationReportInitialInvestigationbyQCLaboratoryFLaboratoryInvestigationReportFurtherInvestigationbyQCLaboratoryF化验室调查报告发放记录LaboratoryInvestigationReportDistributionLogF化验室错误(KLE)记录KnownLaboratoryErrorLogF化验室OOS登记LaboratoryOOSLog定义:NADEFINITIONS:不符合规定的结果(OOS)任何不符合标准限度(定性或定量)规定的化验室检验结果(包括要求平行测定中的单个点的数据)。OutofSpecificationResult(OOS)Anylaboratorytestresult(includingindividualdatapointwhenreplicatearedetermined)thatfailsastatedspecificationlimit,eitherdescriptiveornumericallimit与趋势不符的结果(OOT)在标准规定限度之内的异常、非典型、或意料之外的检验结果。根据以往历史数据的检查和考虑该检验结果是不应该出现的。OutofTrend(OOT)Anunusual,atypicalorunexpectedtestresultwithinspecificationlimit,which,oninspectionandinconsiderationofprevioustestingresults,maynotbereasonablyexpectedtooccur注:在经调查以及被确认为OOT或OOS之前上述所描述的检验结果统称为“异常结果”。Note:AnalyticalresultsarisingfromdescriptionmentionedabovearealsoknownasaberrantresultsuntiltheseresultsareinvestigatedandclassifiedaseitherOOTorOOS定义:(续)DEFINITIONS:(Cont)质量标准为指定的检验、物料或产品所制订的可接受标准的数值或其范围。EstablishedSpecificationAvalueorrangeofvaluesthatdefinetheacceptancecriteriaforagiventest,materialorproduct可归结的原因对于导致产生异常结果的化验室错误或其他原因的一个详细的、科学合理的解释。AssignableCauseAdetailedandscientificallysoundexplanationoflaboratoryerrororothercausethatleadtooccurrenceofaberrantresult样品从指定物料中(通过已知方法)抽取一定数量的经明显标识送至化验室检验的代表性物料。SampleArepresentativequantityofmaterialtakenfromadefinedbulk(byaknownmethod),clearlyidentifiedandloggedintolaboratoryforanalysis初始样品溶液根据检验方法所配制的样品溶液包括初始的样品稀释液以及从初始样品配制而得的任何溶液。OriginalSamplePreparationAliquotofsamplepreparedaccordingtotestmethodforanalysis,whichincludesdilutionandanysolutionpreparedfromtheORIGINALsample初始数据根据规定的检验方法检验初始样品所得的检验数据。OriginalResultTestvalueobtainedonanalysisoforiginalsamplepreparationaccordingtospecifiedtestmethod无效数据基于科学合理的证据显示是在不正确的条件下或不适当的样品中产生的经调查后发现为不正确的结果。数据可以被考虑为无效的例子有:InvalidResultResultfoundtobeincorrectfollowingadocumentedinvestigationbasedonsoundscientificevidence,whichindicatesthattheresultproducedunderincorrectconditionorfromanimpropersampleExamplesofdataconsideredinvalidare:积分开始和结束的设定不正确。Incorrectstartandstopintegrationlocations未按检验方法规定的要求正确操作。Failuretoproperlyfollowinstructionsasrequiredintestmethodology溶液配制错误。Errorinpreparation仪器故障。例如:HPLC自动进样器进样失败。Instrumentmalfunction,egHPLCautosamplermissinjection在检验完成之前样品因放置时间过长而变质。Sampledeteriorationissuspectedduetolongqueuetimebeforetestingiscompleted根据方法学的要求样品超过了存放时间(包括配制的样品溶液以及未经处理的样品)。Sampleexceedsstoragetimeaspermethodology(Includessamplesolutionpreparationaswellasbulkrawmaterialsample)样品标准品的贮存不正确。