suitable rodenticides, insecticides, fungicides, fumigating agents, and cleaning and sanitizing agents. Such written procedures shall be designed to prevent the contamination of equipment, components, drug product containers, closures, packaging, labeling materials, or drug products and shall be 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 performed by contractors or temporary employees as well as work performed by full-time employees during the ordinary course of operations. § 211.58 Maintenance. 熏蒸剂、去垢剂和消毒剂一览表，应有成文规定。防止这些操作对设备、成份、药品容器密封件、包装材料、标签或药品产生污染。除依据联邦杀虫剂、杀真菌剂及杀鼠剂法规（7U.S.C135）已登记和使用的品种外，其他的不能使用。 (d) 消毒程序应适用于合同雇用或临时雇员，如同全职雇员一样在普通例行的操作时执行。 211?58保养 Any building used in the manufacture, processing, packing, or holding of a drug product shall be maintained in a good state of repair. Subpart D-Equipment 任何用于药品生产、加工、包装或贮存的厂房保持良好状态。 D．设备 § 211.63 Equipment design, size, and location. Equipment used in the manufacture, processing, packing, or holding of a drug product shall be of appropriate design, adequate size, and suitably located to facilitate operations for its intended use and for its cleaning and maintenance. § 211.65 Equipment construction. (a) Equipment shall be constructed so that surfaces that contact components, in-process materials, or drug products shall not be reactive, additive, or absorptive so as to alter the safety, identity, strength, quality, or purity of 211?63设备的设计、尺寸及位置 药品生产、加工、包装或贮存设备，设计合理，大小适当，布置合理，便于操作、清洁和保养。 211?65设备构造 (a)设备表面与各种成份、中间体或药品接触，不会发生改变药品的安全性、均一性、效价或含量、质量或纯度的化学反应或吸收作用。 the drug product beyond the official or other established requirements. (b) Any substances required for operation, such as lubricants or coolants, shall not come into contact with components, drug product containers, closures, in-process materials, or drug products so as to alter the safety, identity, strength, quality, or purity of the drug product beyond the official or other established requirements. § 211.67 Equipment cleaning and maintenance. (a) Equipment and utensils shall be cleaned, maintained, and sanitized at appropriate intervals to prevent malfunctions or contamination that would alter the safety, identity, strength, quality, or purity of the drug product beyond the official or other established requirements. (b) Written procedures shall be established and followed for cleaning and maintenance of equipment, including utensils, used in the manufacture, processing, packing, or holding of a drug product. These procedures shall include, but are not necessarily limited to, the following: (1) Assignment of responsibility for cleaning and maintaining equipment; (2) Maintenance and cleaning schedules, including, where appropriate, sanitizing schedules; (3) A description in sufficient detail of the methods, equipment, and materials used in cleaning and maintenance operations, and the methods of disassembling and reassembling equipment as necessary to assure proper cleaning and maintenance; (b)操作所需的物质，如润滑剂、冷却剂等不能进入设备里，与成份、药品容器、密封件、中间体或药品接触，保证药品的安全性、均一性、效价或含量、质量或纯度不变。 211?67设备清洁与保养 (a)相隔一定时间，对设备与工具进行清洁、保养和消毒，防止出故障与污染，影响药品的安全性、均一性、效价或含量、质量或纯度。 (b)制订药品生产、加工包装或贮存设备（包括用具）的清洁和保养文字程序，并执行。这些程序包括，但不一定限于以下内容； (1)分配清洁、保养任务。 (2)保养和清洁细目一览表。 (3)详细说明用于清洁和保养时使用的方法、设备、物质。拆卸和装配设备的方法必须保证适合清洁和保养的要求。 (4) Removal or obliteration of previous batch identification; (5) Protection of clean equipment from contamination prior to use; (6) Inspection of equipment for cleanliness immediately before use. (4)除去或擦去前批遗留物的鉴定。 (5)已清除了污染的清洁设备的保护。 (6)使用前清洁设备的检查。 (7) Records shall be kept of maintenance, (7)保留保养、清洁、消毒的记录。