FDA工艺验证指南的正式版本.pdf

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1、GuidanceforIndustryProcessValidation:GeneralPrinciplesandPracticesU.S.DepartmentofHealthandHumanServicesFoodandDrugAdministrationCenterforDrugEvaluationandResearch(CDER)CenterforBiologicsEvaluationandResearch(CBER)CenterforVeterinaryMedicine(CVM)January2011CurrentGoodManufacturi

2、ngPractices(CGMP)Revision1GuidanceforIndustryProcessValidation:GeneralPrinciplesandPracticesAdditionalcopiesareavailablefrom:OfficeofCommunicationsDivisionofDrugInformation,WO51,Room220110903NewHampshireAve.SilverSpring,MD20993Phone:301-796-3400;Fax:301-847-8714druginfo@fda.hhs.

3、govhttp://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htmand/orOfficeofCommunication,OutreachandDevelopment,HFM-40CenterforBiologicsEvaluationandResearchFoodandDrugAdministration1401RockvillePike,Rockville,MD20852-1448(Tel)800-835-4709or301-827-18

4、00http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htmand/orCommunicationsStaff,HFV-12CenterforVeterinaryMedicineFoodandDrugAdministration7519StandishPlace,Rockville,MD20855(Tel)240-276-9300http://www.fda.gov/AnimalVeterinary/Gu

5、idanceComplianceEnforcement/GuidanceforIndustry/default.htmU.S.DepartmentofHealthandHumanServicesFoodandDrugAdministrationCenterforDrugEvaluationandResearch(CDER)CenterforBiologicsEvaluationandResearch(CBER)CenterforVeterinaryMedicine(CVM)January2011CurrentGoodManufacturingPract

6、ices(CGMP)Revision1ContainsNonbindingRecommendationsTABLEOFCONTENTSI.INTRODUCTION.............................................................................................................1II.BACKGROUND...........................................................................

7、....................................3A.ProcessValidationandDrugQuality..........................................................................................3B.ApproachtoProcessValidation.........................................................................................

8、..........4III.STATUTORYANDREGULATORYREQUIREMEN