Incorrectstorageofsamplestandard定义:(续)DEFINITIONS:(Cont)无效数据注:当数据或结果因为某一原因而舍弃且该原因影响到了在同一时间用同一方法检验所得的若干检验结果则受此影响的所有数据必须舍弃。无效数据应该划掉签名日期并予以说明。为报告需要无效数据不能被平均。InvalidResultNote:Whendataresultsareinvalidatedduetoafactorthataffectsanumberofanalyticalresultstestedatthesametimeusingthesamemethod,alldatathatareaffectedbythatfactormustbeinvalidatedInvaliddataresultsshouldbecrossedout调查对错误的潜在原因进行鉴别的一个系统化、文件化的过程以及随后所采取的适当工作(如科学合理的试验、从其他来源收集证据)以便于能鉴别出错误的可归结的或最有可能的原因。采取的任何科学合理的试验应作为调查的一部分在批准的方案中进行描述。InvestigationAsystematicdocumentedprocessbywhichthepotentialcausesforerrorareidentifiedandtheappropriatedfollowupworkthatmaybeundertaken(egscientificallysoundandjustifiableexperiments,gatheringofevidencefromothersources)toenabletheidentificationofassignableormostprobablecauseoferrorAnyscientificallysoundandjustifiableexperimentsundertaken,aspartofaninvestigation,mustbedescribedinanapprovedprotocol已知的化验室错误(KLE)在检验过程中由化验员、仪器、检验物料等所产生的能通过调查被证实的并可将数据判定为无效的错误。KnownLaboratoryError(KLE)Anerroroccurringinthetestingprocess,causedbyananalyst,apieceofequipment,thetestmaterials,etcthatcanbeproventhroughinvestigation,thatenablestheinvalidationoftheresulttobedeclared已知化验室错误的例子包括:ExamplesofKnownLaboratoryErrorincludes:计算错误Calculationerror称量错误(如重量、体积等)Measurementerror(weights,volumes,etc)使用了错误的、过期的、或其他有缺陷的标准Useofincorrect,expired,orotherwisedefectivestandards操作错误(如移液、转移等)Manipulationerror(pipetting,transferring,etc)未按书面的方法操作Failuretofollowtestmethodaswritten使用未经验证的或未经充分验证的方法使用未经批准的方法或修订方法Useofunapprovedmethodormodifiedmethod定义:(续)DEFINITIONS:(Cont)复试利用初始样品的等分部分或额外部分所进行的额外重复检验。注:复试有时是不可行的如:从动态过程(反应过程的中间体检验)中所得样品的检验此时测试的样品已被破坏或因为先前容器被敞开而使测试结果会被改变如对吸湿性物料的水份的测定。RetestAdditionalreplicateanalysisperformedusinganaliquotoradditionalportionofmaterialfromtheoriginalanalyticalsampleNote:Retestmaynotalwaysbepossible,egtestingasamplefroma‘dynamic’process(inprocesstestingofareactionmixture),wheretestingisdestructiveofthematerialtested,orwheretestingiscompromisedbypreviouslyopenedcontaineregdeterminationofmoistureofahygroscopicmaterial重新取样从原先已经检验的同一批物料中重新取样且不是从原先送至化验室的同一样品中抽取的。重新取样将根据详细规定的取样操作或批准的调查方案进行以提供一份新的样品供检验。只有在经调查表明最初检验的样品不具有代表性或因为已被用完或已受到损害时才能允许重新取样。注:留样并不被认为是重新取样。重新取样必须有书面的解释并经QA批准。ResampleAfurthersampletakenfromthesamebatchorlotofmaterialfromwhichtheoriginalsamplewastakenNotethatresampleisnottakenfromthesamesampleoriginallysubmittedtothelaboratoryResampleshouldbetakenincompliancewithaclearlydefinedsamplingprocedureoranapprovedinvestigationprotocol,toprovideanewsampleforanalysisResampleisonlyallowedwhenoriginalanalyticalsampleusedfortestingisshown,byinvestigation,tobe:NotrepresentativeofthebatchorlotOrbecauseithasbeenusedupOrcompromisedinsomemannerNote:AretainedsampleisnotconsideredaresampleTheremustalwaysbeadocumentedrationale,QAapproved,forresample控制样品原先已经鉴别和检验的物料且检验结果与该物料的历史数据相吻合。