美国FDACGMP英汉对照版范文.docx

1、美国FDA CGMP英汉对照版范文美国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 ch

2、apter, as they 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 impossib

3、le to comply with 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 exempt

4、ion, published 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

5、 by virtue of 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 unde

6、r current good 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

7、替本部分条例。（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 pertain 适合，属

8、于 explicitly 明白地，确切地supersede 代替，取代，延期 exemption 解除，免除，免税Subpart 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 containers, closur

9、es, 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 or rejecti

10、ng 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 available

11、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 control unit

12、 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、效价或含量、质量及纯度的

13、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 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 combination

14、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 required by the

15、se 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) Each perso

16、n 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, identity, stre

17、ngth, 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。培训是按照现行GMP（包

18、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purports 声称. 211.28 Pe

19、rsonnel 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 protect drug products

20、 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 medical examination or supe

21、rvisory 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 is corrected or dete

22、rmined 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 the manufacture, pro

23、cessing, 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 and the type of serv

24、ice 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顾问为了对问题提出意见,应聘请顾问对药品生产、加工、包装或仓

25、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Subpart C-Buildings and Facilities 211.42 Design and construction features. （a） Any building or buildings used in the manufacture, processing, packing, or holding of a drug product sha

26、ll 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 containers, closures, labeli

27、ng, 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 shall be performed withi

28、n 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, storage, and withholding from

29、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 labeling before disposition;

30、 (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设计与建造特征（a） 任何用于某类药品生产、加工、包装或贮

31、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、密封件及标签的贮存。(4) 中间体的贮存。(5)

32、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。identification 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 ceilings 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 press