21CFR Part 210&211
excluded from direct contact with components, drug product containers, closures, in-process materials, and drug products until the condition is corrected or determined by competent medical personnel not to jeopardize the safety or quality of drug products. All personnel shall be instructed to report to supervisory personnel any health conditions that may have an adverse effect on drug products. Sec. 211.34 Consultants.
人员确认该员工不会对药品安全性和质量有危害。所有的人员都要被告知如果发生任何可能对药品产生不良影响的健康状况，都要向相关的监管人员报告。
211.34 顾问
Consultants advising on the manufacture, 顾问应对药品生产、加工、包装或储存提出建processing, packing, or holding of drug 议，他们要受过足够的教育、培训，且有丰富products shall have sufficient education, 的实践经验，来对他们在行的领域问题提出建training, and experience, or any combination 议。顾问的姓名、地址、资格证明及所提供服thereof, to advise on the subject for which they 务形式等资料要保存。 are retained. Records shall be maintained stating the name, address, and qualifications of any consultants and the type of service they provide.
Subpart C--Buildings and Facilities
C——建筑和设施
Sec. 211.42 Design and construction features. 211.42设计与建造特征
(a) Any building or buildings used in the (a)任何用于某类药品生产、加工、包装或储存manufacture, processing, packing, or holding 的厂房或建筑群，大小要适宜，结构与选址要of a drug product shall be of suitable size, 使其易于清洁、保养、适合操作。 construction and location to facilitate cleaning, maintenance, and proper operations.
(b) Any such building shall have adequate (b)建筑物有足够空间来有条理地摆放设备和物space for the orderly placement of equipment 料，避免不同类的组份、药品容器、密封器、and materials to prevent mixups between 标签、中间体或药品等相互混放，防止污染。different components, drug product containers, 通过厂房的上述物料其流向在设计时要防止污closures, labeling, in-process materials, or 染。 drug products, and to prevent contamination.
The flow of components, drug product
containers, closures, labeling, in-process materials, and drug products through the building or buildings shall be designed to prevent contamination.
(c) Operations shall be performed within (c)操作应在明确规定的、大小适中的区域内进specifically defined areas of adequate size. 行。在下列操作过程中，操作要分开，在特定There shall be separate or defined areas or 的区域或其他控制系统中进行，这个对于防止such other control systems for the firm's 污染或是混淆是必要的。 operations as are necessary to prevent
contamination or mixups during the course of
the following procedures:
(1) Receipt, identification, storage, and (1)放行给生产或包装前，由质量控制部门取样、withholding from use of components, drug 检测和检查期间，药品的组份、容器、密封器
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21CFR Part 210&211
product containers, closures, and labeling, pending the appropriate sampling, testing, or examination by the quality control unit before release for manufacturing or packaging;
及标签，监督接收、鉴别、储存及拒收过程：
(2) Holding rejected components, drug product (2)拒收组份、药品容器、密封器及标签处理前containers, closures, and labeling before 的储存过程； disposition;
(3) Storage of released components, drug (3)已放行的组份、药品容器、密封器及标签的product containers, closures, and labeling; 储存； (4) Storage of in-process materials; (6) Packaging and labeling operations;
(4)中间体的储存； (6)包装和贴标签操作；
(5) Manufacturing and processing operations; (5)生产与加工操作；
(7) Quarantine storage before release of drug (7)药品放行前的待验隔离储存； products;
(8) Storage of drug products after release; (9) Control and laboratory operations;
(8)放行后药品的储存； (9)控制与实验室的操作；
(10) Aseptic processing, which includes as (10)无菌操作过程，包括如下适宜的操作； appropriate:
(i) Floors, walls, and ceilings of smooth, hard (i)地板、墙壁和天花板平滑、坚硬、表面易清surfaces that are easily cleanable; 洁； (ii) Temperature and humidity controls;
(ii)温度与湿度控制；
(iii) An air supply filtered through (iii)不管是层流或非层流，空气在正压下经高效high-efficiency particulate air filters under 过滤器过滤； positive pressure, regardless of whether flow is laminar or nonlaminar ;
(iv) A system for monitoring environmental (iv)环境监测系统； conditions;
(v) A system for cleaning and disinfecting the (v)用来创造无菌条件的房间和设备清洁、消毒room and equipment to produce aseptic 的系统； conditions;
(vi) A system for maintaining any equipment (vi)用来控制无菌环境的设备维修的系统； used to control the aseptic conditions.
(d) Operations relating to the manufacture, (d)青霉素生产、加工及包装的操作所用设备与processing, and packing of penicillin shall be 生产其他人用药品的设备分开； performed in facilities separate from those used for other drug products for human use. [43 FR 45077, Sept. 29, 1978, as amended at 60 FR 4091, Jan. 20, 1995] Sec. 211.44 Lighting
211.44照明.
Adequate lighting shall be provided in all 所有区域均须提供充足的照明 areas.
Sec. 211.46 Ventilation, air filtration, air 211.46通风、空气过滤、空气加热及冷却 heating and cooling.
(a) Adequate ventilation shall be provided.
