【正文】 te 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(chǎn)的廠房和設(shè)施的選址、設(shè)計(jì)和建造應(yīng)當(dāng)便于清潔，維護(hù)和適應(yīng)一定類(lèi)型和階段的生產(chǎn)操作。設(shè)施的設(shè)計(jì)應(yīng)盡量減少潛在的污染。如果中間體或原料藥的生產(chǎn)有微生物限度要求，那么設(shè)施設(shè)計(jì)應(yīng)相應(yīng)的限制有害微生物的污染。 Buildings and facilities should have adequate space for the orderly placement of equipment and materials to prevent mixups and contamination. 廠房和設(shè)施應(yīng)有足夠空間，以便有秩序地放置設(shè)備和物料，防止混淆和污染。 Where the equipment itself (., closed or contained system) provides adequate protection of the material, such equipment can be located outdoors. 自身能對(duì)物料提供足夠保護(hù)的設(shè)備（如關(guān)閉的或封閉的系統(tǒng)），可以在戶外放置。 The flow of materials and personnel through the building or facilities should be designed to prevent mixups and contamination. 通過(guò)廠房和設(shè)施的物流和人流的設(shè)計(jì)應(yīng)當(dāng)能防止混雜和污染。 There should be defined areas or other control systems for the following activities:● Receipt, identification, sampling, and quarantine of ining materials, pending release or rejection● Quarantine before release or rejection of intermediates and APIs● Sampling of intermediates and APIs● Holding rejected materials before further disposition (., return, reprocessing or destruction)● Storage of released materials● Production operations● Packaging and labeling operations● Laboratory operations 以下活動(dòng)應(yīng)當(dāng)有指定區(qū)域或其它控制系統(tǒng)：● 來(lái)料的接收、鑒別、取樣和待驗(yàn)，等待放行或拒收；● 中間體和原料藥放行或拒收前的待驗(yàn)；● 中間體和原料藥的取樣● 不合格物料處理（如退貨、返工或銷(xiāo)毀）前的貯存；● 已放行物料的貯存；● 生產(chǎn)操作；● 包裝及貼標(biāo)簽操作；● 實(shí)驗(yàn)室操作。 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. 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(jī)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(dá)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(shí)驗(yàn)室區(qū)域/操作通常應(yīng)當(dāng)與生產(chǎn)區(qū)隔離。有些實(shí)驗(yàn)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(duì)實(shí)驗(yàn)室測(cè)量的準(zhǔn)確性沒(méi)有負(fù)面影響，而且，實(shí)驗(yàn)室及其操作對(duì)生產(chǎn)過(guò)程，或中間體，或原料藥也沒(méi)有負(fù)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 available. 對(duì)產(chǎn)品質(zhì)量會(huì)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(rèn)合格，并進(jìn)行適當(dāng)監(jiān)控，在超出限度時(shí)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(guò)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(jì)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(xiǎn)。 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(shí)。這可以通過(guò)標(biāo)識(shí)每根管道、提供證明文件、計(jì)算機(jī)控制系統(tǒng)，或其它替代方法來(lái)達(dá)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(dá)到規(guī)定質(zhì)量由制造商進(jìn)行處理時(shí)，處理工藝應(yīng)當(dāng)經(jīng)過(guò)驗(yàn)證，并用合適的處置限度來(lái)監(jiān)測(cè)。 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(wú)菌原料藥的制造商打算或者聲稱該原料藥適用于進(jìn)一步加工生產(chǎn)無(wú)菌藥品（醫(yī)療用品）時(shí)，最終分離和精制階段的用水應(yīng)當(dāng)進(jìn)行微生物總數(shù)、致病菌和內(nèi)毒素方面的監(jiān)測(cè)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(lèi)的生產(chǎn)中，應(yīng)當(dāng)使用專(zhuān)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 pharm