【正文】 ent made of whether corrective action or any revalidation should be undertaken. Reasons for such corrective action should be documented. Agreed corrective actions should be pleted in a timely and effective manner.此類整改措施的理由應當文件化。 3. 人員 Personnel Qualifications 應當有足夠數量的員工具備從事和監(jiān)管原料藥和中間體生產的教育、培訓和/或經歷等資格。 Training should be regularly conducted by qualified individuals and should cover, at a minimum, the particular operations that the employee performs and GMP as it relates to the employee’s functions. Records of training should be maintained. Training should be periodically assessed. 應當由有資格的人員定期進行培訓，內容至少應當包括員工所從事的特定操作和與其職能有關的GMP。 Personnel Hygiene 員工的衛(wèi)生 Personnel should practice good sanitation and health habits. 員工應當養(yǎng)成良好的衛(wèi)生和健康習慣。其它保護性用品如頭、臉、手和臂等遮護用品必要時也應當佩帶，以免原料藥和中間體受到污染。 Smoking, eating, drinking, chewing and the storage of food should be restricted to certain designated areas separate from the manufacturing areas. Personnel suffering from an infectious disease or having open lesions on the exposed surface of the body should not engage in activities that could result in promising the quality of APIs. Any person shown at any time (either by medical examination or supervisory observation) to have an apparent illness or open lesions should be excluded from activities where the condition could adversely affect the quality of the APIs until the condition is corrected or qualified medical personnel determine that the person’s inclusion would not jeopardize the safety or quality of the APIs. 患傳染性疾病或身體表面有開放性創(chuàng)傷的員工不應當從事危及原料藥質量的生產活動。 Consultants 中間體或原料藥生產和控制的顧問應當有足夠的學歷，受訓和經驗，能勝任所承擔的工作。4. BUILDINGS AND FACILITIES 設計和結構 Buildings and facilities used in the manufacture of intermediates and APIs should be located, designed, and constructed to facilitate cleaning, maintenance, and operations as appropriate to the type and stage of manufacture. Facilities should also be designed to minimize potential contamination. Where microbiological specifications have been established for the intermediate or API, facilities should also be designed to limit exposure to objectionable microbiological contaminants, as appropriate. 用于中間體和原料藥生產的廠房和設施的選址、設計和建造應當便于清潔，維護和適應一定類型和階段的生產操作。如果中間體或原料藥的生產有微生物限度要求，那么設施設計應相應的限制有害微生物的污染。 Where the equipment itself (., closed or contained system) provides adequate protection of the material, such equipment can be located outdoors. The flow of materials and personnel through the building or facilities should be designed to prevent mixups and contamination. 通過廠房和設施的物流和人流的設計應當能防止混雜和污染。以下活動應當有指定區(qū)域或其它控制系統(tǒng)： Adequate and clean washing and toilet facilities should be provided for personnel. These facilities should be equipped with hot and cold water, as appropriate, soap or detergent, air dryers, or single service towels. The washing and toilet facilities should be separate from, but easily accessible to, manufacturing areas. Adequate facilities for showering and/or changing clothes should be provided, when appropriate.這些盥洗設施應當裝有冷熱水（視情況而定）、肥皂或洗滌劑，干手機和一次性毛巾。應當根據情況提供足夠的淋浴和/或更衣設施。有些實驗室區(qū)域，特別是用于中間控制的，可以位于生產區(qū)內，只要生產工藝操作對實驗室測量的準確性沒有負面影響，而且，實驗室及其操作對生產過程，或中間體，或原料藥也沒有負面影響。 公用設施 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 對產品質量會有影響的所有公用設施（如蒸汽，氣體，壓縮空氣和加熱，通風及空調）都應當確認合格，并進行適當監(jiān)控，在超出限度時應當采取相應措施。 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.這些系統(tǒng)應當根據相應的生產階段，設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、濕度和溫度的設備。 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)到生產區(qū)域，應當采取適當的控制污染和交叉污染的風險。 永久性安裝的管道應當有適宜的標識。管道的安裝處應當防止污染中間體或原料藥。 排水溝應當有足夠的尺寸，而且應當根據情況裝有空斷器或適當的裝置，防止倒虹吸。 原料藥生產中使用的水應當證明適合于其預定的用途。除非有其它理由，工藝用水最低限度應當符合世界衛(wèi)生組織（WHO）的飲用水質量指南。 如果飲用水不足以確保原料的質量，并要求更為嚴格的化學和/或微生物水質規(guī)格標準，應當指定合適的物理/化學特性、微生物總數、控制菌和/或內毒素的規(guī)格標準。 在工藝用水為達到規(guī)定質量由制造商進行處理時，處理工藝應當經過驗證，并用合適的處置限度來監(jiān)測。 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. 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），也應當考慮專用的生產區(qū)，除非已建立并維持一套經驗證的滅活和/或清洗程序。 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.這類劇毒非藥用物質的處理和儲存都應當與原料藥分開。 照明 Adequate lighting should be provided in all areas to facilitate cleaning, maintenance, and proper operations. Sewage and Refuse廢物的容器和/或管道應當顯著地標明。 Written procedures should be established assigning responsibility for sanitation and