Consultants advising on the manufacture, processing, packing, or holding of drug products shall have sufficient education, training, and experience, or any combination thereof, to advise on the subject for which they 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 为了对问题提出意见，聘请顾问。顾问应对药品生产、加工、包装或仓贮提出建议，他们受过足够的教育、培训，且有丰富的实践经验。保留他们的姓名、地址、任何的顾问资格证书及服务形式等履历资料。 C．厂房和设施 § 211.42 Design and construction fea[tures. (a) Any building or buildings used in the manufacture, processing, packing, or holding of a drug product shall be of suitable size, construction and location to facilitate cleaning, maintenance, and proper operations. (b) Any such building shall have adequate space for the orderly placement of equipment and materials to prevent mixups between different components, drug product containers, closures, labeling, in-process materials, or 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. 211?42设计与建造特征 (a)任何用于某类药品生产、加工、包装或贮存的厂房或建筑群，大小适宜，结构与位置使其易于清洁、保养、适合操作。 (b)建筑物有足够空间来有条理地安装设备和放置材料，避免不同类的成份、药品容器、密封件、标签、中间体或药品等相互混放，防止污染。通过厂房的上述物料其流向在设计时要防止污染。 (c) Operations shall be performed within (c)操作应在明确规定的、大小适中的地区specifically defined areas of adequate size. There shall be separate or defined areas for the 内进行。这些地区按规定各自分隔开，以防firm's operations to prevent contamination or 止污染。下列操作须在单独的地区内进行： mixups as follows: (1) Receipt, identification, storage, and withholding from use of components, drug product containers, closures, and labeling, pending the appropriate sampling, testing, or examination by the quality control unit before release for manufacturing or packaging; (2) Holding rejected components, drug product (1)发放给生产或包装前，质量控制部门取样期间，成份、药品容器、密封件及标签的签收、鉴别、贮存及拒收区域。 containers, closures, and labeling before disposition; (3) Storage of released components, drug product containers, closures, and labeling; (4) Storage of in-process materials; (5) Manufacturing and processing operations; (6) Packaging and labeling operations; (7) Quarantine storage before release of drug products; (8) Storage of drug products after release; (9) Control and laboratory operations; (10) Aseptic processing, which includes as appropriate: (I) Floors, walls, and ceilings of smooth, hard surfaces that are easily cleanable; (ii) Temperature and humidity controls; (2)在处理前，拒收的成份、药品容器、密封件及标签的贮存。 (3)已放行的成份、药品容器、密封件及标签的贮存。 (4)中间体的贮存。 (5)生产与加工操作。 (6)包装和贴标签操作。 (7)药品放行前的待验隔离贮存。 (8)放行后药品的贮存。 (9)控制室与实验室操作。 (10)无菌操作，包括如下适当的 （Ⅰ）地板、墙壁和天花板平滑、坚硬、表面易清洁； （Ⅱ）温度与湿度控制 (iii) An air supply filtered through high-efficiency particulate air filters under positive pressure, （Ⅲ）空气经高效过滤器、在正压下过滤、regardless of whether flow is laminar or 层流或非层流均可； nonlaminar; (iv) A system for monitoring environmental conditions; (v) A system for cleaning and disinfecting the room and equipment to produce aseptic conditions; (vi) A system for maintaining any equipment used to control the aseptic conditions. （Ⅳ）环境监测系统； （Ⅴ）创造无菌环境的房间和设备清洁、消毒系统； （Ⅵ）控制无菌环境的设备维修系统。 (d) Operations relating to the manufacture, （d）青霉素生产、加工及包装设备与生产processing, and packing of penicillin shall be 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] 211?44照明 § 211.44 Lighting. 所有地区均须提供充足的照明。 Adequate lighting shall be provided in all areas. 211?46通风、空气过滤、空气加热与冷却 § 211.46 Ventilation, air filtration, air heating and cooling. (a)提供足够的通风。 (a) Adequate ventilation shall be provided. (b)提供足够能控制空气正压、微生物、尘(b) Equipment for adequate control over air 粒、温度和湿度的设备，适应药品生产、加pressure, micro-organisms, dust, humidity, and 工和贮存需要。 temperature shall be provided when 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. (d) Air-handling systems for the manufacture, processing, and packing of penicillin shall be completely separate from those for other drug products for human use. § 211.48 Plumbing. (a) Potable water shall be supplied under continuous positive pressure in a plumbing system free of defects that could contribute contamination to any drug product. Potable water shall meet the standards prescribed in the Environmental Protection Agency's Primary Drinking Water Regulations set forth in 40 CFR part 141. Water not meeting such standards (c)空气过滤系统，包括预过滤器和微粒物质空气过滤器。空气经过滤才送至生产区，如果空气是再循环到生产区，应控制从生产区带来的尘埃。生产中发生空气污染生产区，应以排气系统或其他系统充分抽出空气，控制污染。 (d)青霉素生产、加工和包装的空气输送系统应与其他人用药品的空气输送系统完全分开。 211?48管件 (a)饮用水应在持续正压下、对药品无污染的管道系统内供。饮用水应符合环境保护机构制订的“基本饮用水条例”标准（40CFR141部分）。不符合该标准的水，不许进入水系统。 shall not be permitted in the potable water system. (b)排水设备应有足够的大小，可直接连接(b) Drains shall be of adequate size and, where 排水管及安装防止虹吸倒流的空气破坏设（43FR45077，1978年9connected directly to a sewer, shall be provided 备或其他机械设备。with an air break or other mechanical device to 月29日，修正于48FR11426，1983年3月prevent back-siphonage. 18日）。 [43 FR 45077, Sept. 29, 1978, as amended at 48 FR 11426, Mar. 18, 1983] 211?50污水和废料 来自附近建筑物的污水、垃圾及其他废料，§ 211.50 Sewage and refuse. Sewage, trash, and other refuse in and from the building and immediate premises shall be disposed of in a safe and sanitary manner. § 211.52 Washing and toilet facilities. 用安全、卫生的方法处理。 211?52洗涤和盥洗设备 提供洗涤和盥洗设备，包括热、冷水，肥皂或清洁剂，空气干燥器或专用毛巾，及干净Adequate washing facilities shall be provided, 的盥洗设备，以便于进入进行工作区。 including hot and cold water, soap or detergent, air driers or single-service towels, and clean toilet facilities easily accessible to working areas. § 211.56 Sanitation. (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. (b) There shall be written procedures assigning responsibility for sanitation and describing in sufficient detail the cleaning schedules, methods, equipment, and materials to be used in cleaning the buildings and facilities; such written procedures shall be followed. 211?56 卫生 (a)所有用作药品生产、加工、包装及贮存的厂房应保持清洁、卫生的环境，且不受啮齿动物、鸟类及其他害虫侵害扰（实验动物除外）。垃圾和有机废料，定时以卫生的方法控制处理。 (b)分配卫生清洁任务的详细的清洁项目、方法、设备、用于清洁厂房和设施的材料的一览表,应有成文规定。 (c) There shall be written procedures for use of (c)适用的杀鼠剂、杀昆虫剂、杀真菌剂、