21CFR Part 210&211
letters, numbers, or symbols, or any combination of them, from which the complete history of the manufacture, processing, packing, holding, and distribution of a batch or lot of drug product or other material can be determined.
此可确定某批药品或物料的生产、加工、包装、贮存或销售的情况。
(12) Manufacture, processing, packing, or （12）药品的生产、加工、包装或贮存 holding of a drug product includes 包括药品的包装和标签操作、检验、质量控制。 packaging and labeling operations, testing, and quality control of drug products.
(13) The term medicated feed means any （13）药用物料 Type B or Type C medicated feed as defined in 指在21CFR 558.3中定义的B型和C型药用物558.3 of this chapter. The feed contains one or 料。该物料含有联邦食品、药品及化妆品法more drugs as defined in section 201(g) of the 201(g)部分中定义的一种或一种以上的药物，act. The manufacture of medicated feeds is 药用物料的生产应符合21CFR 225部分中的要subject to the requirements of part 225 of this 求。 chapter.
(14) The term medicated premix means a （14）药用预混合料 Type A medicated article as defined in 558.3 of 指21CFR 558.3中定义的A型药用物料。该预this chapter. The article contains one or more 混合料含有联邦食品、药品及化妆品法201(g)drugs as defined in section 201(g) of the act. 部分中定义的一种或一种以上的药物。药用预The manufacture of medicated premixes is 混合料生产应符合21CFR 226部分中的要求。 subject to the requirements of part 226 of this chapter.
(15) Quality control unit means any person or （15）质量控制部门 organizational element designated by the firm 指由企业任命负责质量控制相关责任的任何人to be responsible for the duties relating to 员或组织机构。 quality control.
(16) Strength means: （16）规格 (i) The concentration of the drug substance (for (Ⅰ) 原料药的浓度(如：以重量/重量、重量/example, weight/weight, weight/volume, or unit 体积、单位剂量/体积为基础)；和/(或) dose/volume basis), and/or (Ⅱ) 活性(效价) 即根据适当的实验室检测或(ii) The potency, that is, the therapeutic activity 足够的临床研究可靠数据而得出的药品治疗活of the drug product as indicated by appropriate 性(例如可表达为相当于多少单位的标准物质)。 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 （17）理论产量 would be produced at any appropriate phase 指在生产、加工或包装某种药品的任一适当阶
Page 5 of 48
21CFR Part 210&211
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.
段中，并且基于所使用的组份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) Actual yield means the quantity that is （18）实际产量 actually produced at any appropriate phase of 指某种药品在生产、加工、包装的任一适当的manufacture, processing, or packing of a 阶段实际生产出的数量。 particular drug product.
(19) Percentage of theoretical yield means （19）理论收率（我们认为是实际收率） the ratio of the actual yield (at any appropriate 指生产、加工或包装某种药品的任一适当阶段phase of manufacture, processing, or packing 的实际产量与该阶段理论产量的比率，以百分of a particular drug product) to the theoretical 数表示。 yield (at the same phase), stated as a percentage.
(20) Acceptance criteria means the product （20）接受标准 specifications and acceptance/rejection 指与取样检验方法相联系的产品标准和接受/拒criteria, such as acceptable quality level and 绝标准，诸如可接受的质量水平及不可接受的unacceptable quality level, with an associated 质量水平，这是对一批或一整批（或其它产出sampling plan, that are necessary for making a 单元中方便表示的亚批）做出接受或拒绝的必decision to accept or reject a lot or batch (or 要依据。 any other convenient subgroups of manufactured units).
(21) Representative sample means a sample （21）代表性样品 that consists of a number of units that are 指一个样品包含若干单位按合理的标准抽取drawn based on rational criteria such as （如随机取样法），以能保证取到样品有代表random sampling and intended to assure that 性 。 the sample accurately portrays the material being sampled.
