【正文】 加工和貯存需要?？諝饨?jīng)過濾才送至生產(chǎn)區(qū)，如果空氣是再循環(huán)到生產(chǎn)區(qū)，應(yīng)測量塵埃含量，控制從生產(chǎn)區(qū)帶來的塵埃。（d） 青霉素生產(chǎn)、加工和包裝的空氣輸送系統(tǒng)應(yīng)與其他人用藥品的空氣輸送系統(tǒng)完全分開。飲用水應(yīng)符合環(huán)境保護(hù)機(jī)構(gòu)制訂的“基本飲用水條例”標(biāo)準(zhǔn)（40CFR141部分）。（b） 排水設(shè)備應(yīng)有足夠的大小，可直接連接排水管及安裝防止虹吸倒流的空氣破壞設(shè)備或其他機(jī)械設(shè)備。211?50污水和廢料來自水廠和附近建筑物的污水、垃圾及其他廢料，用安全、衛(wèi)生的方法處理。211?56（a） 所有用作藥品生產(chǎn)、加工、包裝及貯存的三房應(yīng)保持清潔、衛(wèi)生的環(huán)境，且不受嚙齒動物、鳥類及其他害蟲侵害擾（實驗動物除外）。（b） 填寫分配衛(wèi)生清潔任務(wù)的詳細(xì)的清潔項目、方法、設(shè)備、用于清潔廠房和設(shè)施的材料的一覽表。防止這些物品對設(shè)備、成份、藥品容器密封件、包裝材料、標(biāo)簽或藥品污染。211?58保養(yǎng)任何用于藥品生產(chǎn)、加工、包裝或貯存的廠保持良好狀態(tài)。s operations as are necessary to prevent contamination or mixups during the course of the following procedures: (1) Receipt, identification, storage, and withholding from use of ponents, drug product containers, closures, and labeling, pending the appropriate sampling, testing, or examination by the quality control unit before release for manufacturing or packaging。 (3) Storage of released ponents, drug product containers, closures, and labeling。 (5) Manufacturing and processing operations。 (7) Quarantine storage before release of drug products。 (9) Control and laboratory operations。 (ii) Temperature and humidity controls。 (iv) A system for monitoring environmental conditions。 (vi) A system for maintaining any equipment used to control the aseptic conditions. (d) Operations relating to the manufacture, processing, and packing of penicillin shall be 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. Lighting. Adequate lighting shall be provided in all areas. Sec. Ventilation, air filtration, air heating and cooling. (a) Adequate ventilation shall be provided. (b) Equipment for adequate control over air pressure, microorganisms, dust, humidity, and 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) Airhandling systems for the manufacture, processing, and packing of penicillin shall be pletely separate from those for other drug products for human use. Sec. 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 Agency39。 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(shè)備Subpart DEquipment211?63設(shè)備的設(shè)計、尺寸及位置藥品生產(chǎn)、加工、包裝或貯存設(shè)備，設(shè)計合理，大小適當(dāng)，布置合理，便于操作、清潔和保養(yǎng)。保證藥品的安全性、均一性、效價或含量、質(zhì)量或純度改變。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(shè)備清潔與保養(yǎng)（a） 相隔一定時間，對設(shè)備與工具進(jìn)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(zhì)量或純度。這些程序包括，但不一定限于以下內(nèi)容；（1） 分配清潔、保養(yǎng)任務(wù)。（3） 詳細(xì)說明用于清潔和保養(yǎng)的設(shè)備、物品和方法。（4） 除去或擦去前批遺留物的鑒定。（6） 使用前檢查清潔的設(shè)備。按211?180及211?182的說明檢查。按慣例，對其設(shè)計之成文條款作標(biāo)定、檢查或核對，保證其工作性能良好。（b） 對保障重要生產(chǎn)變化的計算機(jī)或有關(guān)系統(tǒng)進(jìn)行操作培訓(xùn)。向計算機(jī)或有關(guān)系統(tǒng)輸入或從中輸出的各種方案、其他記錄或資料，應(yīng)核查其準(zhǔn)確性。文字記錄與相應(yīng)的證明資料一起保存。出現(xiàn)資料改動、非人為消除或遺失時，應(yīng)維修。 (2) Maintenance and cleaning schedules, including, where appropriate, sanitizing schedules。 (4) Removal or obliteration of previous batch identification。 (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