【正文】 Sewage, trash, and other refuse in and from the building and immediate premises shall be disposed of in a safe and sanitary manner. Sec. Washing and toilet facilities. Adequate washing facilities shall be provided, including hot and cold water, soap or detergent, air driers or singleservice towels, and clean toilet facilities easily accesible to working areas. Sec. 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. (c) There shall be written procedures for use of suitable rodenticides, insecticides, fungicides, fumigating agents, and cleaning and sanitizing agents. Such written procedures shall be designed to prevent the contamination of equipment, ponents, 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 . 135). (d) Sanitation procedures shall apply to work performed by contractors or temporary employees as well as work performed by fulltime employees during the ordinary course of operations. Sec. Maintenance. Any building used in the manufacture, processing, packing, or holding of a drug product shall be maintained in a good state of repair. D．設備Subpart DEquipment211?63設備的設計、尺寸及位置藥品生產、加工、包裝或貯存設備，設計合理，大小適當，布置合理，便于操作、清潔和保養(yǎng)。Sec. 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設備制造（a） 設備表面與各種成人中間體或藥品接觸，不產生化學反應和作用。保證藥品的安全性、均一性、效價或含量、質量或純度改變。（b） 操作所需之物質，如滂沱劑、冷卻劑等不能進入設備里，與成人藥品容器、封口物品、中間體或藥品接觸，保證藥品的安全性、均一性、效價或含量、質量或純度不變。Sec. Equipment construction. (a) Equipment shall be constructed so that surfaces that contact ponents, inprocess materials, or drug products shall not be reactive, additive, or absorptive so as to alter the safety, identity, strength, quality, or purity of the drug product beyond the official or other established requirements. (b) Any substances required for operation, such as lubricants or coolants, shall not e into contact with ponents, drug product containers, closures, inprocess 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設備清潔與保養(yǎng)（a） 相隔一定時間，對設備與工具進行清潔、保養(yǎng)和消毒，防止出故障與污染，影響藥品的安全性、均一性、效價或含量、質量或純度。（b） 制訂藥品生產、加工包裝或貯存設備（包括用具）的清潔和保養(yǎng)文字程序，并執(zhí)行。這些程序包括，但不一定限于以下內容；（1） 分配清潔、保養(yǎng)任務。（2） 保養(yǎng)和清潔細目一覽表。（3） 詳細說明用于清潔和保養(yǎng)的設備、物品和方法。拆卸和裝配設備的方法必須保證適合清潔和保養(yǎng)的要求。（4） 除去或擦去前批遺留物的鑒定。（5） 已清除了污染的清潔設備的保護。（6） 使用前檢查清潔的設備。（7） 保留保養(yǎng)、清潔、消毒的記錄。按211?180及211?182的說明檢查。211?68自動化設備、機械化設備和電子設備（a） 用于藥品生產、加工、包裝和貯存的自動化、機械化或電子包括計算機或其它類型的設備。按慣例，對其設計之成文條款作標定、檢查或核對，保證其工作性能良好。保留檢查、標定、核對等文字記錄。（b） 對保障重要生產變化的計算機或有關系統進行操作培訓。操作記錄或其他記錄只能由被認可的人員制訂。向計算機或有關系統輸入或從中輸出的各種方案、其他記錄或資料，應核查其準確性。輸入計算機或關系統內的檔案資料，除與實驗室共同分析計算的結果可消除外，其他的應保留。文字記錄與相應的證明資料一起保存。事先設計好的硬件復制品或多各選擇系統，臺復印件、磁帶或微型膠卷等，保證其支持資料正確、可靠及完整。出現資料改動、非人為消除或遺失時，應維修。Sec. 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。 (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. (c) Records shall be kept of maintenance, cleaning, sanitizing, and inspection as specified in and . Sec. Automatic, mechanical, and electronic equipment. (a) Automatic, mechanical, or electronic equipment or other types of equipment, including puters, 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 puter 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 puter or related system of formulas or other records or data shall be checked for accuracy. The degree and