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1、1美国美国 FDA CGMP 英汉对照版英汉对照版 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, a
2、s 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 impossible to co
3、mply 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 exemption, publ
4、ished 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 virtu
5、e 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 under current
6、 good manufacturing practice. 211.3 Definitions. The definitions set forth in 210.3 of this chapter apply in this part.A总则总则 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
7、可 适用的条例，前部分的 条例可以代替本部分条 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
8、 ) 良好的生产管理规范 over-the-counter （OTC） 人用非处方药pertain 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
9、 reject all components, drug product containers, 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 con
10、trol 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 and approval (or rejection) of components, drug product containers, closures, packaging materials, in-pr
11、ocess materials, and drug products shall be 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 a
12、nd procedures applicable to the quality control unit shall be in writing; such written procedures shall be followed.B 组织与人员组织与人员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
13、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 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 o
14、f a drug product shall have education, training, and experience, or any 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 manuf
15、acturing practice regulations in this chapter and written procedures required 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 tha
16、t employees remain familiar with CGMP requirements applicable to them.(b) 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
