【正文】 es should be separate from, but easily accessible to, manufacturing areas. Adequate facilities for showering and/or changing clothes should be provided, when appropriate. 應(yīng)當(dāng)為員工提供足夠和清潔的盥洗設(shè)施。這些盥洗設(shè)施應(yīng)當(dāng)裝有冷熱水（視情況而定）、肥皂或洗滌劑，干手機和一次性毛巾。盥洗室應(yīng)當(dāng)與生產(chǎn)區(qū)隔離，但要便于達到。應(yīng)當(dāng)根據(jù)情況提供足夠的淋浴和/或更衣設(shè)施。 Laboratory areas/operations should normally be separated from production areas. Some laboratory areas, in particular those used for inprocess controls, can be located in production areas, provided the operations of the production process do not adversely affect the accuracy of the laboratory measurements, and the laboratory and its operations do not adversely affect the production process, intermediate, or API. 實驗室區(qū)域/操作通常應(yīng)當(dāng)與生產(chǎn)區(qū)隔離。有些實驗室區(qū)域，特別是用于中間控制的，可以位于生產(chǎn)區(qū)內(nèi)，只要生產(chǎn)工藝操作對實驗室測量的準(zhǔn)確性沒有負面影響，而且，實驗室及其操作對生產(chǎn)過程，或中間體，或原料藥也沒有負面影響。 Utilities 公用設(shè)施 All utilities that could affect product quality (., steam, gas, pressed air, heating, ventilation, and air conditioning) should be qualified and appropriately monitored and action should be taken when limits are exceeded. Drawings for these utility systems should be 對產(chǎn)品質(zhì)量會有影響的所有公用設(shè)施（如蒸汽，氣體，壓縮空氣和加熱，通風(fēng)及空調(diào)）都應(yīng)當(dāng)確認合格，并進行適當(dāng)監(jiān)控，在超出限度時應(yīng)當(dāng)采取相應(yīng)措施。應(yīng)當(dāng)有這些公用設(shè)施的系統(tǒng)圖。 Adequate ventilation, air filtration and exhaust systems should be provided, where appropriate. These systems should be designed and constructed to minimize risks of contamination and crosscontamination and should include equipment for control of air pressure, microorganisms (if appropriate), dust, humidity, and temperature, as appropriate to the stage of manufacture. Particular attention should be giving to areas where APIs are exposed to the environment. 應(yīng)當(dāng)根據(jù)情況，提供足夠的通風(fēng)、空氣過濾和排氣系統(tǒng)。這些系統(tǒng)應(yīng)當(dāng)根據(jù)相應(yīng)的生產(chǎn)階段，設(shè)計和建造成將污染和交叉污染降至最低限度，并包括控制氣壓、微生物（如果適用）、灰塵、濕度和溫度的設(shè)備。特別值得注意的是原料藥暴露的區(qū)域。 If air is recirculated to production areas, appropriate measures should be taken to control risks of contamination and crosscontamination. 如果空氣再循環(huán)到生產(chǎn)區(qū)域，應(yīng)當(dāng)采取適當(dāng)?shù)目刂莆廴竞徒徊嫖廴镜娘L(fēng)險。 Permanently installed pipework should be appropriately identified. This can be acplished by identifying individual lines, documentation, puter control system, or alternative means. Pipework should be located to avoid risks of contamination of the intermediate or ApI. 永久性安裝的管道應(yīng)當(dāng)有適宜的標(biāo)識。這可以通過標(biāo)識每根管道、提供證明文件、計算機控制系統(tǒng)，或其它替代方法來達到。管道的安裝處應(yīng)當(dāng)防止污染中間體或原料藥。 Drains should be of adequate size and should be provided with an air break or a suitable device to prevent backsiphonage, when appropriate. 排水溝應(yīng)當(dāng)有足夠的尺寸，而且應(yīng)當(dāng)根據(jù)情況裝有空斷器或適當(dāng)?shù)难b置，防止倒虹吸。 Water 水 Water used in the manufacture of APIs should be demonstrated to be suitable for its intended use. 原料藥生產(chǎn)中使用的水應(yīng)當(dāng)證明適合于其預(yù)定的用途。 Unless otherwise justified, process water should, at a minimum, meet World Health Organization (WHO) guidelines for drinking (portable) water quality.除非有其它理由，工藝用水最低限度應(yīng)當(dāng)符合世界衛(wèi)生組織（WHO）的飲用水質(zhì)量指南。 If drinking (portable) water is insufficient to ensure API quality and tighter chemical and/or microbiological water quality specifications are called for, appropriate specifications for physical/chemical attributes, total microbial counts, objectionable organisms, and/or endotoxins should be established. 