FDA最新工艺验证指导书

Guidance for Industry行业指南Process Validation: GeneralPrinciples and Practices工艺验证：一般原则与规U.S. Department of Health and Human ServicesFood and Drug AdministrationCenter for Drug Evaluation and Research (CDER)Center for Biologics Evaluation and Research (CBER)Center for Veterinary Medicine (CVM)January 2024Current Good Manufacturing Practices (CGMP)Revision 1美国卫生与人类服务部食品药品管理局药物评价和讨论中心（CDER）生物制品评价和讨论中心（CBER）兽药中心（CVM）2024年1月现行药品质量生产管理规（CGMP）修订版1包含不具约束力的建议中文译稿：大学药物信息与工程讨论中心infocpier.pku.edu.cnGuidance for Industry行业指南Process Validation: GeneralPrinciples and Practices工艺验证：一般原则与规Additional copies are available from:Office of CommunicationsDivision of Drug Information, WO51, Room 220110903 New Hampshire Ave.Silver Spring, MD20993Phone: 301-796-3400; Fax: 301-847-8714druginfofda.hhs.govand/orOffice of Communication, Outreach and Development, HFM-40Center for Biologics Evaluation and ResearchFood and Drug Administration1401 Rockville Pike, Rockville, MD20852-1448(Tel) 800-835-4709 or 301-827-1800and/orCommunications Staff, HFV-12Center for Veterinary MedicineFood and Drug Administration7519 Standish Place,Rockville, MD20855(Tel) 240-276-9300.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/default.htm包含不具约束力的建议中文译稿：大学药物信息与工程讨论中心infocpier.pku.edu.cn另外的副本可从以下部门得到：马里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：20993：301-796-3400; ：301-847-8714druginfofda.hhs.gov.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm和/或马里洛克维尔市洛克维尔大道1401号HFM-40 FDA生物制品评价和讨论中心对外信息、外联与进展办公室邮政编码：20852-1448：800-835-4709 或301-827-1800.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/def...