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sop10.pdf

sop10

逄焕杰666
2011-07-20 0人阅读 0 0 0 暂无简介 举报

简介:本文档为《sop10pdf》,可适用于自然科学领域

EditionNumber:EffectiveDate:APPROVEDEdStatus:CurrentMMDDYDepartmentRDRAQCQASOP#ASTANDARDOPERATINGPROCEDURESPage:ofPROCEDURESFORHANDLINGOOSRESULTSPURPOSEThepurposeofthisStandardOperationProcedureistoestablishaprocedurefortheroutinehandlingofoutofspecification(OOS)laboratoryresultsTheinvestigationor‘failureinvestigation’shouldwhereeverpossibleidentifythecauseoftheOOSandevaluateitsimpactRESPONSIBILITYEachAnalystorResearcherisresponsiblefortheimmediateanalyticalreviewofOOSresultsincooperationwiththelaboratoryheadofsupervisordelegateAllsolutionsandstandardsmustbepreservedandproperlystoredThelaboratoryheadofsupervisorisresponsibleforthefinaldecisionastothedispositionanduseoftheresultFREQUENCYImmediatelyafterwards(wherepossible)orwithintodaysofeachcompletedanalyticaltest(afterbeingchecked,auditedandreviewedbythesupervisor)PROCEDUREaAnalystsmayclassifyOutofSpecificationTestResults(OOS)asreversibleorasnonreversibleduetoeithera:ÜgenuinelaboratoryerrororÜsamplingerrorNonreversibleclassificationmaycover:Ümanufacturingorprocessingerrors(includingmanufacturingoperatorerror)bInvestigationforGenuineLaboratoryAnalyticalErrorAnalystsmustinvestigateforlaboratoryerrorswhichcanoccurwhenanalystsmakeanalyticalmistakesCheckifsampleswereincorrectlyprepared,diluted,injectedorstoredatinappropriateenvironmentaltemperaturesorthatcontainersnotproperlyclosedorpossiblynotsampledinthecorrectdesignatedsamplingcontainereSuspectedlaboratoryerrormustbeinvestigatedandifagenuineerrorisfound,thentheOOSresultmustimmediatelybeinvalidatedTheOOSresultmustbedisregarded(afterappropriaterecordingandfiling)cEachAnalystshallreviewforcompletenesstheentiretestprocedure,equipmentcalibrationandcalculationusedinobtainingthetestresultusingtheattachedguidelinechecklistsEditionNumber:EffectiveDate:APPROVEDEdStatus:CurrentMMDDYDepartmentRDRAQCQAPROCEDURESFORHANDLINGOOSRESULTSPage:ofdThesupervisorshallreviewanddiscussindepthwiththeanalyst,theexecutionoftheentireanalyticaltestingprocedure,equipmentandcalculationusedeOncethenatureoftheOOShasbeenidentifiedasanlaboratoryerrorarepeattestmustbeperformedandtheinitialtesttotallydiscardedasareversiblelaboratoryerror(sincetheinitialtestresultwasproveninvalid)fTheanalyticaloranalysterrormustbethoroughlydocumentedandproperlyinvalidatedwithwrittenreasons,togetherwiththesupervisorandanalystsignaturesanddateoftheinvalidationprocessINCONCLUSIVEERRORSRETESTgAninconclusiveerrorisanOOSwherethe'supervisoranalystinvestigation'didnotdrawafirmconclusionandthereasonfortheerrorwasnotclearlyidentifiedhRetestwithnewaliquot(replicates,ifrequired)fromthesamesample,ifthesamplingprocedurewasprovenOKbyinvestigationiIfthesamplingprocedureisfoundtobeinerror,thenresamplethetargetmaterialisundertakenandanewduplicateanalysisisperformedDECISIONTREELIMITATIONjAnoverviewofOutofSpecificationResultsproceduresisprovidedbyadecisiontreeflowchartThedecisiontreeprovidesalogicalsetofproceduralstepsinordertostandardizetheinvestigativeprocedureforallanalystswhenperforminganOOSinvestigationfResamplingthematerialforanewrepresentativesampleshouldtakeplaceonlywhentheoriginalprocedurewasfoundtobeclearlynonrepresentativeofthewholeDOCUMENTATIONkOutofspecification(OOS)TestResultsReportor‘failureinvestigationTestResultReport’ispreparedandfiledEndofDocument‚ƒ„…†‡ŒŽEditionNumber:EffectiveDate:APPROVEDEdStatus:CurrentMMDDYDepartmentRDRAQCQAØCHECKLIST×SOP#AOUTofSPECIFICATIONRESULTS‘…AveragingpassingandOOSTestResultstogetherisnotpermittedasitconcealsthefullanalyticalpicture…’IDENTIFYINGOOSTESTRESULTSDoesthefirmshaveaclearSOPspellingouttheprocedureandinvestigationsrequiredwheneveranOOSresultisobtainedqYesqNoAreallfirm's'rejectedbatch'OOSresultsinvestigatedaswellqYesqNoAretheprevious(orrelated)batchesassociatedwiththefailedbatchspecificationreviewedandtheoverallimpact(onquality)evaluatedqYesqNoArewritteninvestigationsundertakenandthenfollowupproceduresrecommendedinwritingqYesqNoAretheinvestigationsperformedinatimelymannerandfollowadefensiblescientificlogic(seeattachedDecisionTree)qYesqNoDoesthecompanies'InvestigationSOP'includethethreekeytenantsieTOINVESTIGATETOCONCLUDETOFOLLOWUPqYesqNoHavethelaboratoryanalystsbeeninstructedtokeeptheoriginal'suspecttestsolutions'forpossiblereanalysis(RefDecisionTree)qYesqNoWhenanOOShasbeendetecteddoestheinitialreview,beforetheinvestigation,checkforinstrumentorsystemsuitabilitymalfunction,faultyreagents,calculation,documentationortranscribingerrorsqYesqNoIfnoclearanalyticalerrorsaredetectedina'suspectresult'doesacomprehensive'failureinvestigation'ALWAYSfollowqYesqNoWheremalfunctionsareidentifiedanddetectedareallprior'suspectdata'evaluatedandreviewedforapossiblerelated(orsimilar)errorsqYesqNoAreanalyticalfailurestrackedbacktotheiroriginalpointoffailureqYesqNoWhenafaultylabprocedureisdetected,istheanalyticaltestprocedureimmediatelyterminated(asamatterofroutine)qYesqNoHavetheanalystsbeentrainedtoimmediatelyreporttotheirsupervisorsanobviouserrororananalyticalfaultqYesqNoAreobviouserrors(spilling,incorrectdilution,injectionvolumeetc)documentedinthelabbookandabrandnewtestrestartedqYesqNoPage:ofEditionNumber:EffectiveDate:APPROVEDEdStatus:CurrentMMDDYDepartmentRDRAQCQAØCHECKLIST×SOP#AOUTofSPECIFICATIONRESULTS‘…failureinvestigationsareconductedtodeterminewhatcausedtheunexpectedOOSresult…’INVESTIGATINGOOSTESTRESULTSDoesthesupervisor's'initialassessment'followawritteninhouse'SOPprocedure'qYesqNoAretheretained'suspect'samplepreparationsexaminedduringthe'initialassessment'andthenretestedpromptlyoninitiatingthe'failureinvestigation'qYesqNoWhereaclearerrorisidentified,istheresultimmediatelyinvalidatedqYesqNoWhereclearerrorisNOTidentified,isafailureinvestigationconductedimmediatelyqYesqNoIsthefirm'sfullscalefailureinvestigationfullypredefinedinwritingqYesqNoDoesthefirm'sownQCUnitperformthe'fullscalefailureinvestigation