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SOP for OOS and OOT.doc

SOP for OOS and OOT

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《SOP for OOS and OOTdoc》,可适用于自然科学领域

DenneSOPer​ PurposeTodescribetheproceduresandresponsibilitiesforhandlingofresults,generatedinMicrobiologicalLaboratory,whichareeitherOOS(OutofSpecification)orOOT(OutofTrend)​ Scope​ GeneralOOSOOTresultsobtainedfromanalysisofAPI’s,finishedproductsandrawmaterialincludingwaterusedintheproductionbutwiththefollowingexceptions​ Exceptionsandspecialcases​ NonconfirmingpositiveandnegativecontrolsAnalyseswhereresultsfrompositiveandornegativecontrolsarenotaffirmativecanberepeatedwithoutfurtherinvestigationThelaboratorydocumentationforthefailedtestmustincludeanoteasexplanationNofurtherreporting​ DiscontinuationofanalysisAnalysescanbediscontinuedduetoerrorsintestingprocedureorproblemswithequipmentuntilthetimeofincubationThelaboratorydocumentationforthefailedtestmustincludeanoteasexplanationNofurtherreporting​ StabilitysamplesThefirsttimeasampleresultexceedsalimititisinvestigatedaccordingtothisSOPTheretestresultcanprovideinformationonwhethertheoriginalresultisnotrepresentativeofthebatchofsamplestakenoutforstabilityProvidedthattheresultisnotinvalidated,confirmativeOOSOOTresultslaterinthestabilityperiodwillonlybereportedinthedeviationhandlingsystem​ IntermediatesfromproductionIngeneralOOSOOTresultsarenotinvestigatedaccordingtothisprocedureunlessotherwisespecifiedinotherrelevantdocumentIfsospecified,thefirsttime(definedasexceedingoflimitafternormaltestresultsforthesamplepoint)asampleresultexceedsalimititisinvestigatedaccordingtothisSOPTheinvestigationislikelytoincluderesultsfromsuccessivesamplesfromsameproducttypeWhentheOOSOOTinvestigationiscompleteandprovidedthattheresultisnotinvalidated,confirmativeOOSOOTresultsobtainedonsubsequentsamplesfromsameproducttypewillonlybereportedinthedeviationsystem​ EnvironmentalmonitoringsamplesAredealtwithatperiodicmeetingsbetweenQRTandtheresponsiblemanager(productionorlaboratory)andOOSOOTresultsarereportedbyQRT​ PositivesterilitytestOOSwillberegisteredaccordingtothisprocedurebutinvestigatedandreportedinaccordancewithSOPforinvestigationofpositivesterilitytest​ Water,usedinproductionThefirsttime(definedasexceedingoflimitafternormaltestresultsforthesamplepoint)asampleresultexceedsalimititisinvestigatedaccordingtothisSOPQRTdecidesifadditionalsamplingisrequiredTheinvestigationislikelytoincluderesultsfromsuccessivesamplesfromsamesamplingpointWhentheOOSOOTinvestigationiscompleteandprovidedthattheresultisnotinvalidated,confirmativeOOSOOTresultsobtainedonsubsequentsamplesfromsamepositionwillonlybereportedinthedeviationsystem​ DissolutiontestResultsarenotconsideredOOSOOTuntiltheinterpretationcriteriaincurrentUSP<>areexceeded​ Responsibilities​ Laboratorytechnicians​ IdentifyOOSOOTresultsandreport,withinthefollowingworkingday,tothelaboratorymanagerorsubstitute​ Ifpossiblethelaboratorytechniciansmustassurethattestrelevantmaterial(fexsamplesolutions)isnotdiscardedbeforetheinvestigationiscompleted​ EquipmentsuspectedtobethecauseofanOOSOOTshouldbequarantinedduringtheperiodoftheinvestigation​ FillingoutthepartoftheOOSOOTreportrelatedtothelaboratoryinvestigation​ Laboratorymanagerorsubstitute​ NotifyReleaseTeamimmediately​ Initiateandassureacompleteinvestigationofactivitiesinthelaboratory​ Initiateretestingorreanalysis​ Initiateandcomplete(inclsigningoff)laboratoryinvestigationreport​ Intheeventofalaboratoryinvestigationwherenolaboratoryerrorisfound,contactQRTtoassurethatrelevantinformationispassedontotheproductioninordertoinvestigateapossibleprocessrelatederror​ SendthesignedreporttoQAforapproval​ Definitions​ ResultIsthefinalqualitativeorquantitativevalue,determinedby,anapprovedtestmethodIfthetestmethodrequiresmultipledeterminations(LALtest,TotalViableCount,microbiologicalpotency,ID),itisonlythefinalresult,whichisevaluatedinaccordancewiththespecificationIncaseswheremultipledeterminationsshowlargervariationsdeviationsthanthelimitdefinedforthemethod,thedescriptioninchapterisfollowedforthemethodinquestion​ Outofspecification(OOS)resultIsatestresultwhichdoesnotcomplywiththerequirement,describedinthespecification,fortheproductEx:WhenthespecificationforTotalViablecountis<cfug,aresultoforhigherisOOS​ Outoftrend(OOT)resultIsanunusualabnormalresultwhichisnotanOOSresultEx:GiventhatpotencyforapolymyxinBsulphateproductionampleusuallyisµgmgapotencyresultofeitherorµgmgwouldbeanOOTresult​ ReanalysisIsperformanceofanextra,normaltestonthesamesamplepreparationAreanalysiscannotinvalidateanOOSOOTresult,unlessitistheresultofaprovenlaboratoryerrorReanalysisinthemicrobiologicallaboratoryisusuallynotanoptionduetothenatureofthetestsSamplepreparationsareusuallydiscardedimmediatelyafterthetesthasbeenperformedasthemicrobiologicalqualityofitwillchangeovertime​ RetestsAretests,whichareperformedifalaboratoryerrorcannotbeimmediatelydocumentedPerformedontheoriginalsamplewithnewweighingspreparationstoconfirmordisconfirmanOOSorOOTresultAretestcannotinvalidateanOOSresultunlessitisaresultofaprovenlaboratoryerror​ ResamplingIsthecollectingofanewsamplefromtherawmaterial,theintermediateorthefinishedproductResamplingistobeperformedonlyifthereisaninsufficientsampleamountoftheoriginalsampletocompleteretestingorifaninvestigationindicatesthattheoriginalsamplecannotbeconsideredrepresentativeofthebatchItisalsotobeconsidered,whetherothertestsperformedontheoriginalsamplemustberepeated​ LaboratoryerrorErrorduetosamplestorageinthelaboratory,testpreparation,analysisandincubationandalsoincludeinstrumentalerror​ ProcessrelatederrorErroroccurringintheproductionprocess​ LaboratoryinvestigationAdocumentedinvestigationinthelaboratorywherethepurposeistodeterminethereasonforanOOSorOOTresultDocumentedinencl​ OSOOTreport(encl)IsusedtoreportOOSOOTresults,reanalysisandretestresults,documentinvestigations,determineinvestigatethereasonforOOSOOTresults,authorizeretestsandinterpretandconcludeontheobtainedresultsCorrectiveactions,ifanyshouldbementioned​ Laboratoryinvestigation(encl)​ InvestigationcauseAnOOSOOTresultwithoutprovenlaboratoryerror​ TimeframeInvestigationandreportingisperformedwithoutdelayandshouldbecompletedwithinworkingdays​ NumberofretestsRefertothespecifictestinchapterIftheserulesarenotfolloweditshouldbeexplainedinthereport​ OOSOOTreport,enclAllboxesshouldbefilledinwiththerequestedinformationTheinvestigationasaminimumaddressesthefollowing:​ ExaminationoftheperformedprocedureForexdescribeanydeviationsfromtheprocedureandtheconsequenceshereof​ ExaminationofequipmentForexdescribeiftheequipmentissuspectedtobethecauseandanyprecautionsthatshouldberespected(forexquarantineduringinvestigation)Forexreferencerelevantcalibrationdata​ ExaminationofmediaandreagentsForexdescribeanyproblemswithpositivegrowthcontrolsForexreferenceautoclavingconditionsfortheusedmedia​ ExaminationofcalculatedvaluesandrawdataIfrelevant​ ConclusiononthelaboratoryinvestigationMustdescribeiftheOOSOOTresultiscausedbyaprovenlaboratoryerrorornotandifsowhatthecauseis​ ConclusionontheretestingRefertothespecifictestinchapterRetestresultsmustbereferencedDataNumberofretestsDataprocessingOOTCarriedoutbyanotherlaboratorytechnician(ifpossible)TheaverageoforiginalresultandretestresultsisusedOOSCarriedoutbyanotherlaboratorytechnician(ifpossible)Theaverageoforiginalresultandretestresultsisused​ Ifthereforsomemethodsisareasonforperformingmoreorlessreteststhanlistedabove,thisshouldbejustifiedbeforeinitialisingtheretests​ Thefinalresultisdeterminedastheaverageofalltestresultsobtained,eventhoughoneormoreoftheresultsareOOSIftheaverageoftheoriginalOOSresultandtheretestresultsarewithinthespecification,thefinalresultisstillOOSReleaseTeamevaluateshowtheresultistobeusedinconnectionwithrelease​ DocumentationOOSOOTreportsaregeneratedbytheChemicallaboratoryandASIlabAcontinuosnumberisgivenbytheleaderoflaboratory,whoalsologstheinformationelectronicallyforannualreviewoftrendsNumberingisindicatedas:YeardeptnoAPIorFPX,whereXiscontinuosAfterapprovalbytheleaderofthelaboratoryandauthorisationbyQA,thereportwiththeanalysisresultsissenttoReleaseTeamwhoarchivesittogetherwiththerestofthebatchdocumentationIfanycorrectiveactionhastobetakeninconnectionwiththecase,QAhastosignoffortheimplementationofthecorrectiveactionAcopyofthereportiskeptintheChemicallaboratoryASIlabOOSOOTreportsarekeptforatleastyears​ References​ QaICHGoodManufacturingPracticeGuideforAPI’s,step,November​ OutofspecificationlaboratoryResultsintheProductionofPharmaceuticals,PharmaceuticalsTechnology,April​ TheGoldSheet,Vol,No,October

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