(a)应提供足够的通风
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21CFR Part 210&211
(b) Equipment for adequate control over air (b)提供足以控制空气压力、微生物、灰尘、温pressure, micro-organisms, dust, humidity, and 度和湿度的设备，来适应药品生产、加工、包temperature shall be provided when 装和储存需要。 appropriate for the manufacture, processing, packing, or holding of a drug product. (c) Air filtration systems, including prefilters and particulate matter air filters, shall be used when appropriate on air supplies to production areas. If air is recirculated to production areas, measures shall be taken to control recirculation of dust from production. In areas where air contamination occurs during production, there shall be adequate exhaust systems or other systems adequate to control contaminants.
(c)适当的时候，应对输送至生产区域的空气使用空气过滤系统，该系统包括预过滤器和微粒物质空气过滤器。如果空气再循环到生产区，应采取措施控制来自生产的灰尘循环。在生产过程中有空气污染的区域，应该有充足的排风系统或其他系统来控制污染。
(d) Air-handling systems for the manufacture, (d)青霉素生产、加工和包装的空调系统应与其processing, and packing of penicillin shall be 他人用药品的空调系统完全分开。 completely separate from those for other drug products for human use. Sec. 211.48 Plumbing.
211.48管件
(a) Potable water shall be supplied under (a)饮用水应在持续正压，对药品无污染的管道continuous positive pressure in a plumbing 系统内供应，这个管道系统内应没有可能导致system free of defects that could contribute 药品污染的缺陷。饮用水应符合环境保护机构contamination to any drug product. Potable 制订的“基本饮用水条例”标准（40CFR141部water shall meet the standards prescribed in 分）。不符合该标准的水，不许进入饮用水系统。 the Environmental Protection Agency's Primary Drinking Water Regulations set forth in 40 CFR part 141. Water not meeting such standards shall not be permitted in the potable water system.
(b) Drains shall be of adequate size and, where (b) 排水设备应有足够的大小， 在直接连接至connected directly to a sewer, shall be 下水道的地方应该提供空断或其他机械设备以provided with an air break or other mechanical 防止发生倒虹吸。 device to prevent back-siphonage.
[43 FR 45077, Sept. 29, 1978, as amended at 48 FR 11426, Mar. 18, 1983] Sec. 211.50 Sewage and refuse.
211.50污水和废料
Sewage, trash, and other refuse in and from 进入和流出建筑物和附近区域的污水、垃圾及the building and immediate premises shall be 其他废物应用安全、卫生的方法处理。 disposed of in a safe and sanitary manner. Sec. 211.52 Washing and toilet facilities
211.52洗涤和盥洗设备
Adequate washing facilities shall be provided, 提供足够的洗涤和盥洗设备，包括冷热水、肥including hot and cold water, soap or 皂或清洁剂、空气干燥器或是专用毛巾和干净detergent, air driers or single-service towels, 的盥洗设备，以便进入工作区域。 and clean toilet facilities easily accesible to working areas. Sec. 211.56 Sanitation.
211.56卫生
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21CFR Part 210&211
(a) Any building used in the manufacture, processing, packing, or holding of a drug product shall be maintained in a clean and sanitary condition, Any such building shall be free of infestation by rodents, birds, insects, and other vermin (other than laboratory animals). Trash and organic waste matter shall be held and disposed of in a timely and sanitary manner.
(a)用于药品生产、加工、包装及储存的建筑应保持清洁、卫生的环境，这种建筑不能有啮齿动物、鸟类、昆虫及其他害虫侵害（实验动物除外）。垃圾和有机废料要及时采用对环境无危害的方法处理。
(b) There shall be written procedures assigning (b)制定并执行程序来分配清洁职责，详细描述responsibility for sanitation and describing in 清洁计划、方法、设备、清洁厂房和设施的材sufficient detail the cleaning schedules, 料。 methods, equipment, and materials to be used in cleaning the buildings and facilities; such written procedures shall be followed.
(c) There shall be written procedures for use of (c)制定并执行程序来规定适用的灭鼠剂、杀虫suitable rodenticides, insecticides, fungicides, 剂、杀真菌剂、熏蒸剂、去垢剂和消毒剂应用fumigating agents, and cleaning and sanitizing 的操作过程。本程序设计是防止这些物品对设agents. Such written procedures shall be 备、组份、药品容器、密封器、包装材料、标designed to prevent the contamination of 签或药品产生污染。除依据联邦灭鼠剂、杀虫equipment, components, drug product 剂、杀真菌剂法规（7U.S.C135）已登记和使containers, closures, packaging, labeling 用的品种外，其他的杀虫剂、杀真菌剂及杀鼠materials, or drug products and shall be 剂不能使用。 followed. Rodenticides, insecticides, and fungicides shall not be used unless registered and used in accordance with the Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 135).
(d) Sanitation procedures shall apply to work (d)卫生程序要在合同工和临时工的工作中执performed by contractors or temporary 行，同时也要在全职工作人员日常操作中执行。 employees as well as work performed by full-time employees during the ordinary course of operations.
Sec. 211.58 Maintenance.
211.58保养
Any building used in the manufacture, 任何用于药品生产、加工、包装或储存的建筑processing, packing, or holding of a drug 应处于一种保持良好的保养状态。 product shall be maintained in a good state of repair. Subpart D--Equipment
D--设备
Sec. 211.63 Equipment design, size, and 211.63设备的设计、尺寸及位置 location.
Equipment used in the manufacture, 药品生产、加工、包装或储存中使用的设备，processing, packing, or holding of a drug 应设计合理，大小适当，布置合理，便于操作、product shall be of appropriate design, 清洁和保养。 adequate size, and suitably located to facilitate operations for its intended use and for its
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