FDA Guidance for Industry: Contract Manufacturing Arrangements for Drugs: Quality Agreements Page 1 / 21 FDA 行业 指南 ： 药品 委托 生 产 安排 ： 质量 协议 翻译 ： Julia 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 Guidance for Industry: Contract Manufacturing Arrangements for Drugs: Quality Agreements Page 2 / 21 FDA 行业 指南 ： 药品 委托 生 产 安排 ： 质量 协议 翻译 ： Julia 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 20993-0002 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 20993-0002 Phone: 800-835-4709 or 240-402-8010 Email: ocodfda.hhs.gov http:/www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm and/or Policy and Regulations Staff, HFV-6 Center for Veterinary Medicine Food and Drug Administration 7519 Standish Place, Rockville, MD 20855 http:/www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/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) Center for Veterinary Medicine (CVM) November 2016 Pharmaceutical Quality/Manufacturing Standards (CGMP) FDA Guidance for Industry: Contract Manufacturing Arrangements for Drugs: Quality Agreements Page 3 / 21 FDA 行业 指南 ： 药品 委托 生 产 安排 ： 质量 协议 翻译 ： Julia TABLE OF CONTENTS 目录 TABLE OF CONTENTS 目录 . 3 I. INTRODUCTION 前言 . 4 II. DEFINING THE WHO AND WHAT OF CONTRACT MANUFACTURING 指定委托生产的人和事 . 6 III. RESPONSIBILITIES OF PARTIES INVOLVED IN CONTRACT MANUFACTURING 委托生产所涉及各方的职责 7 IV. DOCUMENTING CGMP ACTIVITIES IN QUALITY AGREEMENTS 在质量协议中记录 CGMP 活动 . 10 A. What Is a Quality Agreement? 什么是质量协议？ . 10 B. Elements of a Quality Agreement 质量协议的要素 . 11 V. ILLUSTRATIVE SCENARIOS 案例 . 17 A. Owners and Contract Facilities Are Both Responsible for CGMP 所有者和受托场所是否都对 CGMP负责？ 18 B. CGMPs Apply to all Contract Facilities, Including Analytical Testing Laboratories 适用于所有合同场所，包括分析化验室的 CGMP . 19 C. Owners and Contract Facilities Perform Change Control Activities 所有者和受托方实施变更控制活动20 VI. RECOMMENDATIONS 建议 . 21 FDA Guidance for Industry: Contract Manufacturing Arrangements for Drugs: Quality Agreements Page 4 / 21 FDA 行业 指南 ： 药品 委托 生 产 安排 ： 质量 协议 翻译 ： Julia Contract Manufacturing Arrangements for Drugs: Quality Agreements Guidance for Industry1 行业指南：药品 委托 生产 安排： 质量 协议 This guidance represents the current thinking of the Food and Drug Administra