FDA行业指南委托生产质量协议中英文

Contract Manufacturing Arrangements for Drugs: Quality AgreementsGuidance 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 AdministrationCenter for Drug Evaluation and Research (CDER)Center for Biologics Evaluation and Research (CBER)Center for Veterinary Medicine (CVM)November 2016Pharmaceutical Quality/Manufacturing Standards (CGMP)Guidance for IndustryAdditional copies are available from:Office of Communications, Division of Drug Information Center for Drug Evaluation and ResearchFood and Drug Administration10001 New Hampshire Ave., Hillandale Bldg., 4th Floor Silver Spring, MD 20993-0002Phone: 855-543-3784 or 301-796-3400; Fax: 301-431-6353Email: druginfo@/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htmand/orOffice of Communication, Outreach and Development C enter for Biologics Evaluation and ResearchFood and Drug Administration10903 New Hampshire Ave., Bldg. 71, Room 3128S ilver Spring, MD 20993-0002Phone: 800-835-4709 or 240-402-8010Email: ocod@/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htmand/orPolicy and Regulations Staff, HFV-6Center for Veterinary Medicine Food and Drug Administration7519 Standish Place, Rockville, MD 20855/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/default.htmU.S. Department of Health and Human Services Food and Drug AdministrationCenter for Drug Evaluation and Research (CDER)Center for Biologics Evaluation and Research (CBER)Center for Veterinary Medicine (CVM)November 2016Pharmaceutical Quality/Manufacturing Standards (CGMP)TABLE OF CONTENTS 目录TABLE OF CONTENTS目录 (3)I. INTRODUCTION前言 (4)II. DEFININGTHEWHO AND WHAT OFCONTRACT MANUFACTURING指定委托生产的人和事 (6)III. RESPONSIBILITIES OFPARTIES INVOLVED IN CONTRACTMANUFACTURING委托生产所涉及各方的职责7 IV. DOCUMENTINGCGMPACTIVITIES IN QUALITYAGREEMENTS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？18B.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20VI. RECOMMENDATIONS建议 (21)Contract Manufacturing Arrangements for Drugs:QualityAgreementsGuidance 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 Administration (FDA or Agency) onthis 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 t itle 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This guidance describes FDA’ｓ 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 delineate theirmanufacturing activities to ensure compliance with CGMP.本指南讲述了FDA当前对于受到CGMP约束的药品委托生产所涉及各方如何定义、设立和记录生产活动的看法，尤其是药品委托各方如何使用质量协议来描绘其生产活动，以确保符合CGMP。

For purposes of this guidance, we use certain terms with the following specific meanings:在本指南中，我们使用了特定的术语，其在指南中的含义如下：Current Good Manufacturing Practice (CGMP) refers to requirements in the FederalFood, Drug, and Cosmetic Act (FD&C Act), section 501(a)(2)(B), for all drugs andactive pharmaceutical ingredients (APIs). For finished human and animal drugs, the termincludes applicable requirements under 21 CFR parts 210 and 211. For biologics, theterm includes additional applicable requirements under 21 CFR parts 600-680.CGMP：指FD&C法案第501（a）(2)(B)中对所有制剂和原料药的要求。

对于人用和兽用制剂，该术语包括21CFR第210和211部分中适用的要求。

对于生物制品，术语还包括21CFR第600-680部分中适用的额外要求。

Commercial manufacturing refers to manufacturing processes that result in a drug ordrugs intended to be marketed, distributed, or sold.商业化生产：指准备用于上市销售的药品的生产过程。

Commercial manufacturing does not include research and development activities,manufacturing of material for investigational new drug studies (e.g., clinical trials,expanded access), or manufacturing of material for veterinary investigational drugs.1This guidance has been prepared by the Office of Pharmaceutical Quality and the Office of Compliance in theCenterCenter forfor Drug Evaluation and Research in cooperation with the Center for Biologics Evaluation and Research, theVeterinary Medicine, and the Office of Regulatory Affairs at the Food and Drug Administration.Although this guidance does not explicitly apply to the manufacture of investigational,developmental, or clinical trial materials, FDA believes that quality agreements can beextremely valuable in delineating the activities of all parties involved in contract researchand development arrangements. Many of the principles described in this guidance couldbe applied in pre-commercial stages of the pharmaceutical life cycle.商业化生产并不包括研发活动、临床新药研究用原料的生产（例如，临床试验、扩大使用面），以及兽用临床药所用原料的生产。