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 行业行业指南：指南：药品药品委托委托生产生产安排安排：质量协议：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：药品行业指南：药品委托委托生产生产安排：安排：质量质量协议协议 This guidance represents the current thinking of the Food and Drug Administration (FDA or Agency) on this topic. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. To discuss an alternative approach, contact the FDA office responsible for this guidance as listed on the title page. 本指南代表 FDA当前对此问题的看法。它并未赋予任何人以任何权力，也不对 FDA和公众具有任 何强制约束。如果你有一个替代的方法满足适用的法律法规要求，你可以使用该方法。如需对替代 方法进行讨论，请联系本指南标题页上的 FDA 官方负责人。 I. INTRODUCTION 前言前言 This guidance describes FDAs current thinking on defining, establishing, and documenting manufacturing activities of the parties involved in contract drug manufacturing subject to current good manufacturing practice (CGMP) requirements. In particular, we describe how parties involved in contract drug manufacturing can use quality agreements to d