(22) Gang-printed labeling means labeling （22）联合印刷的贴签 derived from a sheet of material on which more 指从物料表所演变来的贴标，上面印刷有一个than one item of labeling is printed. 以上的条目。
[43 FR 45076, Sept. 29, 1978, as amended at 51 FR 7389, Mar. 3, 1986; 58 FR 41353, Aug. 3, 1993; 73 FR 51931, Sept. 8, 2008]
Page 6 of 48
21CFR Part 210&211
[Code of Federal Regulations]
[Revised as of April 1, 2009] [CITE: 21CFR211]
[Title 21, Volume 4]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER C--DRUGS: GENERAL
PART 211 CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS 211部分 对于成品制剂的现行GMP
Subpart A--General Provisions § 211.1 - Scope. 范围 § 211.3 - Definitions. 定义
A. 总则
§211.1 范围 §211.3 定义
B. 组织机构和人员
§211.22质量控制部门的职责 §211.25人员资质 §211.28人员职责 §211.34顾问
C. 建筑和设施
§ 211.42设计与建造特征 § 211.44照明
§ 211.46通风、空气过滤、空气加热与冷却
§ 211.48管件
§ 211.50污水和废料 § 211.52洗涤和盥洗设施 § 211.56卫生 § 211.58保养
D. 设备
§ 211.63 设备的设计、尺寸及位置 § 211.65 设备的建造
§ 211.67 设备的清洁和维护
§ 211.68 自动化、机械化和电子设备 § 211.72 过滤器
Subpart B--Organization and Personnel § 211.22 - Responsibilities of quality control unit. § 211.25 - Personnel qualifications. § 211.28 - Personnel responsibilities. § 211.34 - Consultants.
Subpart C--Buildings and Facilities
§ 211.42 - Design and construction features. § 211.44 - Lighting.
§ 211.46 - Ventilation, air filtration, air heating and cooling.
§ 211.48 - Plumbing.
§ 211.50 - Sewage and refuse.
§ 211.52 - Washing and toilet facilities. § 211.56 - Sanitation. § 211.58 - Maintenance.
Subpart D--Equipment 设备 § 211.63 - Equipment design, size, and location. § 211.65 - Equipment construction.
§ 211.67 - Equipment cleaning and maintenance. § 211.68 - Automatic, mechanical, and electronic equipment.
§ 211.72 - Filters.
Subpart E--Control of Components and Drug Product Containers and Closures § 211.80 - General requirements.
§ 211.82 - Receipt and storage of untested
E. 组份、药品容器和密封器控制 § 211.80 总体要求
§ 211.82 未检验的组份、药品容器和密封器的接收与贮存
Page 7 of 48
21CFR Part 210&211
components, drug product containers, and closures.
§ 211.84 - Testing and approval or rejection of components, drug product containers, and closures.
§ 211.86 - Use of approved components, drug product containers, and closures.
§ 211.87 - Retesting of approved components, 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 § 211.100 - Written procedures; deviations. § 211.101 - Charge-in of components. § 211.103 - Calculation of yield.
§ 211.105 - Equipment identification.
§ 211.110 - Sampling and testing of in-process materials and drug products.
§ 211.111 - Time limitations on production. § 211.113 - Control of microbiological contamination.
§ 211.115 - Reprocessing.
Subpart G--Packaging and Labeling Control § 211.122 - Materials examination and usage criteria.
§ 211.125 - Labeling issuance.
§ 211.130 - Packaging and labeling operations. § 211.132 - Tamper-evident packaging
requirements for over-the-counter (OTC) human drug products.
§ 211.134 - Drug product inspection. § 211.137 - Expiration dating.
Subpart H--Holding and Distribution § 211.142 - Warehousing procedures. § 211.150 - Distribution procedures.
Subpart I--Laboratory Controls § 211.160 - General requirements.
§ 211.165 - Testing and release for distribution. § 211.166 - Stability testing.
§ 211.167 - Special testing requirements. § 211.170 - Reserve samples.
§ 211.84 组份、药品容器和密封器的检测、批准或拒收
§ 211.86 批准后组份，药物容器和密封器的使用
§ 211.87 组份、药品容器和密封器的复检. § 211.89 拒收的组份、药品容器和密封器 § 211.94 药品容器和密封器
F. 生产和加工控制
§ 211.100 成文的规程、偏差 § 211.101 组份的进料 § 211.103产量计算 § 211.105设备标识
§ 211.110中间体和成品的取样与检验 § 211.111生产时间限制 § 211.113微生物污染的控制 § 211.115返工
G. 包装和标签控制
§ 211.122物料的检查和使用标准 § 211.125标签的发放 § 211.130包装和贴签操作
§ 211.132人用非处方药（OTC）保险包装的要求
§ 211.134药品检查 § 211.137有效期
H. 贮存和销售
§ 211.142入库程序 § 211.150 销售程序 I. 实验室控制
§ 211.160总体要求
§ 211.165销售的检验与放行 § 211.166稳定性实验 § 211.167特别检验要求 § 211.170留样
Page 8 of 48
相关推荐：
loading