发布时间 : 星期六 文章cGMP21CFR210211中英对照 - 图文更新完毕开始阅读3ac4505e02d276a201292ed3
chapter. The article contains one or more drugs 预混合料含有联邦食品、药品及化妆品法as defined in section 201(g) of the act. The 201(g)部分中定义的一种或一种以上的药manufacture of medicated premixes is subject 226部to the requirements of Part 226 of this chapter. 物。药用预混合料生产应符合21CFR 分中的要求。 (15) Quality control unit means any person or organizational element designated by the firm to be responsible for the duties relating to quality control. (16) Strength means: (I) The concentration of the drug substance (for example, weight/weight, weight/volume, or unit dose/volume basis), and/or (ii) The potency, that is, the therapeutic activity of the drug product as indicated by appropriate laboratory tests or by adequately developed and controlled clinical data (expressed, for example, in terms of units by reference to a standard). (17) Theoretical yield means the quantity that would be produced at any appropriate phase of manufacture, processing, or packing of a particular drug product, based upon the quantity of components to be used, in the absence of any loss or error in actual production (18) Actual yield means the quantity that is actually produced at any appropriate phase of manufacture, processing, or packing of a particular drug product. (19) Percentage of theoretical yield means the ratio of the actual yield (at any appropriate phase of manufacture, processing, or packing of a particular drug product) to the theoretical yield (at the same phase), stated as a percentage. (15)质量控制部门(Quality control unit) 指由企业任命负责质量控制相关责任的任何人员或组织机构。 (16) 含量或效价（Strength） 指： (Ⅰ)原料药的浓度(如：以重量/重量、重量/体积、单位剂量/体积为基础)；和/(或) (Ⅱ)活性(效价)也即由适当的实验室检测或由足够的临床数据得出的指定的药品治疗活性(如：可表达为对照于某标准的单位的术语)。 (17) 理论产量(Theoretical yield) 指在生产、加工或包装某种药品的任一适当阶段中，并且基于所使用的组分的数量在实际生产中无任何损失或错误的情况下，应能生产的数量。 (18) 实际产量(Actual yield) 指某种药品在生产、加工、包装的任一适当的阶段实际生产出的数量。 (19) 比率(Percentage of theoretical yield) 实际产量(生产、加工或包装某种药品的适当阶段)与理论产量(在相同阶段)的比率，以百分数表示。 (20) 验收标准(Acceptance criteria) (20) Acceptance criteria means the product 建立在相应的取样方法基础上的药品的质specifications and acceptance/rejection criteria, such as acceptable quality level and unacceptable quality level, with an associated sampling plan, that are necessary for making a decision to accept or reject a lot or batch (or any other convenient subgroups of manufactured units). 量检验标准和合格、不合格标准(如合格质量水平和不合格的质量水平)，是决定批准或拒收一批(或其他生产单元的小组)药品的必需因素。 (21) 代表性样品(Representative (21) Representative sample means a sample sample) that consists of a number of units that are 指一个样品按合理的标准抽取（如随机取样drawn based on rational criteria such as 法），并包含若干单位（元），以能保证样品random sampling and intended to assure that 准确描绘被取样品的物料。 the sample accurately portrays the material being sampled. (22) Gang-printed labeling means labeling （22）联合印刷的贴签（Gang-printed derived from a sheet of material on which more labeling） than one item of labeling is printed. 指从一张已经印刷了至少一个项目的材料上得到的贴签。 [43 FR 45076, Sept. 29, 1978, as amended at 51 FR 7389, Mar. 3, 1986; 58 FR 41353, Aug. 3, 1993] EFFECTIVE DATE NOTE: At 58 FR 41353, Aug. 8, 1993, 210.3 was amended by adding paragraph (b)(22) effective Aug. 3, 1994. Part 211 -CURRENT GOOD 211部分—制剂药品的CGMP MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS (21 CFR Part 211 As of April, 1996) Authority: Secs. 201, 501, 502, 505, 506, 507, 512, 701, 704 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321, 351, 352, 355, 356, 357, 360b, 371, 374). Source: 43 FR 45077, Sept. 29, 1978, unless otherwise noted. A.