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1、ValidationPart2: CleaningvalidationSupplementaryTrainingModuleson GoodManufacturingPracticesValidationObjectivesToreview:GeneralrequirementsValidationprotocolrequirementsHowtochecklimitsAnalyticalrequirementsSamplemethodsValidationWhycleaningvalidationissoimportant(1)Pharmaceuticalscan
2、becontaminatedbypotentiallydangeroussubstancesEssentialtoestablishadequatecleaningproceduresValidationWhycleaningvalidationissoimportant(2)“Particularattentionshouldbeaccordedtothevalidationof…cleaningprocedures”(WHO)“Cleaningvalidationshouldbeperformedinordertoconfirmtheeffectivenesso
3、facleaningprocedure”(PIC/S)“Thedatashouldsupportaconclusionthatresidueshavebeenreducedtoan‘a(chǎn)cceptable’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
