【正文】 的環(huán)境中進行。如果取樣在倉庫以外的地區(qū)進行，應該避免可能的微生物污染和交叉污染。 There should be areas for sample collection of raw materials, when applicable. If sampling is to be made in the storage area, it should be performed in specific environment for this finality with sample collection equipments that don39。t promise the sample quality or the sampled product (.: sampling of tank truck, solvent tank). When it39。s away from the storage area, sampling should be performed in such a way that it can39。t be possible microbiological contamination and/or crosscontamination. 退回的、拒收的或召回的物料或產品應該存放在單獨的標識好的區(qū)域。Storage of returned, rejected or recalled materials or products should be performed in a segregated and identified area.. 危險性很高的物品應該存放在安全受保護的區(qū)域，并按照相關的規(guī)定及時隔離和標識。Highly active materials, substances that present risks of dependency, fire or explosion and other hazardous substances should be stored in secured and protected areas, duly segregated and identified according to the actual specific legislation.. 與GMP相關的印刷品的存儲應該安全操作，限制外人進入，避免混淆和錯誤；應該由指定的人員按照明確的書面程序搬運。Storage of printed materials related to GMP should be securely performed, with restrict access, avoiding mixings and deviations。 it should be handled for assigned personnel, following defined and written procedures.. 稱重房間Weighting Room. 原材料稱重房間或區(qū)域應該位于倉庫或生產區(qū)。房間的設計應該專門針對此用途，具有獨立的和充分的排風系統(tǒng)，防止交叉污染的產生。Rooms or areas destined to weight raw materials can be located either in the storeroom or production area. The rooms should be designed exclusively for this purpose, having independent and adequate exhaustion system, when applicable, that avoids occurrence of crosscontamination.. 生產區(qū)Production Area. 為最大限度減少交叉污染，應該有單獨的設施生產某些中間品和藥物活性成分，如生物制劑等。應該有單獨專門的區(qū)域生產高敏感性的物質。To minimize the likelihood of crosscontamination occurrence, there should be separate facilities for production of certain intermediates and active pharmaceutical inputs, such as biological preparations (live microorganisms), hormones, cytotoxic substances, immunosupressors. There should be separate and exclusive areas for the production of highly sensitizing substances (penicillin, cephalosporin and its respective derivates). Facilities should have airflow systems entirely independent, designed specifically for this purpose.. 物質設施的布局應該符合生產流程，使生產與生產操作的順序和要求的潔凈級別相適應。 Physical facilities should be arranged, according to the operational flow, in such a way to allow that the production corresponds to the sequence of production operations and to the required cleaning levels.. 生產區(qū)應該使設備和物料的布局最大程度減少不同的中間品和藥物活性成分混合的風險，避免交叉污染的產生，減少因為遺漏、疏忽或錯誤的生產和控制操作引起的風險。Production areas should allow logical and arranged positioning of equipments and materials, in such a way to minimize the mixing risk between different intermediates and active pharmaceutical inputs or its pounds, and to avoid the occurrence of crosscontamination and decrease the risk of omission, negligence or erroneous application of any step of manufacturing or control.. 對管道、照明、通風點和其他裝置的設計和安裝應該便于清潔。Piping, luminaries, ventilation points and other installations should be designed and installed in such a way to make the cleaning easy. 管道應該尺寸得當，設計能夠避免液體和氣體的回流，在不影響安全的情況下保持關閉。Graters and gutters should have adequate size and should be designed in such a way to avoid liquid or gas reflux, and should be kept closed when not interfering in the security.. 生產區(qū)應該有有效的通風系統(tǒng)，并且配備空氣控制裝置，必要時應該由合理的濕度和過濾系統(tǒng)。這些區(qū)域應該在生產期間和空閑時間定期監(jiān)控，確保滿足規(guī)定的區(qū)域要求。production areas, when applicable, should have effective ventilation system, with air control units, including temperature control and, when necessary, proper moisture and filtration system for the handled products. These areas should be regularly monitored during the production period and at rest, in order to assure the fulfillment of specifications for the area.. 中間品和藥物活性成分的包裝設備在設計上要避免產生混合或交叉污染的情況。the physical facilities for packaging intermediates and active pharmaceutical inputs should be designed to avoid the occurrence of mixings or crosscontaminations.. 根據每種操作的需要對生產區(qū)照明，特別是對于使用肉眼在線控制的區(qū)域。The production areas should be illuminated, according to the necessity of each operation, especially in locations where visual control in the production line is conducted.. 質量控制區(qū)Quality Control Area. 質量控制試驗室的設計應該便于實驗活動。有足夠的空間避免產生混合或交叉污染。Quality Control laboratories should be designed to facilitate operations performed there. They should have sufficient space in order to avoid the occurrence of mixings and crosscontamination.. 實驗室的設計應考慮使用合適的建筑材料，并有一套設備保證檢驗的環(huán)境條件和人員的健康。The laboratory should be designed considering the utilization of adequate construction materials and should have a set of devices that assure environmental conditions for the performance of analyses and the protection of personnel health.. 必要時應備有單獨的房間保護某些儀器免受電子干擾、震動，防止與濕氣和其他外部因素過分接觸。 If necessary, there should be separate rooms for protecting certain instruments from electrical interferences, vibrations, excessive contact with moisture and other external factors.. 輔助區(qū)Ancillary Areas. 休息室和餐廳應跟其他區(qū)分開。Resting rooms and refectory should be separated from other areas.. 衣服存放間、衣帽間和廁所應便于進入，供使用的人數合理。廁所設施不得與生產和倉庫直接連通。并且一直保持清潔和消毒。 Clothing rooms, cloakrooms and toilet facilities should be easily accessed and proper for the number of users. The toilet facilities should not have direct munication with the production and storage areas. They should always be clean and sanitized.. 維修區(qū)應該設在生產區(qū)、質量控制區(qū)和其他地區(qū)以外的地方。需要在生產區(qū)存放和更換的零部件應放在指定的地方并且標識好。The maintenance areas should be situated in separate locations of the production areas, Quality Control and other areas. If tools and replacement pieces are kept in production areas, they should be in reserved locations and perfectly identified for this purpose.. 公共設施Utilities. 影響產品質量的所有公共設施（蒸汽、壓縮空氣、熱空氣、通風和空調）應該進行標識、確認和合理監(jiān)控。在超出規(guī)定范圍的情況下采取糾正措施。All utilities that interfere with the product quality (steam, gases, pressed and heated air, ventilation and air conditioned) should be identified