整理后复制_Validation02_Cleaning Validation课件.ppt

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1、ValidationPart2:CleaningvalidationSupplementaryTrainingModulesonGoodManufacturingPracticesValidationObjectivesToreview:GeneralrequirementsValidationprotocolrequirementsHowtochecklimitsAnalyticalrequirementsSamplemethodsValidationWhycleaningvalidationissoimportant(1)Pharmaceuticalscan

2、becontaminatedbypotentiallydangeroussubstancesEssentialtoestablishadequatecleaningproceduresValidationWhycleaningvalidationissoimportant(2)“Particularattentionshouldbeaccordedtothevalidationof…cleaningprocedures”(WHO)“Cleaningvalidationshouldbeperformedinordertoconfirmtheeffectivenesso

3、facleaningprocedure”(PIC/S)“Thedatashouldsupportaconclusionthatresidueshavebeenreducedtoan‘acceptable’level”(FDA)PossiblecontaminantsProductresiduesCleaningagentresiduesandbreakdownAirbornematterLubricants,ancillarymaterialDecompositionresiduesBacteria,mouldandpyrogensValidationValidat

4、ionStrategyoncleaningvalidationProductcontactsurfacesAfterproductchangeoverBetweenbatchesincampaignsBracketingproductsforcleaningvalidationPeriodicre-evaluationandrevalidationValidationCleaningvalidationprotocol(1)Shouldinclude:ObjectiveofthevalidationResponsibilityforperformingandappr

5、ovingvalidationstudyDescriptionofequipmenttobeusedValidationCleaningvalidationprotocol(2)Shouldinclude:Intervalbetweenendofproductionandcleaning,andcommencementofcleaningprocedureCleaningprocedurestobeusedAnyroutinemonitoringequipmentusedNumberofcleaningcyclesperformedconsecutivelySamp

6、lingproceduresusedandrationaleSamplinglocations(clearlydefined)ValidationRecordofcleaningvalidationShouldinclude:DataonrecoverystudiesAnalyticalmethodsincludingLimitofDetectionandLimitofQuantitationAcceptancecriteriaandrationaleWhenrevalidationwillberequiredMusthavemanagementandQAinvol

7、vementManagementcommitmentandQAinvolvementValidationResultsandreportsCleaningrecordsignedbyoperator,checkedbyproductionandreviewedbyQAFinalValidationReports,includingconclusionsValidationPersonnelManualcleaningmethodsaredifficulttovalidateCannotvalidatepeople;canmeasureproficiencyMus