GuidanceforIndustry行业指南ProcessValidation:GeneralPrinciplesandPractices工艺验证:一般原则与规范U.S.DepartmentofHealthandHumanServicesFoodandDrugAdministrationCenterforDrugEvaluationandResearch(CDER)CenterforBiologicsEvaluationandResearch(CBER)CenterforVeterinaryMedicine(CVM)January2011CurrentGoodManufacturingPractices(CGMP)Revision1美国卫生与人类服务部食品药品管理局药物评价和研究中心(CDER)生物制品评价和研究中心(CBER)兽药中心(CVM)2011年1月现行药品质量生产管理规范(CGMP)修订版1包含不具约束力的建议中文译稿:北京大学药物信息与工程研究中心info@cpier.pku.edu.cnGuidanceforIndustry行业指南ProcessValidation:GeneralPrinciplesandPractices工艺验证:一般原则与规范Additionalcopiesareavailablefrom:OfficeofCommunicationsDivisionofDrugInformation,WO51,Room220110903NewHampshireAve.SilverSpring,MD20993Phone:301-796-3400;Fax:301-847-8714druginfo@fda.hhs.govwww.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htmand/orOfficeofCommunication,OutreachandDevelopment,HFM-40CenterforBiologicsEvaluationandResearchFoodandDrugAdministration1401RockvillePike,Rockville,MD20852-1448(Tel)800-835-4709or301-827-1800www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htmand/orCommunicationsStaff,HFV-12CenterforVeterinaryMedicineFoodandDrugAdministration7519StandishPlace,Rockville,MD20855(Tel)240-276-9300www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/default.htm包含不具约束力的建议中文译稿:北京大学药物信息与工程研究中心info@cpier.pku.edu.cn另外的副本可从以下部门得到:马里兰州银泉市新罕布什尔大道10193号2201室药品信息处,对外信息办公室,邮政编码:20993电话:301-796-3400;传真:301-847-8714druginfo@fda.hhs.govwww.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm和/或马里兰州洛克维尔市洛克维尔大道1401号HFM-40FDA生物制品评价和研究中心对外信息、外联与发展办公室邮政编码:20852-1448电话:800-835-4709或301-827-1800www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm和/或马里兰州洛克维尔市StandishPlace7519号食品药品管理局兽药中心HFV-12通讯处,邮政编码:20885电话:240-276-9300www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/default.htmU.S.DepartmentofHealthandHumanServicesFoodandDrugAdministrationCenterforDrugEvaluationandResearch(CDER)CenterforBiologicsEvaluationandResearch(CBER)CenterforVeterinaryMedicine(CVM)January2011CurrentGoodManufacturingPractices(CGMP)Revision1美国卫生与人类服务部食品药品管理局药物评估和研究中心(CDER)生物制品评估和研究中心(CBER)兽药中心(CVM)2011年1月现行药品质量生产管理规范(CGMP)修订版1包含不具约束力的建议中文译稿:北京大学药物信息与工程研究中心info@cpier.pku.edu.cnTableofContents目录I.INTRODUCTION........................................................................................................................................1一.简介..........................................................................................................................................................1II.BACKGROUND.........................................................................................................................................3二.背景..............................................................................................................................................