原先已经充分鉴别的产品也可用作控制样品。比较典型的是具有历史趋势数据的稳定样品是控制样品比较好的来源。ControlSampleAsampleofmaterialthathasbeenpreviouslycharacterizedandtestedandresultsobtainedbeenfoundtobeconsistentwithsimilarhistoricalresultsforthatmaterialAnyproductthathaspreviouslybeenwellcharacterizedmayalsobeusedtypically,astabilitysamplewithapriorhistoricaltrendisagoodsourceofcontrolsamples工艺错误在生产过程中产生的或与生产操作有关的错误且错误的根本原因可归结于生产操作并由此导致了OOSOOT结果的产生。ProcessErrorAnerroroccurredinorrelatedtothemanufacturingprocess,whererootcauseisknownordeterminedorattributedtotheprocess,whichmayresultinOOSOOTresults定义:(续)DEFINITIONS:(Cont)重新稀释对初始样品溶液和相应的标准溶液所进行的任何重新稀释或处理并重新检验以证实所得到的初始结果。重新稀释通常用于鉴别可能的样品配制问题且不能当作是复试。当对样品配制中间的某一步操作(如:稀释、移液等)有怀疑时重复该步操作是可以的。注:重新稀释操作取决于对样品的配制时间及其贮存条件中所掌握的该溶液样品的稳定性。RedilutionRepeatinganydilutionortreatmentoforiginalsampleanditsaccompanyingstandardsolutionforrepeatingtheanalysisortestmeasurementtoconfirmresultobtainedThisisusedtoidentifyapossiblesamplepreparationproblemandisnotconsideredaretestArealiquotisjustifiedwhenanintermediatestepinthesamplepreparationissuspect(egdilution,digestion,pipettingetc)Note:Redilutionisdependantuponsuitablesolutionsamplestabilityfromthetimeofpreparationanditsstorage重新进样重新读取对产生OOSOOT结果的初始样品溶液重新进样测定以证实实际得到的结果。注:如上所述当配制的溶液在给定的时间后会不稳定时重新进样重新读数有时也是不可行的。ReinjectionRereadReexaminationofthesamealiquotordilutionthatproducedOOSOOTresultinordertoconfirmtheactualresultobtainedNote:Asabove,thismaynotbepossiblewherethepreparedaliquotordilutionisknowntobeunstableafteragiventimeperiod有效检验结果在经批准的、科学合理的条件下取得的检验结果无论是否符合规定而且没有科学合理的理由以用来证明其是无效的或可疑的。ValidResultAresultfromtestingcarriedoutunderapproved,scientificallysuitableconditions,whetherwithinspecificationoroutside,andthereisnosoundscientificgroundsforinvalidatingthisresult规程:PROCEDURE:责任人操作RESPONSIBILITYACTION化验室初步调查INITIALINVESTIGATIONBYQCLABORATORY化验员一旦得到一个异常结果(注:任何的计算已经复核)化验员应立即通知其主管。AnalystImmediatelynotifySupervisorwhenanaberrantresultisobtainedNotethatnotificationshouldbedoneaftercalculationshavebeenchecked责任人操作RESPONSIBILITYACTION化验员QC主管如果得到异常结果的原因很简单、且完全可解释如计算错误、笔误、或抄写错误并且QC主管认同该解释则不需作进一步的调查。化验员在检验记录中写下错误原因及正确的数值QC主管签字确认。AnalystQCSupervisorWhenthereasonforaberrantresultiseasilyandcompletelyexplained,egcalculation,clerical,ortranscriptionerror,andtheSupervisorissatisfiedthatthereasonisvalidandnofurtherpracticalworkneedstobecarriedout,thentheanalystshouldenterthereasonfortheerrorandthecorrectvalue(s)inthenotebookSupervisorcountersignstheseentriesQC主管如果数据计算正确无误则需要正式的调查并且QC主管应将该初步调查记录在化验室调查报告(LIR)上。