FDA灭菌工艺验证资料指南(英文)

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1、GuidanceforIndustryfortheSubmissionDocumentationforSterilizationProcessValidationinApplicationsforHumanandVeterinaryDrugProductsCenterforDrugEvaluationandResearch(CDER)CenterforVeterinaryMedicine(CVM)November1994CMC2TABLEOFCONTENTSI.INTRODUCTION.......................

2、........................1A.Purpose.................................................1B.DocumentingSterilizationProcessValidation...................2C.Remarks................................................2II.INFORMATIONFORTERMINALMOISTHEATSTERILIZATIONPROCESSES.......

3、..........................................3A.DescriptionoftheProcessandProduct........................31.TheDrugProductandContainer-ClosureSystem..........32.TheSterilizationProcess..............................33.TheAutoclaveProcessandPerformanceSpecifications.....44

4、.AutoclaveLoadingPatterns............................45.MethodsandControlstoMonitorProductionCycles.........46.RequalificationofProductionAutoclaves..................47.Reprocessing.......................................4B.ThermalQualificationoftheCycle...............

5、.............41.HeatDistributionandPenetrationStudies.................42.ThermalMonitors....................................53.TheEffectsofLoadingonThermalInput..................54.InformationIncludedintheBatchRecord.................5C.MicrobiologicalEfficacyoftheCycl

6、e..........................51.IdentificationandCharacterizationofBioburdenOrganisms...62.SpecificationsforBioburden...........................63.Identification,Resistance,andStabilityofBiologicalIndicators..........................................64.TheResistanceofthe

7、BiologicalIndicatorRelativetoThatofBioburden........................................65.MicrobiologicalChallengeStudies.......................7D.MicrobiologicalMonitoringoftheEnvironment...................7E.Container-ClosureandPackageIntegrity........................7

8、1.SimulationoftheStressesFromProcessing................72.DemonstrateIntegrityFollowingtheMaximumExposure......83.MultipleBa