总 则 Subpart A--General Provisions 211?1范围 §211.1 - Scope. 211?3定义 §211.3 - Definitions. B．组织与人员 Subpart B--Organization and Personnel 211?22质量控制部门的职责 §211.22 - Responsibilities of quality control 211?25人员资格 unit. §211.25 - Personnel qualifications. 211?28人员职责 211?34顾问 §211.28 - Personnel responsibilities. §211.34 - Consultants. C．厂房和设施 Subpart C--Buildings and Facilities 211?42设计与建造特征 §211.42 - Design and construction features. 211?44照明 §211.44 - Lighting. 211?46通风、空气过滤、空气加热与冷却 §211.46 - Ventilation, air filtration, air heating 211?48管件 and cooling. 211?50污水和废料 §211.48 - Plumbing. 211?52洗涤和盥洗设备 §211.50 - Sewage and refuse. 211?56卫生 §211.52 - Washing and toilet facilities. 211?58保养 §211.56 - Sanitation. §211.58 - Maintenance. D．设备 Subpart D--Equipment 211?63设备的设计、尺寸及位置 §211.63 - Equipment design, size, and location. 211?65设备构造 §211.65 - Equipment construction. 211?67设备清洁与保养 §211.67 - Equipment cleaning and 211?68自动化设备、机械化设备和电子设备 211?72过滤器 maintenance. §211.68 - Automatic, mechanical, and electronic equipment. §211.72 - Filters. Subpart E--Control of Components and E．成分、药品容器和密封件控制 Drug Product Containers and Closures 211?80总要求 §211.80 - General requirements. 211?82未检验的成份、药品容器和密封件的§211.82 - Receipt and storage of untested 接收与贮存 components, drug product containers, and 211?84成份、药品容器和密封件的试验、批closures. 准或拒收 §211.84 - Testing and approval or rejection of 211?86获准的成份、药品容器和密封件的使components, drug product containers, and 用 closures. 211?87获准的成份、药品容器和密封件的复§211.86 - Use of approved components, drug 检 product containers, and closures. 211?89拒收的成份、药品容器和密封件 §211.87 - Retesting of approved components, 211?94药品密封容器和密封件 drug product containers, and closures. § 211.89 - Rejected components, drug product containers, and closures. § 211.94 - Drug product containers and closures. Subpart F--Production and Process Controls F .生产和加工控制 §211.100 - Written procedures; deviations. 211?100成文的规程、偏差 211?101成分的控制 §211.101 - Charge-in of components. 211?103 产量计算 §211.103 - Calculation of yield. 211?105设备鉴别 §211.105 - Equipment identification. §211.110 - Sampling and testing of in-process 211?110中间体和药品的取样与检验 211?111生产时间限制 materials and drug products. 211?113微生物污染的控制 §211.111 - Time limitations on production. §211.113 - Control of microbiological 211?115返工 contamination. §211.115 - Reprocessing. Subpart G--Packaging and Labeling Control G.包装和标签控制 §211.122 - Materials examination and usage 211?122材料的检查和使用标准 criteria. 211?125标签的发放 §211.125 - Labeling issuance. 211?130包装和贴签操作 §211.130 - Packaging and labeling operations. 211?132人用非处方药（OTC）保险包装的要§211.132 - Tamper-evident packaging 求 211?134药品检查 requirements for over-the-counter (OTC) 211?137有效期 human drug products. §211.134 - Drug product inspection. § 211.137 - Expiration dating. Subpart H--Holding and Distribution H．贮存和销售 § 211.142 - Warehousing procedures. 211?142入库程序 § 211.150 - Distribution procedures. 211?150销售程序 Subpart I--Laboratory Controls I?实验室控制 § 211.160 - General requirements. 211?160总要求 § 211.165 - Testing and release for distribution. 211?165销售前的检验与发放 211?166稳定性试验 § 211.166 - Stability testing. 211?167特别检验要求 §211.167 - Special testing requirements. 211?170留样 § 211.170 - Reserve samples.