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Contract Manufacturing Arrangements for Drugs: Quality Agreements 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) 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This guidance describes FDA’s currentthinking on defining, establishing, anddocumenting manufacturing activitiesof the parties involved in contractdrug manufacturing subjectto current good manufacturing practice (C GMP)requirements. Inparticular, we describe how parties involved in contract drug manufacturingcan use quality agreements to delineate their manufacturing activities to ensurecompliance 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 withthe 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 ManufacturingPractice (CGMP) refers to requirements in the Federal Food, Drug, andCosmetic Act (FD&C Act),section 501(a)(2)(B), for all drugs and activepharmaceutical ingredients (APIs). Forfinished human and animal drugs,the term includes applicable requirements under 21 CFR parts 210 and 211. Forbiologics, the term includesadditional applicable requirements under 21 CFRparts 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 or drugsintended 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 materialfor investigational new drug studies(e.g., clinical trials, expandedaccess), or manufacturing of material for veterinary investigational drugs. Although this guidance does not explicitly apply tothe manufacture of investigational, developmental, or clinical trial materials, FDA believes that quality agreements can be extremely valuablein delineating the activities of all parties involvedin contract research and developmentarrangements. Many of theprinciples described in this guidancecould be applied in pre-commercial stagesof 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。虽然本指南并未明确指出适用于临床前、研发、和临床研究用原料，但FDA相信质量协议在描绘委托研发安排中所有各方活动时会极有价值。本指南中所述的许多原则可以使用于药品生命周期中商业化之前的阶段。 · Manufacturing includes processing, packing, holding,labeling operations, testing, and quality unit operations. · 生产：包括加工、包装、保存、贴标操作、检测和质量部门操作。 · A manufactureris anentity that engages in CGMP activities,including implementation ofoversight and controlsover the manufacture of drugs to ensure quality [2]. · 生产商：指从事CGMP活动，包括实施药品生产监管和控制以确保质量的实体。 · Qualityunit is defined as synonymous with the term qualitycontrol unit[3]. · 质量部门：与质量控制部门是同义词。 This guidance covers commercial manufacturingof the following categoriesof drugs: human drugs,veterinary drugs, certain combination products, biological and biotechnology products, finishedproducts, APIs, drug substances, in-process materials, and drug constituentsof combinationdrug/device products [4]. This guidancedoes not cover thefollowing typesof products: Type A medicated articles and medicatedfeed, medical devices, dietarysupplements, orhuman cells, tissues, or cellular or tissue-based productsregulated solely undersection 361 of the PublicHealth Service Actand 21 CFR part 1271. 本指南覆盖以下类型的药品商业生产：人用药、兽用药、部分药械组合产品、生物制品和生物技术药品、制剂、原料药、药用物质、在制物料以及药械组合产品中的药物成分。本指南不覆盖以下类型的产品：A类药用材料和药用饲料、医疗器械、膳食补充剂以及仅受到公共卫生服务法案第361部分和21CFR第1271部分管理人体细胞、组织和细胞/组织衍生产品。 In general, FDA’s guidancedocuments do not establish legally enforceable responsibilities. Instead, guidancesdescribe the Agency’s currentthinking on a topic and should be viewed only asrecommendations, unless specificregulatory or statutoryrequirements are cited.The use of the word should in Agency guidances means that somethingis suggested orrecommended, but not required. 一般来说，FDA的指南文件并没有法定强制力。相反，指南描述的只是当局目前对某个议题的看法，除其中所引用的法律法规要求外，其它内容应该只是作为建议来看待。SHOULD一词在当局指南中只是表示建议或推荐某事，并不是强制要求。
[1] This guidancehas been preparedby the Office of Pharmaceutical Qualityand the Officeof Compliance in the Centerfor Drug Evaluation and Research in cooperation with the Center for Biologics Evaluation and Research,the Center for Veterinary Medicine, and the Office of Regulatory Affairs at the Food and Drug Administration.
[2] See section 501 of the FD&C Act, as amended by the Food and Drug Administration Safety and Innovation Act (PublicLaw 112-144, title VII, section711). 参见FD&C法案第501部分及FDA安全和创新法案修正（公共法112-114，标题VII，711部分）
[3] For quality controlunit, see 21 CFR 210.3. 质量控制部门参见21CFR21.3.
[4] Combination product manufacturers can apply this guidance to their quality agreements because they are subjectto requirements under 21 CFR part 211 and/or21 CFR part 820 (see 21 CFR 4.3).In addition to facilitating compliance with requirements under 21 CFR part 211, manufacturers can use qualityagreements with contract facilities to demonstrate compliance, in part, with 21 CFR 820.50 (purchasing controls) andwith 21 CFR 820.80(b) (receiving acceptance activities) for combination products. 药械组合产品生产商可以在其质量协议中适用此指南，因为他们要受到21CFR第211和/或21CFR第820部分（参见21CFR4.3）要求的约束。除了有助于符合21CFR第211部分的要求外，生产商还可以与受托方使用质量协议来说明其符合组合产品的21CFR820.50（采购控制）和21CFR820.80（b）（接受可接受活动）要求。
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