QCSupervisorWhencalculationofresultisfoundtobeaccurate,aformalinvestigationisrequiredandthisinitialinvestigationshouldberecordedintheLaboratoryInvestigationReport(LIR)FormInitialInvestigationbyQCSupervisor化验员首先化验员应从QC主管或其指定人员处取得一份化验室调查报告(LIR)初步调查表的复印件并得到一个LIR号。AnalystFirst,analystshouldobtainthenextsequentialLIRNumberfromtheLogbookandobtainanauthorizedcopyoftheLIRInitialInvestigationFormfromQCSupervisorordesignee初步调查是在化验室内部对样品检验过程中是否存在化验室已知错误而进行的有关调查。TheinitialLaboratoryInvestigationinvolvesinvestigating,withinthelaboratory,forknownerrorsduringtestingofthesample初步的化验室调查必须在异常结果报告的一个工作日内完成。ThisInitialLaboratoryInvestigationshouldbecompletedwithinoneworkdaywhenaberrantresultisreported采用年份的全部数字加上该年份中所发生化验室调查的相应连续数字给定唯一的LIR号。例如年发生的第一个化验室调查其LIR号为“”。AssignuniqueLIRNumberusingnumericfullyeardesignationfollowedbyasequentialnumbercorrespondingtotheoccurrenceinthatyearForexample,thefirstoccurrenceofwouldbeassignedanLIRNumberof“”化验员QC主管化验员和QC主管一起对所得的数据和结果进行初步的评价(包括对使用的移液管、容量瓶称量数值计算使用的仪器等进行目视检查)以确认是否存在任何可确认的化验室错误或笔误(已知的化验室错误)。在进行该阶段调查的同时完成LIR最初调查表。AnalystQCSupervisorWorkingtogetherwithSupervisor,analystshouldperformapreliminaryassessmentofthedataandresult(s)obtained(includingavisualcheckonpipettes,flasksused,weights,numberscalculations,equipmentused,etc)toestablishwhetherthereisanyidentifiablelaboratoryorclericalerror(KnownLaboratoryError,KLE)AnalystandSupervisorshouldcompletetheLIRInitialInvestigationFormastheyundertakethisphaseoftheinvestigation责任人操作RESPONSIBILITYACTION化验员QC主管注:a)化验员和QC主管可以利用附件给出的检查清单(化验员主管在化验室初步调查中的帮助清单)以帮助进行初步调查。AnalystQCSupervisorNotes:AnalystandSupervisorshallusechecklistgiveninAttachment(AidtoAnalystSupervisorReviewinInitialLaboratoryInvestigation)asanaidtoundertakethisinitialinvestigationb)当在调查与HPLCGC自动进样器有关的一个异常结果时且很明显是一个稳定性的系统并且平行进样中的一针明显是进样错误在这种情况下重新进样初始溶液以证实结果是允许的。但这需要有明确的记录并经主管签字(如同上面的描述)。WheninvestigatinganaberrantresultinvolvingaHPLCGCautosampleranditisclearlyobviousthatthereisa“stablesystem”andthatoneinjectionofreplicateinjectionisclearlymissinject,itispermissible,inthiscase,toreinjecttheoriginalsolutiontoconfirmresultsHowever,thisreinjectionneedstobeclearlydocumentedandsignedbytheSupervisorasinabove初步调查的评价REVIEWOFINITIALINVESTIGATION化验员和主管如果初步调查的结论是产生异常结果的原因是化验室错误则:AnalystSupervisorIftheconclusionoftheInitialInvestigationisthattheaberrantresultswasduetolaboratoryerror,then:不需要采取进一步的调查。Nofurtherinvestigationneedstobeperformed初始数据无效。