如果飲用水不足以確保原料的質(zhì)量，并要求更為嚴(yán)格的化學(xué)和/或微生物水質(zhì)規(guī)格標(biāo)準(zhǔn)，應(yīng)當(dāng)指定合適的物理/化學(xué)特性、微生物總數(shù)、控制菌和/或內(nèi)毒素的規(guī)格標(biāo)準(zhǔn)。 Where water used in the process is treated by the manufacturer to achieve a defined quality, the treatment process should be validated and monitored with appropriate action limits. 在工藝用水為達到規(guī)定質(zhì)量由制造商進行處理時，處理工藝應(yīng)當(dāng)經(jīng)過驗證，并用合適的處置限度來監(jiān)測。 Where the manufacturer of a nonsterile API either intends or claims that it is suitable for use in further processing to produce a sterile drug (medicinal) product, water used in the final isolation and purification steps should be monitored and controlled for total microbial counts, objectionable organisms, and endotoxins. 當(dāng)非無菌原料藥的制造商打算或者聲稱該原料藥適用于進一步加工生產(chǎn)無菌藥品（醫(yī)療用品）時，最終分離和精制階段的用水應(yīng)當(dāng)進行微生物總數(shù)、致病菌和內(nèi)毒素方面的監(jiān)測和控制。 Containment 限制 Dedicated production areas, which can include facilities, air handling equipment and/or process equipment, should be employed in the production of highly sensitizing materials, such as penicillins or cephalosprins. 在高致敏性物質(zhì)，如青霉素或頭孢菌素類的生產(chǎn)中，應(yīng)當(dāng)使用專用的生產(chǎn)區(qū)，包括設(shè)施、空氣處理設(shè)備和/或工藝設(shè)備。 The use of dedicated production areas should also be considered when material of an infectious nature or high pharmacological activity or toxicity is involved (., certain steroids or cytotoxic anticancer agents) unless validated inactivation and/or cleaning procedures are established and maintained. 當(dāng)涉及具有感染性、高藥理活性或毒性的物料時（如，激素類或抗腫瘤類），也應(yīng)當(dāng)考慮專用的生產(chǎn)區(qū)，除非已建立并維持一套經(jīng)驗證的滅活和/或清洗程序。 Appropriate measures should be established and implemented to prevent crosscontamination from personnel and materials moving from one dedicated area to another. 應(yīng)當(dāng)建立并實施相應(yīng)的措施，防止由于在各專用區(qū)域間流動的人員和物料而造成的交叉污染。 Any production activities (including weighing, milling, or packaging) of highly toxic nonpharmaceutical materials, such as herbicides and pesticides, should not be conducted using the buildings and/or equipment being used for the production of APIs. Handling and storage of these highly toxic nonpharmaceutical materials should be separate from APIs. 劇毒的非藥用物質(zhì)，如除草劑、殺蟲劑的任何生產(chǎn)活動（包括稱重、研磨或包裝）都不應(yīng)當(dāng)使用生產(chǎn)原料藥所使用的廠房和/或設(shè)備。這類劇毒非藥用物質(zhì)的處理和儲存都應(yīng)當(dāng)與原料藥分開。 Lighting 照明 Adequate lighting should be provided in all areas to facilitate cleaning, maintenance, and proper operations. 所有區(qū)域都應(yīng)當(dāng)提供充足的照明，以便于清洗、保養(yǎng)或其它操作。 Sewage and Refuse 排污和垃圾 Sewage, refuse, and other waste (., solids, liquids, or gaseous byproducts from manufacturing) in and from buildings and the immediate surrounding area should be disposed of in a safe, timely, and sanitary manner. Containers and/or pipes for waste material should be clearly identified. 進入和流出廠房及鄰近區(qū)域的污水、垃圾和其它廢物（如生產(chǎn)中的固態(tài)、液態(tài)或氣態(tài)的副產(chǎn)物），應(yīng)當(dāng)安全、及時、衛(wèi)生的處理。廢物的容器和/或管道應(yīng)當(dāng)顯著地標(biāo)明。 Sanitation and Maintenance 衛(wèi)生和保養(yǎng) Buildings used in the manufacture of intermediates and APIs should be properly maintained and repaired and kept in a clean condition. 生產(chǎn)中間體和原料藥的廠房應(yīng)當(dāng)適當(dāng)?shù)乇ｐB(yǎng)、維修并保持清潔。 Written procedures should be established assigning responsibility for sanitation and d