2011 FDA行业指南.工艺验证(中英文对照)-一般原则与规范.pdf

Guidance for Industry 行业指南 Process Validation: General Principles and Practices 工艺验证：一般原则与规范 U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Biologics Evaluation and Research (CBER) Center for Veterinary Medicine (CVM) January 2011 Current 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 Guidance for Industry 行业指南 Process Validation: General Principles and Practices 工艺验证：一般原则与规范 Additional copies are available from: Office of Communications Division of Drug Information, WO51, Room 2201 10903 New Hampshire Ave. Silver Spring, MD 20993 Phone: 301-796-3400; Fax: 301-847-8714 druginfo@ /Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm and/or Office of Communication, Outreach and Development, HFM-40 Center for Biologics Evaluation and Research Food and Drug Administration 1401 Rockville Pike, Rockville, MD 20852-1448 (Tel) 800-835-470