FDA行业指南: 委托生产质量协议
发布时间：2016-11-30
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INTRODUCTION 前言
This guidance describes FDA's current thinking on defining, establishing, and documenting manufacturing activitiesof 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 their manufacturing 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 Federal Food, Drug, and Cosmetic Act (FD&C Act), section 501(a)(2)(B), for all drugs and active pharmaceutical ingredients (APIs). For finished human and animal drugs, the term includes applicable requirements under 21 CFR parts 210 and 211. For biologics, the term includes additional 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 drugs 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. Although this guidance does not explicitly apply to the manufacture of investigational, developmental, or clinical trial materials, FDA believes that quality agreements can be extremely valuablein delineating the activities of all parties involved in contract research and development arrangements. Many of the principles described in this guidance could be 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。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 of oversight and controls over 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。
Quality unit is defined as synonymous with the term quality control unit[3].
质量部门：与质量控制部门是同义词。
This guidance covers commercial manufacturing of the following categoriesof drugs: human drugs, veterinary drugs, certain combination products, biological and biotechnology products, finished products, APIs, drug substances, in-process materials, and drug constituents of combination drug/device products[4]. This guidance does not cover the following types of products: Type A medicated articles and medicated feed, medical devices, dietary supplements, or human cells, tissues, or cellular or tissue-based products regulated solely under section 361 of the Public Health 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 guidance documents do not establish legally enforceable responsibilities. Instead, guidances describe the Agency's current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidances means that something is suggested or recommended, 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。
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