MHRA OOS指南

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1、SafeguardingpublichealthOutOfSpecificationInvestigations.©CrowncopyrightHowtoUseTheInvestigationofOutOfSpecificationFlowchartNavigation:ThisfileshouldbeviewedusingtheSlideshowView.ClickingonthoseProcessStepboxeswithaheavyborderinaprocessflowslidewilltakeyoutoanewsl

2、idewithfurtherdetailaboutthatstep.EachstephasalinktoreturntotheOverviewSlide.ThismovestheslideupwardsThismovestheslidedownwardstothenextslideSlide2©CrowncopyrightLaboratoryAnalysisOOS(OOT)ResultSatisfactoryPhaselaInvestigationPhaseIbInvestigationManufacturingPhaseI

3、IInvestigationInvestigationPhaseIIIInvestigationProductImpactAssessmentBatchDispositionSlide3©CrowncopyrightLaboratoryAnalysis•Investigationsof"OutofSpecification(OOS)/OutofTrend(OOT)/Atypical-results"havetobedoneincasesof:-Batchreleasetestingandtestingofstartingma

4、terials.-In-ProcessControltesting:ifdataisusedforbatchcalculations/decisionsandifinadossierandonCertificatesofAnalysis.-Stabilitystudiesonmarketedbatchesoffinishedproductsandoractivepharmaceuticalingredients,ongoing/followupstability(nostresstests)-Previousreleased

5、batchusedasreferencesampleinanOOSinvestigationshowingOOSorsuspectresults.-Batchesforclinicaltrials.•Allsolutionsandreagentsmustberetaineduntilalldatahasbeensecondpersonverifiedasbeingwithinthedefinedacceptancecriteria.•Pharmacopoeiahavespecificcriteriaforadditional

6、analysesofspecifictests(i.e.dissolutionlevelspecificationforS1,S2&S3testing;Uniformityofdosageunitsspecificationfortestingof20additionalunits;SterilityTesting).Howeverifthesampletestcriteriaisusuallythefirstleveloftestingandasamplehastobetestedtothenextlevelthissho

7、uldbeinvestigatedasitisnotfollowingthenormaltrend.•TheOOSprocessisnotapplicableforIn-processtestingwhiletryingtoachieveamanufacturingprocessend-pointi.e.adjustmentofthemanufacturingprocess.(e.g.pH,viscosity),andforstudiesconductedatvariableparameterstochecktheimpac

8、tofdrift(e.g.processvalidationatvariableparameters).Slide4Home©CrowncopyrightOOS/OOT/AtypicalResult•Out-of-Specification(OOS)Result–testresulttha