按211?180cleaning, sanitizing, and inspection as specified 及211?182的说明检查。 in §§ 211.180 and 211.182. § 211.68 Automatic, mechanical, and electronic equipment. (a) Automatic, mechanical, or electronic equipment or other types of equipment, including computers, or related systems that will perform a function satisfactorily, may be used in the manufacture, processing, packing, and holding of a drug product. If such equipment is so used, it shall be routinely calibrated, inspected, or checked according to a written program designed to assure proper performance. Written records of those calibration checks and inspections shall be maintained. (b) Appropriate controls shall be exercised over computer or related systems to assure that changes in master production and control records or other records are instituted only by authorized personnel. Input to and output from the computer or related system of formulas or other records or data shall be checked for accuracy. The degree and frequency of input/output verification shall be based on the complexity and reliability of the computer or related system. A backup file of data entered into the computer or related system shall be maintained except where certain data, such as calculations performed in connection with laboratory analysis, are eliminated by computerization or other automated processes. 211?68自动化设备、机械化设备和电子设备 (a)用于药品生产、加工、包装和贮存的自动化、机械化或电子包括计算机或其它类型的设备。按惯例，对其设计之成文条款作标定、检查或核对，保证其工作性能良好。保留检查、标定、核对等文字记录。 (b)对保障重要生产变化的计算机或有关系统进行操作培训。操作记录或其他记录只能由被认可的人员制订。向计算机或有关系统输入或从中输出的各种方案、其他记录或资料，应核查其准确性。输入计算机或关系统内的档案资料，除与实验室共同分析计算的结果可消除外，其他的应保留。文字记录与相应的证明资料一起保存。事先设计好的硬件复制品或多台选择系统，如复印件、磁带或微型胶卷等，保证其副本资料正确、可靠及完整。出现资料改动、非人为消除或遗失时，应维修。 In such instances a written record of the program shall be maintained along with appropriate validation data. Hard copy or alternative systems, such as duplicates, tapes, or microfilm, designed to assure that backup data are exact and complete and that it is secure from alteration, inadvertent erasures, or loss shall be maintained. [43 FR 45077, Sept. 29, 1978, as amended at 60 FR 4091, Jan. 20, 1995] § 211.72 Filters. Filters for liquid filtration used in the manufacture, processing, or packing of injectable drug products intended for human use shall not release fibers into such products. Fiber-releasing filters may not be used in the manufacture, processing, or packing of these injectable drug products unless it is not possible to manufacture such drug products without the use of such filters. If use of a fiber-releasing filter is necessary, an additional non-fiber-releasing filter of 0.22 micron maximum mean porosity (0.45 micron if the manufacturing conditions so dictate) shall subsequently be used to reduce the content of particles in the injectable drug product. Use of an asbestos-containing filter, with or without subsequent use of a specific non-fiber-releasing filter, is permissible only upon submission of proof to the appropriate bureau of the Food and Drug Administration that use of a non-fiber-releasing filter will, or is likely to, compromise the safety or effectiveness of the injectable drug product. 211?72过滤器 用于生产、加工的液体过滤器或人用注射药品的包装材料不许释放出的纤维进入产品。除非不得已，不应在生产、加工中使用释放纤维的过滤器或注射药品的包装材料。若必须使用一种能释放纤维素的过滤器，最后应使用一非释放纷纷物、平均最大孔径为0.22μm(如实际生产条件限制，可用0.45μm)的附加过滤器过滤，降低注射剂内微粒量。使用含石棉的过滤器最后用或不用特殊非释放纤维过滤器均可以，但要根据FDA有关部门提供的该非释放纤维过滤器会或可能损害注射剂的安全性和有效性的证据而定。 Subpart E-Control of Components and Drug E．成份、药品容器和密封件控制 Product Containers and Closures § 211.80 General requirements. (a) There shall be written procedures describing in sufficient detail the receipt, 211?80总要求 (a)有文字详细说明成份、药品容器、密封