SoltorisManagement Consultants, Inc. 洛施德企业管理咨询（上海）有限公司 第1页 / 共25页 www.soltoris.com, Soltoris Management Consultants, Inc. infosoltoris.com Analytical Procedures and Methods Validation for Drugs and Biologics 药品和生物制品分析方法验证药品和生物制品分析方法验证 Guidance for Industry 行业指南行业指南 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 SoltorisManagement Consultants, Inc. 洛施德企业管理咨询（上海）有限公司 第2页 / 共25页 www.soltoris.com, Soltoris Management Consultants, Inc. infosoltoris.com 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: druginfofda.hhs.gov http:/www.fda.gov/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: ocodfda.hhs.gov http:/www.fda.gov/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 SoltorisManagement Consultants, Inc. 洛施德企业管理咨询（上海）有限公司 第3页 / 共25页 www.soltoris.com, Soltoris Management Consultants, Inc. infosoltoris.com TABLE OF CONTENTS I. INTRODUCTION. 1 II. BACKGROUND. 2 III. ANALYTICAL METHODS DEVELOPMENT. 3 IV. CONTENT OF ANALYTICAL PROCEDURES. 4 A. Principle/Scope.4 B. Apparatus/Equipment .4 C. Operating Parameters .4 D. Reagents/Standards .4 E. Sample Preparation .5 F. Standards Control Solution Preparation.5 G. Procedure.5 H. System Suitability .5 I. Calculations .5 J. Data Reporting.6 V. REFERENCE STANDARDS AND MATERIALS. 6 VI. ANALYTICAL METHOD VALIDATION . 7 A. Noncompendial Analytical Procedures.7 B. Validation Characteristics.7 C. Compendial Analytical Procedures.8 VII. STATISTICAL ANALYSIS AND MODELS . 8 A. Statistics .8 B. Models.9 VIII. LIFE CYCLE MANAGEMENT OF ANALYTICAL PROCEDURES . 9 A. Revalidation.10 B. Analytical Method