FDA行业指南 委托生产质量协议 中英文.pdf

FDA Guidance for Industry: ContractManufacturing ArrangementsforDrugs: QualityAgreements Page 1 / 21 Contract Manufacturing Arrangements for Drugs: Quality Agreements Guidance for Industry 行业指南：药品委托生产安排：质量协议 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) November 2016 Pharmaceutical Quality/Manufacturing Standards (CGMP) FDA 行业指南：药品委托生产安排：质量协议 翻译：Julia FDA Guidance for Industry: ContractManufacturing ArrangementsforDrugs: QualityAgreements Page 2 / 21 Guidance for Industry Additional copies are availablefrom: Office of Communications, Division of Drug Information Centerfor Drug Evaluation and Research Food and Drug Administration 10001 New Hampshire Ave., Hillandale Bldg., 4th Floor Silver Spring, MD 20993-0002 Phone: 855-543-3784 or 301- 796-3400; Fax: 301-431-6353 Email: druginfo@ /Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm and/or Office of Communication, Outreach and Development Centerfor Biologics Evaluation and Research Food and Drug Administration 10903 New Hampshire Ave., Bldg. 71, Room 3128 Silver Spring, MD 20993-0002 Phone: 800-835-4709 or 240-402-8010 Email: