1、1美国 FDA CGMP 英汉对照版Subpart A-General Provisions 211.1 Scope a) The regulations in this part contain the minimum current good manufacturing practice for preparation of drug products for administration to humans or animals. b) The current good manufacturing practice regulations in this chapter, as they
2、 pertain to drug products, and in parts 600 through 680 of this chapter, as they pertain to biological products for human use, shall be considered to supplement, not supersede, the regulations in this part unless the regulations explicitly provide otherwise. In the event it is impossible to comply w
3、ith applicable regulations both in this part and in other parts of this chapter or in parts 600 through 680 of this chapter, the regulation specifically applicable to the drug product in question shall supersede the regulation in this part. c) Pending consideration of a proposed exemption, published
4、 in the Federal Register of September 29, 1978, the requirements in this part shall not be enforced for OTC drug products if the products and all their ingredients are ordinarily marketed and consumed as human foods, and which products may also fall within the legal definition of drugs by virtue of
5、their intended use. Therefore, until further notice, regulations under part 110 of this chapter, and where applicable, parts 113 to 129 of this chapter, shall be applied in determining whether these OTC drug products that are also foods are manufactured, processed, packed, or held under current good
6、 manufacturing practice. 211.3 Definitions.The definitions set forth in 210.3 of this chapter apply in this part.A总则2111 范围（a） 本部分的条例包含人用或兽用药品制备的现行最低限度的药品生产管理规范（GMP） 。（b） 在本章里的这些针对药品的现行 GMP 条例和本章 600680 部分的所有针对人用生物制品的现行 GMP 条例，除非明确另有说明外，应认为是对本部分条例的补充，而不是代替。本章其他部分或本章600680g 各部分均可适用的条例，前部分的条例可以代替本部分条例
7、。（c） 在考虑经提议的，发表在 1978 年 9 月 29 日联邦注册表（FR）上一项免除时，若产品及其所有成分是以人用物品形式作一般销售和消费，且这些产品根据其预期用途，亦可列入药品的范围，则不应对这些非处方药（OTC）实施本部分条例，直至进一步的通知为止。本章 110部分和 113 至 119 部分的条例用于鉴别这些亦是食品的 OTC 药品是否按照 GMP 的要求生产、加工、包装贮存。2113 定义本章 2113 中的定义使用于本部分。good manufacturing practice ( GMP ) 良好的生产管理规范over-the-counter （OTC） 人用非处方药per
8、tain 适合，属于 explicitly 明白地，确切地supersede 代替，取代，延期 exemption 解除，免除，免税2Subpart B-Organization and Personnel 211.22 Responsibilities of quality control unit.a) There shall be a quality control unit that shall have the responsibility and authority to approve or reject all components, drug product containe
9、rs, closures, in-process materials, packaging material, labeling, and drug products, and the authority to review production records to assure that no errors have occurred or, if errors have occurred, that they have been fully investigated. The quality control unit shall be responsible for approving
10、or rejecting drug products manufactured, processed, packed, or held under contract by another company.b) Adequate laboratory facilities for the testing and approval (or rejection) of components, drug product containers, closures, packaging materials, in-process materials, and drug products shall be
11、available to the quality control unit.c) The quality control unit shall have the responsibility for approving or rejecting all procedures or specifications impacting on the identity, strength, quality, and purity of the drug product.d) The responsibilities and procedures applicable to the quality co
12、ntrol unit shall be in writing; such written procedures shall be followed.B 组织与人员21122 质量控制部门的指责（a） 本部门有批准和拒收所有成分、药品包装容器、密封件、中间体、包装材料、标签及药品的职责与权力。复查生产记录的权力，保证不产生差错，或若发生差错，保证他们充分调查这些差错。本部门负责根据合同，批准或拒收由其他公司生产、加工、包装或贮存的药品。（b） 适当的实验室检验设备、批准（或拒收）的各种成分、药品容器、密封件、包装材料及药品，质量控制部门室可以获得的。（c） 本部门由批准或驳回影响药品的均一性、效
13、价或含量、质量及纯度的所有程序或规格标准的职责。（d） 适用于本部门的职责与程序，应成文字材料，并应遵循。Authority 权威，威信，权力，授权 closure 关闭，使终止，密封件in-process materials 中间体3 211.25 Personnel qualifications.(a) Each person engaged in the manufacture, processing, packing, or holding of a drug product shall have education, training, and experience, or any
14、combination thereof, to enable that person to perform the assigned functions. Training shall be in the particular operations that the employee performs and in current good manufacturing practice (including the current good manufacturing practice regulations in this chapter and written procedures req
15、uired by these regulations) as they relate to the employees functions. Training in current good manufacturing practice shall be conducted by qualified individuals on a continuing basis and with sufficient frequency to assure that employees remain familiar with CGMP requirements applicable to them.(b
16、) Each person responsible for supervising the manufacture, processing, packing, or holding of a drug product shall have the education, training, and experience, or any combination thereof, to perform assigned functions in such a manner as to provide assurance that the drug product has the safety, id
17、entity, strength, quality, and purity that it purports or is represented to possess.(c) There shall be an adequate number of qualified personnel to perform and supervise the manufacture, processing, packing, or holding of each drug product.21125 人员资格a) 每位从事药品生产、加工、包装或仓贮工作的人员，应接受培训、教育及有实践经验，完成委派的各项职务
18、。培训是按照现行 GMP（包括本章的现行 GMP 条例和这些条例要求的成文程序）中涉及雇员的内容。邀请合格人员指导，并连续多次培训，保证雇员熟悉现行GMP（ CGMP）对他们的要求。b) 负责监督药品的生产、加工、包装或仓贮工作的每一个人员，应受过教育、培训及有经验，完成委派的各项职务。以此作为提供药品具有安全性、均一性、效价或含量、质量及纯度的保证。c) 有足够量执行和监督每种药品的生产、加工、包装或仓贮的合格人员。thereof 在其中，关于 的，相关地current good manufacturing practice （CGMP）现行 GMPsupervise 监督，管理，指导pur
19、ports 声称. 4 211.28 Personnel responsibilities.(a) Personnel engaged in the manufacture, processing, packing, or holding of a drug product shall wear clean clothing appropriate for the duties they perform. Protective apparel, such as head, face, hand, and arm coverings, shall be worn as necessary to
20、protect drug products from contamination.(b) Personnel shall practice good sanitation and health habits.(c) Only personnel authorized by supervisory personnel shall enter those areas of the buildings and facilities designated as limited-access areas.(d) Any person shown at any time (either by medica
21、l examination or supervisory observation) to have an apparent illness or open lesions that may adversely affect the safety or quality of drug products shall be excluded from direct contact with components, drug product containers, closures, in-process materials, and drug products until the condition
22、 is corrected or determined by competent medical personnel not to jeopardize the safety or quality of drug products. All personnel shall be instructed to report to supervisory personnel any health conditions that may have an adverse effect on drug products. 211.34 Consultants.Consultants advising on
23、 the manufacture, processing, packing, or holding of drug products shall have sufficient education, training, and experience, or any combination thereof, to advise on the subject for which they are retained. Records shall be maintained stating the name, address, and qualifications of any consultants
24、 and the type of service they provide. 21128 人员职责a) 从事药品生产、加工、包装或仓贮的人员，应穿着适合于其履行职责的清洁衣服，按需要，按头部、脸部、手部、臂部加外罩，防止药品受污染。b) 人员保持良好的个人卫生和健康。c) 未经监督人员允许，其他人不能进入限制入内的建筑物和设施。d) 任何人,在任何时间,明显表现出带有影响药品安全性和质量的疾病或开放性损伤,应避免接触各种成分、药品容器、包装设备、密封件、中间体,直至病愈或经医学鉴定认为对药品安全性及质量无危害性为止教育所有人员,报告监督人员对药品有不利影响的健康情况211.34 顾问为了对问题
25、提出意见,应聘请顾问对药品生产、加工、包装或仓贮提出建议,他们受过足够的教育,培训,且有丰富的实践经验,保留他们的姓名、地址、任何的顾问资格及服务形式等履历资料.Protective apparel 洁净服，保护服sanitation 卫生，卫生设施，jeopardize 危害5Subpart C-Buildings and Facilities 211.42 Design and construction features. （a） Any building or buildings used in the manufacture, processing, packing, or holdi
26、ng of a drug product shall be of suitable size, construction and location to facilitate cleaning, maintenance, and proper operations. （b） Any such building shall have adequate space for the orderly placement of equipment and materials to prevent mixups between different components, drug product cont
27、ainers, closures, labeling, in-process materials, or drug products, and to prevent contamination. The flow of components, drug product containers, closures, labeling, in-process materials, and drug products through the building or buildings shall be designed to prevent contamination. （c） Operations
28、shall be performed within specifically defined areas of adequate size. There shall be separate or defined areas or such other control systems for the firms operations as are necessary to prevent contamination or mixups during the course of the following procedures:(1) Receipt, identification, storag
29、e, and withholding from use of components, drug product containers, closures, and labeling, pending the appropriate sampling, testing, or examination by the quality control unit before release for manufacturing or packaging;(2) Holding rejected components, drug product containers, closures, and labe
30、ling before disposition; (3) Storage of released components, drug product containers, closures, and labeling; (4) Storage of in-process materials; (5) Manufacturing and processing operations;(6) Packaging and labeling operations;(7) Quarantine storage before release of drug products;C厂房和设施21142 设计与建
31、造特征（a） 任何用于某类药品生产、加工、包装或贮存得厂房或建筑群，大小适宜，结构与位置使其易清洁、保养、适合操作。（b） 建筑群有足够的空间来有条理地安装设备和放置材料，避免不同类的成分、药品容器、密封件、标签、中间体或药品等相互混放，防止污染。通过厂房的上述物料其流向在设计时要防止污染。（c） 操作应在明确规定的，大小适中的地区进行。这些地区按规定各自格开，以防污染。下列操作须在单独的地区内进行：(1) 发放给生产或包装前，质量控制部门取样期间，成分、药品容器、密封件及标签的签收、鉴别、贮存及拒收。(2) 在处理前，拒收的成分、药品容器、密封件及标签的贮存。(3) 已发放的成分、药品容器、
32、密封件及标签的贮存。(4) 中间体的贮存。(5) 生产与加工操作。(6) 包装和贴标签操作。(7) 药品发放前隔离贮存。6identification 辨别，证明withholding 扣交quality control （QC）质量管理，质量控制Quarantine 检疫，隔离(8) Storage of drug products after release;(9) Control and laboratory operations;(10)Aseptic processing, which includes as appropriate: I） Floors, walls, and ce
33、ilings of smooth, hard surfaces that are easily cleanable;II） Temperature and humidity controls;III） An air supply filtered through high-efficiency particulate air filters under positive pressure, regardless of whether flow is laminar or nonlaminar;IV） A system for monitoring environmental condition
34、s;V） A system for cleaning and disinfecting the room and equipment to produce aseptic conditions;VI） A system for maintaining any equipment used to control the aseptic conditions.（d） Operations relating to the manufacture, processing, and packing of penicillin shall be performed in facilities separa
35、te from those used for other drug products for human use.(8) 发放后药品的贮存。(9) 控制与实验室操作。(10)无菌操作及有关要求：I） 地板、墙壁和天花板平滑、坚硬、表面易清洁；II） 温度与湿度控制；III） 空气经高效过滤 器，在正压下过滤，层流或非层流均可；IV） 环境检测系统；V） 创造无菌环境，房间和设备的清洁、消毒系统；VI） 控制无菌环境的设备维修系统。（d） 青霉素生产、加工及包装设备与生产其他人用药品的设备分开。aseptic 无菌的，防腐剂 asepsis 无菌filter 过滤器，滤过，渗入laminar 层
36、状或薄片状的，层流disinfect 消毒 penicillin 青霉素（盘尼西林）7 211.44 Lighting.Adequate lighting shall be provided in all areas. 211.46 Ventilation, air filtration, air heating and cooling. （a） Adequate ventilation shall be provided.（b） Equipment for adequate control over air pressure, micro-organisms, dust, humidity,
37、 and temperature shall be provided when appropriate for the manufacture, processing, packing, or holding of a drug product.（c） Air filtration systems, including prefilters and particulate matter air filters, shall be used when appropriate on air supplies to production areas. If air is recirculated t