'qYesqNoDoesthegeneralreviewincludealistofrelatedbatcheswhichmaybeimpactedqYesqNoDoesthefullscalefailureinvestigationincludetheproductionsideandthelaboratorysideqYesqNoDoesthelaboratoryprotocolincludethetwokeystepsretestingtheoriginalsampleandtestinganewsamplefromthebatchlotqYesqNoRetestingtheoriginalsamplewithanewanalyst,isgenerallythefirststepafterthe'initialassessment'iscompletedqYesqNoArethenumberofretests(usuallyduplicates)specifiedandnotexceededAveraging'originalsuspect'andretestresultsisforbiddenqYesqNoWhenimproperlypreparedsamplesareprovenasfaulty,thentheoriginaltestresultsmaybeimmediatelyinvalidatedqYesqNoThefirmmayresamplewhentheinvestigationhighlightsthattheoriginalsamplewasunrepresentativeqYesqNoWheretheinvestigationconcludesthatthesamplingmethodisinerroranewsamplingmethodmustbedevelopedandqualifiedqYesqNoToprovetheoriginalaliquotisfaulty,theanalystpreparestwoadditionalaliquotsandcomparesthethreesetsofresultsqYesqNoPage:ofEditionNumber:EffectiveDate:APPROVEDEdStatus:CurrentMMDDYDepartmentRDRAQCQAØCHECKLIST×SOP#AOUTofSPECIFICATIONRESULTS‘…Batchesmustbeformulatedwiththeintenttoprovideofthelabeledamount…'AVERAGINGINOOSRESULTSAveragingresultsfromastandardsolutionoratestaliquotisacceptable(ieaveragingreplicateresults)qYesqNoAveragingresultsfrommicrobialcountplatesarequiteacceptableqYesqNoAveragingasetofresults,wheresomeareOOSisnotacceptableqYesqNoHidinganOOSresultinanyaverageisnotacceptableqYesqNoWhentheintentistohighlightvariabilitywithintheproductthenaveragingisnotacceptable,butRSD(CV)valuesaregenerallyreportedtoshowstatisticalsignificanceqYesqNoReplicatepeakresponseswhethertestorstandardshouldbeaveragesasoneresultqYesqNoAreanalyststrained,sonottoaveragepassingandOOSresultstogetherinordertohidethefailingresultsqYesqNoCompositeassays,requireonlyoneassayresultandareinfactaverageassayvalues,asopposedtoindividualcontentuniformityvaluesqYesqNoOUTLIERUSEINOOSRESULTSWhere'control'and'specification'lowerandupperlimitsareusedinQCcriteriaanOUTLIERmaybeoutsidethecontrollimitsbutinsidethespecificationslimitsieanexampleofOUTLIERuseqYesqNoAnalystaretrainednottoassumeOUTLIERSastestingerrorsbutinherentvariabilityinthesampleqYesqNoThefirmhasanOUTLIERSSOPdetailingtheuseofOUTLIERTESTSqYesqNoOUTLIERSarenotpermissibleinContentUniformityandDissolutiontestsqYesqNoWheretheintentistomeasurethevariability,OUTLIERSshouldnotbeusedqYesqNoPage:ofEditionNumber:EffectiveDate:APPROVEDEdStatus:CurrentMMDDYDepartmentRDRAQCQAYESNOYESNOYESIFYESBThenDon'tApplyOutliersTo:ContentUniformityDissolutiontestCompositeAssaysOutofSpecificationDecisionTreeOOSDETECTED(FollowRoute'A'(lab)andRoute'B'(mfg))InvestigatePRODUCTIONLABORATORYInvalidateresultretest(DONOTRETAINRESULT)NOARetestSameSampleDifferentAnalystOOSNOSuspectresultOOSSPECIFICATIONFAILURE(EvaluateBatchforRejection)ProductPASSESRESAMPLENewrepresentativespecimenOOSRetainReportresultIFYESClearlaboratoryerrorDECISIONTREE(IJGDVol#)

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