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1、GMP 英文版精品文档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 pertai
2、n 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 with app
3、licable 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 in the
4、 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 their i
5、ntended 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 manufa
6、cturing 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。（c） 在考虑经提议的，发表
7、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，属于 explicitly 明白地，确切地s
8、upersede 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, closures, in-process materi
9、als, 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 rejecting drug products manu
10、factured, 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 to the quality contro
11、l 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 shall be in writing;
12、 such written procedures shall be followed. B组织与人员21122质量控制部门的职责（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） 本部门有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
13、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 thereof, to enable th
14、at 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 th
15、ey 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 person responsible for sup
16、ervising 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, strength, quality, and purity that it purports or is re
