SOP for OOS and OOT(中英文)

1.Purpose目的Todescribetheproceduresandresponsibilitiesforhandlingofresults,generatedinMicrobiologicalLaboratory,whichareeitherOOS(OutofSpecification)orOOT(OutofTrend).描述微生物实验室中产生的OOS（超标）或OOT（超趋势）结果的处理程序及职责。2.Scope范围2.1General总则OOS/OOTresultsobtainedfromanalysisofAPI’s,finishedproductsandrawmaterialincludingwaterusedintheproductionbutwiththefollowingexceptions.OOS/OOT结果从原料药、成品和包括生产用水在内的原料的分析中得到，以下情况例外。2.2Exceptionsandspecialcases例外和特殊情况2.2.1Non-confirmingpositiveandnegativecontrols非确认的阳性和阴性对照Analyseswhereresultsfrompositiveand/ornegativecontrolsarenotaffirmativecanberepeatedwithoutfurtherinvestigation.Thelaboratorydocumentationforthefailedtestmustincludeanoteasexplanation.Nofurtherreporting.阳性和阴性对照的结果分析是不肯定的，可以被重复测定，不需要进一步调查。失败的测试应在实验室文件中被解释说明。不需要进一步报告。2.2.2Discontinuationofanalysis分析的中止Analysiscanbediscontinuedduetoerrorsintestingprocedureorproblemswithequipmentuntilthetimeofincubation.Thelaboratorydocumentationforthefailedtestmustincludeanoteasexplanation.Nofurtherreporting.由于检验程序的错误或者仪器的问题，可以中止分析。失败的测试应在实验室文件中被解释说明。不需要进一步报告。2.2.3Stabilitysamples稳定性样品ThefirsttimeasampleresultexceedsalimititisinvestigatedaccordingtothisSOP.Theretestresultcanprovideinformationonwhethertheoriginalresultisnotrepresentativeofthebatchofsamplestakenoutforstability.Providedthattheresultisnotinvalidated,confirmativeOOS/OOTresultslaterinthestabilityperiodwillonlybereportedinthedeviationhandlingsystem.当样品结果首次超限时，按照此SOP进行调查。复测结果提供信息，证明是否原始结果对稳定性取样批次不具代表性。假如结果并非无效，那么在接下来的稳定性阶段中的确定的OOS/OOT结果将仅在偏差处理系统中被报告。2.2.4Intermediatesfromproduction生产过程中的中间体IngeneralOOS/OOTresultsarenotinvestigatedaccordingtothisprocedureunlessotherwisespecifiedinotherrelevantdocument.Ifsospecified,thefirsttime(definedasexceedingoflimitafter3normaltestresultsforthesamplepoint)asampleresultexceedsalimititisinvestigatedaccordingtothisSOP.Theinvestigationislikelytoincluderesultsfromsuccessivesamplesfromsameproducttype.WhentheOOS/OOTinvestigationiscompleteandprovidedthattheresultisnotinvalidated,confirmativeOOS/OOTresultsobtainedonsubsequentsamplesfromsameproducttypewillonlybereportedinthedeviationsystem.一般来说，除非有另外关联文件说明，OOS/OOT结果不根据这个工序进行调查。如果这样规定了，样品结果首次超限（定义为相同取样点的三次常规检测结果超限）应根据此SOP进行调查。调查可能包括同类产品的连续取样结果。当OOS/OOT调查完成，假如结果并非无效，那么随后取的样品的确定的OOS/OOT结果将仅在偏差系统中被报告。2.2.5Environmentalmonitoringsamples环境监测样品AredealtwithatperiodicmeetingsbetweenQRTandtheresponsiblemanager(productionorlaboratory)andOOS/OOTresultsarereportedbyQRT.环境监测样品在QRT与相关责任管理者（生产和实验室）之间的阶段性会议中被处理，QRT报告OOS/OOT结果。