21CFR Part 210&211
§ 211.173 - Laboratory animals. § 211.176 - Penicillin contamination.
Subpart J--Records and Reports § 211.180 - General requirements.
§ 211.182 - Equipment cleaning and use log. § 211.184 - Component, drug product container, closure, and labeling records.
§ 211.186 - Master production and control records.
§ 211.188 - Batch production and control records. § 211.192 - Production record review. § 211.194 - Laboratory records. § 211.196 - Distribution records. § 211.198 - Complaint files.
Subpart K--Returned and Salvaged Drug Products
§ 211.204 - Returned drug products. § 211.208 - Drug product salvaging.
§ 211.173实验动物 § 211.176青霉素污染
J. 记录和报告
§ 211.180总体要求
§ 211.182设备清洁和台帐
§ 211.184组份、药品容器、密封器及标签记录
§ 211.186主生产和控制的记录 § 211.188批生产和控制记录 § 211.192生产记录审核 § 211.194实验记录 § 211.196销售记录 § 211.198投诉档案
K. 药品的退回和再利用 § 211.204药品的退回 § 211.208药品的再利用
Page 9 of 48
21CFR Part 210&211
PART 211 CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED
PHARMACEUTICALS
Subpart A--General Provisions Sec. 211.1 Scope.
A—— 总则 211.1范围
(a) The regulations in this part contain the （a）本部分的条例包含人用或兽用药品制备的minimum current good manufacturing practice 最低限度的现行药品生产质量管理规范for preparation of drug products for （GMP） administration to humans or animals.
(b) The current good manufacturing practice （b）在21CFR里的这些针对普通药品的现行regulations in this chapter as they pertain to GMP条例和21CFR 600至680的所有部分针drug products; in parts 600 through 680 of this 对人用生物制品的现行GMP条例，在21CFRchapter, as they pertain to drugs that are also 的1271部分中，法规适用于人类细胞，组织biological products for human use; and in part 和细胞组织为底物的产品（HCT/Ps）和一些药1271 of this chapter, as they are applicable to 品，这些药品（符合《法案》505部分的关于drugs that are also human cells, tissues, and 提交申请的审核部分或是《公共健康服务法案》cellular and tissue-based products (HCT/Ps) 351部分的生物产品申请许可）除非明确另有and that are drugs (subject to review under an 说明者外，应认为是对本部分条例的补充，而application submitted under section 505 of the 不是代替。在21CFR的这部分和其他部分，act or under a biological product license 或者是在21CFR的600到680的部分，或是application under section 351 of the Public 1271部分法规有发生冲突的情况下，则可用存Health Service Act); supplement and do not 在争议药品的特定具体的法规来替代一般性supersede the regulations in this part unless 的。 the regulations explicitly provide otherwise. In the event of a conflict between applicable regulations in this part and in other parts of this chapter, or in parts 600 through 680 of this chapter, or in part 1271 of this chapter, the regulation specifically applicable to the drug product in question shall supersede the more general.
(c) Pending consideration of a proposed （c）在考虑经提议的，发表在1978年9月29exemption, published in the Federal Register of 日联邦注册表（FR）上的一个免除项是，若产September 29, 1978, the requirements in this 品及其所有成份是以人用食品形式作一般销售part shall not be enforced for OTC drug 和消费且这些产品根据其预期用途，亦可列入products if the products and all their ingredients 药品的范围内，则不应对这些非处方药（OTC）are ordinarily marketed and consumed as 实施本部分条例，直至进一步的通知为止。human foods, and which products may also fall 21CFR 110部分和113至119部分的条例用within the legal definition of drugs by virtue of 于鉴别这些OTC药品是否按照GMP的要求生their intended use. Therefore, until further 产、加工、包装和贮存。 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
Page 10 of 48
21CFR Part 210&211
foods are manufactured, processed, packed, or held under current good manufacturing practice.
Sec. 211.3 Definitions
211.3定义
The definitions set forth in 210.3 of this chapter 21CFR 210?3中解释的定义适用于本部分 apply in this part.
Subpart B--Organization and Personnel
B——组织机构和人员
Sec. 211.22 Responsibilities of quality control 211.22质量控制部门的职责 unit.