Theoriginalresultsareinvalided根据可归结的原因必须重新稀释或全部重新检验。Theanalysismustberepeatedeitherbyredilutionorinitsentiretyaccordingtoassignedcause完成LIR初步调查表的初步调查评价部分并签名日期。CompletetheInitialInvestigationReviewsectionoftheLIRInitialInvestigationForm,signanddate报告新的检验结果。Newresultsshouldbereported在化验室错误记录上作好记录。RecordlaboratoryerrorintheKLElogbookLIR初步调查表应与数据记录页检验记录本一起保存或与产品检验有问题的稳定性试验档案一起保存。TheLIRInitialInvestigationFormshouldbefiledwitheachDataRecordingSheetlaboratorynotebook,orstabilityfilecoveringtheproductanalysisinquestion化验员和主管若经化验室初步调查最终未能证实有已知化验室错误(KLE)则结果可以是有效的并通知QA。AnalystSupervisorNotifyQAattheendoftheInitialLaboratoryInvestigationifnoKLEcouldbefound,andtheresultconsideredvalid责任人操作RESPONSIBILITYACTIONQA注:a)对于进厂物料的接收检验在化验室最初调查结束后若检验结果被证实并非由于KLE所致QC应通知QA。QA则将该批物料判定为不合格通知采购部门将物料退还给供应商。Note:Inthecaseofnewincomingrawmaterialanalysis,attheendoftheInitialLaboratoryInvestigationandifanalyticalresultisconfirmedasnotbeingduetoaKLE,QCshouldnotifyQAQAshouldthen“Reject”thebatchofrawmaterial,notifyPurchasingandarrangeformaterialtobereturnedtothesupplierb)对于在公司内贮存的复验物料QA可以决定采取进一步的调查。在这种情况下应按SOP执行。Inthecaseofretestedrawmaterialthathavebeenstoredatsite,QAmaydecidetoundertakefurtherinvestigationInsuchcase,SOPshouldbefollowed跨部门会议CROSSFUNCTIONALMEETINGQA一旦接到QC的通知QA应通知与此有关的生产、工程和物料等部门的人员并提醒注意产生问题的可能性。UponreceivingthenotificationfromQC,QAshouldnotifytherelevantProduction,EngineeringandMaterialtoalertpeopletopossibilityofaproductqualityproblem注:QA可决定召开一个跨部门的会议对异常结果进行讨论并要求生产、工程或物料部门在其部门内部进行调查以找出产生异常结果的可能原因。该会议必须在QA接收通知后的个工作日内进行以启动进一步的调查。Note:QAmaydecidetocallacrossfunctionalmeetingtodiscusstheaberrantresultandrequireProduction,EngineeringorMaterialManagementtoundertakeinvestigationsintheirrespectiveareastoidentifypotentialcausesofaberrantresultThismeetingtoinitiatefurtherinvestigationmustbeundertakenwithinworkdaysfromthedateeventreportedtoQAQCQA如果异常结果是由于可能的工艺错误导致的并且经生产部门证实则化验室不必再进行进一步的调查。则QC报告结果该批产品判为不合格。IfaberrantresultisduetoapotentialprocessingerrorandthisisconfirmedbyProduction,thennofurtherinvestigationneedstobecarriedoutbythelaboratoryThenQCreportstheresultsThebatchshallberejectedLIR初步调查表应与数据记录页检验记录本一起保存或与产品检验有问题的稳定性试验档案一起保存。TheLIRInitialInvestigationFormshouldbefiledwitheachDataRecordingSheetlaboratorynotebook,orstabilityfilecoveringtheproductanalysisinquestion责任人操作RESPONSIBILITYACTIONQC如果决定要求进行进一步的化验室调查则必须在LIR调查报告进一步调查中作好记录。IfitisdecidedthatfurtherQCworkisrequired,thismustbedocumentedinaLIRFurtherInvestigationQCQA如果决定不要求进行进一步的化验室调查则QC报告结果并启动偏差调查程序。IfitisdecidedthatnofurtherQCworkisrequired,thenQCreportstheresults,andDeviationInvestigationprocedureshallbeinitiatedQAQA应起草会议纪要或备忘录相关部门的调查报告将附在会议纪要或备忘录中。