38、o production areas, measures shall be taken to control recirculation of dust from production. In areas where air contamination occurs during production, there shall be adequate exhaust systems or other systems adequate to control contaminants.（d） Air-handling systems for the manufacture, processing,
39、 and packing of penicillin shall be completely separate from those for other drug products for human use.21144 照明所有地区均须充足的照明。21146 通风、空气过滤、空气加热与冷却（a） 提供足够的通风。（b） 提供足够控制空气正压、微生物、尘土、湿度和温度的设备，适应药品生产、加工和贮存之需要。（c） 空气过滤系统，包括预过滤器和微粒物质空气过滤器。空气经过滤才送至生产区，如果空气是循环到生产区，应测量尘埃含量，控制从生产区带来的尘埃。在生产区，空气中发生空气污染，应用排气系统或其
40、他系统充分抽出空气，控制污染。（d） 青霉素生产、加工和包装的空气输送系统应与其他人用药品的空气输送系统完全分开。ventilation 通风，流通空气micro-organism 微生物 recirculate 再通行, 再流通exhaust systems 排气系统air-handling systems 空气输送系统8 211.48 Plumbing. (a) Potable water shall be supplied under continuous positive pressure in a plumbing system free of defects that could
41、contribute contamination to any drug product. Potable water shall meet the standards prescribed in the Environmental Protection Agencys Primary Drinking Water Regulations set forth in 40 CFR part 141. Water not meeting such standards shall not be permitted in the potable water system. (b) Drains sha
42、ll be of adequate size and, where connected directly to a sewer, shall be provided with an air break or other mechanical device to prevent back-siphonage. 43 FR 45077, Sept. 29, 1978, as amended at 48 FR 11426, Mar. 18, 1983 211.50 Sewage and refuse.Sewage, trash, and other refuse in and from the bu
43、ilding and immediate premises shall be disposed of in a safe and sanitary manner. 211.52 Washing and toilet facilities.Adequate washing facilities shall be provided, including hot and cold water, soap or detergent, air dryers or single-service towels, and clean toilet facilities easily accessible to
44、 working areas.21148 管件(a) 在持续正压下，应在对药品无污染管道系统内供应饮用水。饮用水应符合环境保护机构制定的“基本饮用水条例”标准（40CFR141 部分） 。不符合该标准的水不准进入水系统。(b) 排水设备应有足够的大小，可直接连接排水管及安装防止虹吸倒流的空气破坏设备或其他机械设备。43FR 45077，1978 年 9月 29 日，修正于 48FR 11426，1983 年 3 月 18日21150 污水和废料来自厂房和附近建筑物的污水、垃圾及其他废料，用安全、卫生的方法处理。21152 洗涤和洗设备提供适当的洗涤设备，包括热、冷水、肥皂、清洁剂、空气干燥器或
45、专用毛巾及易进入厕所的清洁设备。potable water 饮用水drain 排水沟，排水设备back-siphonage 虹吸倒流sewage 下水道 , 污水sanitary 卫生的，清洁的，消毒的sanitation. 环境卫生single-service towels 专用毛巾9 211.56 Sanitation.a) Any building used in the manufacture, processing, packing, or holding of a drug product shall be maintained in a clean and sanitary co
46、ndition, Any such building shall be free of infestation by rodents, birds, insects, and other vermin (other than laboratory animals). Trash and organic waste matter shall be held and disposed of in a timely and sanitary manner.b) There shall be written procedures assigning responsibility for sanitat
47、ion and describing in sufficient detail the cleaning schedules, methods, equipment, and materials to be used in cleaning the buildings and facilities; such written procedures shall be followed.c) There shall be written procedures for use of suitable raticides, insecticides, fungicides, fumigating ag
48、ents, and cleaning and sanitizing agents. Such written procedures shall be designed to prevent the contamination of equipment, components, drug product containers, closures, packaging, labeling materials, or drug products and shall be followed. Raticides, insecticides, and fungicides shall not be us
49、ed unless registered and used in accordance with the Federal Insecticide, Fungicide, and Raticide Act (7 U.S.C. 135).d) Sanitation procedures shall apply to work performed by contractors or temporary employees as well as work performed by full-time employees during the ordinary course of operations. 21156 环境卫生a) 所有用作药品生产、加工、包装及贮存的厂房应保持清洁、卫生的环境，且不受啮齿动物、鸟类、昆虫及其他害虫侵扰（实验动物除外） 。垃圾和有机废料，及时以卫生的方法控制与处理。b) 填写分配卫生清洁任务和详细的清洁项目、方法、设备，用于清洁厂房和设施的材料的一览表。c) 填写使用的杀鼠剂、杀昆虫剂、杀真菌剂、薰蒸剂、去垢剂和消毒剂一览表。防止这些物品对设备、成份、药品容器、密封件、包装材料、标签或药品污染。除依据联邦杀虫剂、杀真菌剂及
