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FDA工艺验证指南的正式版本.pdf

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GuidanceforIndustry ProcessValidation:General PrinciplesandPractices U.S.DepartmentofHealthandHumanServices FoodandDrugAdministration CenterforDrugEvaluationandResearch(CDER) CenterforBiologicsEvaluationandResearch(CBER) CenterforVeterinaryMedicine(CVM) January2011 CurrentGoodManufacturingPractices(CGMP) Revision1 GuidanceforIndustry ProcessValidation:General PrinciplesandPractices Additionalcopiesareavailablefrom: OfficeofCommunications DivisionofDrugInformation,WO51,Room2201 10903NewHampshireAve. SilverSpring,MD20993 Phone:301-796-3400;Fax:301-847-8714 druginfo@fda.hhs.gov http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm and/or OfficeofCommunication,OutreachandDevelopment,HFM-40 CenterforBiologicsEvaluationandResearch FoodandDrugAdministration 1401RockvillePike,Rockville,MD20852-1448 (Tel)800-835-4709or301-827-1800 http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm and/or CommunicationsStaff,HFV-12 CenterforVeterinaryMedicine FoodandDrugAdministration 7519StandishPlace, Rockville,MD20855 (Tel)240-276-9300 http://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/default.htm U.S.DepartmentofHealthandHumanServices FoodandDrugAdministration CenterforDrugEvaluationandResearch(CDER) CenterforBiologicsEvaluationandResearch(CBER) CenterforVeterinaryMedicine(CVM) January2011 CurrentGoodManufacturingPractices(CGMP) Revision1 ContainsNonbindingRecommendations TABLEOFCONTENTS I.INTRODUCTION.............................................................................................................1 II.BACKGROUND...............................................................................................................3 A.ProcessValidationandDrugQuality..........................................................................................3 B.ApproachtoProcessValidation.....................................