2.2.6Positivesterilitytest阳性无菌试验OOSwillberegisteredaccordingtothisprocedurebutinvestigatedandreportedinaccordancewithSOPforinvestigationofpositivesterilitytest.OOS应根据此程序记录，调查和报告应根据阳性无菌试验调查SOP进行。2.2.7Water,usedinproduction生产用水Thefirsttime(definedasexceedingoflimitafter3normaltestresultsforthesamplepoint)asampleresultexceedsalimititisinvestigatedaccordingtothisSOP.QRTdecidesifadditionalsamplingisrequired.Theinvestigationislikelytoincluderesultsfromsuccessivesamplesfromsamesamplingpoint.WhentheOOS/OOTinvestigationiscompleteandprovidedthattheresultisnotinvalidated,confirmativeOOS/OOTresultsobtainedonsubsequentsamplesfromsamepositionwillonlybereportedinthedeviationsystem.样品结果首次超限（定义为相同取样点的三次常规检测结果超限）应根据此SOP进行调查。QRT决定是否需要额外取样。调查可能包括相同取样点的连续取样结果。当OOS/OOT调查完成，假如结果并非无效，那么随后取的样品的确定的OOS/OOT结果将仅在偏差系统中被报告。2.2.8Dissolutiontest溶解试验ResultsarenotconsideredOOS/OOTuntiltheinterpretationcriteriaincurrentUSP711isexceeded.在解释的标准超过现行的USP711前，结果不被作为OOS/OOT。3.Responsibilities职责3.1Laboratorytechnicians实验室技术人员IdentifyOOS/OOTresultsandreport,withinthefollowingworkingday,tothelaboratorymanagerorsubstitute.确认OOS/OOT结果和报告，在接下来的一个工作日内，报告给实验室经理或者代理。Ifpossiblethelaboratorytechniciansmustassurethattestrelevantmaterial(f.e.g.samplesolutions)isnotdiscardedbeforetheinvestigationiscompleted.如果可能的话，实验室技术人员须确保在调查完成前，相关的检测物料（例如样品液）不被丢弃。EquipmentsuspectedtobethecauseofanOOS/OOTshouldbequarantinedduringtheperiodoftheinvestigation.涉嫌引起OOS/OOT的设备，在调查期间应避免使用。FillingoutthepartoftheOOS/OOTreportrelatedtothelaboratoryinvestigation.填写涉及实验室调查的OOS/OOT部分。3.2Laboratorymanagerorsubstitute实验室经理或代理NotifyReleaseTeamimmediately.直接通知放行小组Initiateandassureacompleteinvestigationofactivitiesinthelaboratory.启动并确保一个完整的实验室调查。Initiateretestingorreanalysis.启动复测或再分析。Initiateandcomplete(incl.signingoff)laboratoryinvestigationreport.启动并完成（包括最终签字）实验室调查报告。Intheeventofalaboratoryinvestigationwherenolaboratoryerrorisfound,contactQRTtoassurethatrelevantinformationispassedontotheproductioninordertoinvestigateapossibleprocessrelatederror.如果调查显示没有实验室误差，联系QRT，确保相关信息传送给生产部门，调查可能的工艺相关的错误。SendthesignedreporttoQAforapproval.发送已签字的报告给QA批准。4.Definitions定义4.1Result结果Itisthefinalqualitativeorquantitativevalue,determinedby,anapprovedtestmethod.是由一个批准的检测方法确定的最终的定性或定量值。4.1.1Ifthetestmethodrequiresmultipledeterminations(LAL-test,TotalViableCount,microbiologicalpotency,ID),itisonlythefinalresult,whichisevaluatedinaccordancewiththespecification.如果检测方法要求多种测定（LAL检测，总活菌数，微生物效价，ID），它仅仅是根据法规评估的最终结果。4.1.2Incaseswheremultipledeterminationsshowlargervariations/deviationsthanthelimitdefined