QAshouldwritemeetingminutesormemo,theinvestigationreportofrelevantdepartmentshallbeattachedtotheminutesormemo会议纪要或备忘录将附在LIR调查方案或偏差调查报告中(若适用)。TheminutesormemoshouldbeattachedtotheLIRInvestigationProtocolorDeviationInvestigationReport(ifapplicable)化验室进一步调查FURTHERQCINVESTIGATION化验员QC主管如果要求进行进一步的调查化验员从QC主管或其指定人员处获得一份LIR进一步调查的复印件。这些文件被看作是进一步调查所要求的最低水平的文件。Iffurtherworkisrequired,analystshouldobtainanauthorizedcopyoftheLIRFurtherInvestigationbyQCLaboratoryfromQCSupervisorordesigneeThesedocumentsaretoberegardsastheminimallevelofdocumentationrequiredforFurtherInvestigation根据需要可以起草更全面的方案报告作为这些表格的附页。AmorecomprehensiveprotocolreportmayneedtobedevelopedonadditionalpagestotheseFormsasrequired注:在QC开始实施任何额外的工作之前QA必须批准所有的方案。Note:QAmustapproveallprotocolsbeforeQCcarriesoutanyadditionalwork化验员QC主管利用进一步调查表格的形式QC主管和化验员必须详细说明产生问题的可能原因并通过可利用的数据设计一个旨在找出产生异常结果可归结的或最有可能原因的调查方案。UsingtheFurtherInvestigationform,QCSupervisorandanalystmustdefinepossiblecausesfortheproblemanddesignaninvestigationprotocolaimedatdeterminingtheassignableormostprobablecauseoftheaberrantresultviaavailabledata责任人操作RESPONSIBILITYACTIONQC利用方案用科学合理的的判断和说明对预先定义的复试次数进行说明在任何检验活动开始之前方案应被批准。Usingtheprotocol,apredefinednumberofretestsshouldbedocumentedusingscientificallysoundjudgmentandrationale,andshouldbeapprovedPRIORtoanytestingactivity注:如果所有不符合规定的结果是预期的则复试可能是不必要的(如:在产品有效期后或在加速试验后所得到的稳定性试验结果)。Note:Retestingmaynotbenecessaryifalloftheresultsoutsideofthespecificationareexpected(egastabilityintervalresultobtainedafterbatchexpirationoronacceleratedstability)化验员QC主管每个调查均需要逐个进行评价并在方案中科学合理地作好记录。采用“第二个化验员”的适用性应进行评价采用第二个化验员并不一定总是需要的。对于找出可归结的原因采用第二化验员仍是一个有效的工具并且可以增加复试数据的可信度。AnalystQCSupervisorEachinvestigationneedstobeevaluatedonacasebycasebasisanddocumentedintheprotocolusingscientificallysoundjustificationTheapplicabilityofa“SecondAnalyst”shouldbeevaluatedAsecondanalystisnotalwaysrequiredAsecondanalystcouldhoweverbeaneffectivetoolinfindinganassignablecauseandcouldimprovethepoweroftheretestdata使用“控制样品”有时可以找出可能的根本原因并且在使用时应事先详细说明控制样品的可接受标准。控制样品可以是稳定性样品或者是原先已经结构确证好的物料。Theuseofa“control”samplecouldassistinfindingthelikelyrootcauseandwhenused,acceptancecriteriaforthecontrolshouldbepredefinedAcontrolsamplecouldbeastabilitysampleorpreviouslywellcharacterizedmaterialQC主管QC主管应始终确保任何进一步的检验均是按照规定的和批准的调查方案进行的并对结果是否符合方案的可接受标准进行评价。如果结果符合方案的可接受标准则可以作出符合规定的结论并报告数据。QCSupervisorTheQCSupervisorshouldalwaysensurethatanyfurtheranalysesareundertakeninaccord

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