(a) There shall be a quality control unit that （a）需建立质量控制部门，本部门有批准和拒shall have the responsibility and authority to 收所有组份、药品包装容器、密封器、中间体、approve or reject all components, drug product 包装材料、标签及药品的职责与权力，审核生containers, closures, in-process materials, 产记录的权力，保证不产生差错，或若发生差packaging material, labeling, and drug 错，保证他们充分调查。本部门负责根据合同，products, and the authority to review 批准或拒收由其它公司生产、加工、包装或贮production records to assure that no errors 存的药品。 have occurred or, if errors have occurred, that
they have been fully investigated. The quality
control unit shall be responsible for approving or rejecting drug products manufactured, processed, packed, or held under contract by another company.
(b) Adequate laboratory facilities for the testing （b）质量控制部门要可以获得足够的实验室设and approval (or rejection) of components, 备用于检验和批准（或拒收）各种组份、药品drug product containers, closures, packaging 容器、密封器、包装材料及中间体。 materials, in-process materials, and drug products shall be available to the quality control unit.
(c) The quality control unit shall have the （c）本部门有批准或驳回影响药品的均一性、responsibility for approving or rejecting all 规格、质量和纯度的所有程序或质量标准的职procedures or specifications impacting on the 责。 identity, strength, quality, and purity of the drug
product.
(d) The responsibilities and procedures （d）适用于本部门的职责与程序，应成文件，
applicable to the quality control unit shall be in 并应遵循执行。 writing; such written procedures shall be followed.
Sec. 211.25 Personnel qualifications.
211.25人员资质
(a) Each person engaged in the manufacture, (a)每位从事药品生产、加工、包装或储存工作processing, packing, or holding of a drug 人员，应接受培训、教育及有实践经验，完成product shall have education, training, and 委派的各项任务。培训是按照现行GMP（包括experience, or any combination thereof, to 21-CFR 211部分中的现行GMP条例和这些条
Page 11 of 48
21CFR Part 210&211
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 these regulations) as they relate to the employee's 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.
例要求的文件）中涉及员工的职能。邀请有资质的人员指导，并连续多次培训，保证员工熟悉现行GMP对他们的要求。
(b) Each person responsible for supervising (b)负责监督药品的生产、加工、包装或储存工the manufacture, processing, packing, or 作的每一个工作人员，应受教育、培训及有经holding of a drug product shall have the 验，来完成委派的各项任务。以此作为提供药education, training, and experience, or any 品具有安全性、均一性、规格、质量及纯度的combination thereof, to perform assigned 保证。 functions in such a manner as to provide assurance that the drug product has the safety, identity, strength, quality, and purity that it purports or is represented to possess.
(c) There shall be an adequate number of （c）有足够人数的合格员工进行和监督每种药qualified personnel to perform and supervise 品的生产、加工、包装或储存。 the manufacture, processing, packing, or holding of each drug product.
Sec. 211.28 Personnel responsibilities.
211.28人员职责
(a) Personnel engaged in the manufacture, （a）从事药品生产、加工、包装或储存的人员，processing, packing, or holding of a drug 应穿着适合于其工作的清洁服装。必要时应佩product shall wear clean clothing appropriate 戴保护性用品，如头部、脸部、手部、臂部要for the duties they perform. Protective apparel, 戴上遮护用品，防止药物受污染。 such as head, face, hand, and arm coverings, shall be worn as necessary to protect drug products from contamination.
(b) Personnel shall practice good sanitation (b)人员要保持良好的个人卫生和健康习惯。 and health habits.
(c) Only personnel authorized by supervisory (c)只有经监督人员授权的人员才可以进入建筑personnel shall enter those areas of the 物和设施的限制区域。 buildings and facilities designated as limited-access areas.
(d) Any person shown at any time (either by （d）任何人，在任何时间（无论是通过医学检medical examination or supervisory 查或是监控观察），患有危及药品安全性和质量observation) to have an apparent illness or 的疾病或开放性损伤，都应避免接触各种组份、open lesions that may adversely affect the 药品容器、包装设备、密封器、中间体和最终safety or quality of drug products shall be 产品，直至健康状况已恢复或是有资格的医学
Page 12 of 48
相关推荐：
loading