洛施德GMP咨询 - FDA行业指南-药物和生物制品分析方法验证.pdf

SoltorisManagement Consultants, Inc. 洛施德企业管理咨询（上海）有限公司 Analytical Procedures and Methods Validation for Drugs and Biologics 药品和生物制品分析方法验证 Guidance for Industry 行业指南 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) July 2015 Pharmaceutical Quality/CMC 第1 页 / 共25 页 , Soltoris Management Consultants, Inc. info@ SoltorisManagement Consultants, Inc. 洛施德企业管理咨询（上海）有限公司 Analytical Procedures and Methods Validation for Drugs and Biologics Guidance for Industry Additional copies are available from: Office of Communications, Division of Drug Information Center for Drug Evaluation and Research Food and Drug Administration 10001 New Hampshire Ave., Hillandale Bldg., 4th Floor Silver Spring, MD 20993 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 Center for Biologics Evaluation and Research Food and Drug Administration 10903 New Hampshire Ave., Bldg. 71, Room 3128 Silver Spring, MD 20993 Phone: 800-835-4709 or 240-402-7800 Email: ocod@ /BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm 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) July 2015 Pharmaceutical Quality/CMC 第2 页 / 共25 页