【正文】 ises and equipment must be located, designed, constructed, adapted and maintained to suit the operations to be carried out. Their layout and design must aim to minimise the risk of errors and permit effective cleaning and maintenance in order to avoid crosscontamination, build up of dust or dirt and, in general, any adverse effect on the quality of products.廠房與設(shè)備的選址、設(shè)計(jì)、建造、改造及維護(hù)必須與所要實(shí)施的操作相適應(yīng)。廠房和設(shè)備的設(shè)計(jì)和布局必須能最大限度降低發(fā)生差錯(cuò)的風(fēng)險(xiǎn)，能允許有效清潔和維護(hù)，從而避免交叉污染、避免 積塵，總之，避免對(duì)產(chǎn)品質(zhì)量的任何不利影響PREMISES廠房General 總則. Premises should be situated in an environment which, when considered together with measures to protect the manufacture, presents minimal risk of causing contamination of materials or products.應(yīng)根據(jù)廠房及生產(chǎn)保護(hù)措施綜合考慮選址問題，廠房所處的環(huán)境應(yīng)能使物料或產(chǎn)品遭受污染的風(fēng)險(xiǎn)最小 。. Premises should be carefully maintained, ensuring that repair and maintenance operations do not present any hazard to the quality of products. They should be cleaned and, where applicable, disinfected according to detailed written procedures.應(yīng)當(dāng)精心維護(hù)廠房，應(yīng)當(dāng)確保維修和維護(hù)活動(dòng)不影響產(chǎn)品的質(zhì)量。應(yīng)當(dāng)按照詳細(xì)的書面規(guī)程清潔廠房，必要時(shí)消毒。. Lighting, temperature, humidity and ventilation should be appropriate and such that they do not adversely affect, directly or indirectly, either the medicinal products during their manufacture and storage, or the accurate functioning of equipment.廠房應(yīng)有適當(dāng)?shù)恼彰?、溫濕度與通風(fēng)，并確保在生產(chǎn)與貯存期間藥品質(zhì)量以及相關(guān)設(shè)備的性能不直接或間接地受其不良影響。. Premises should be designed and equipped so as to afford maximum protection against the entry of insects or other animals.廠房的設(shè)計(jì)與裝備應(yīng)能最大程度防止昆蟲或其他動(dòng)物的進(jìn)入。. Steps should be taken in order to prevent the entry of unauthorised people. Production, storage and quality control areas should not be used as a right of way by personnel who do not work in them.應(yīng)采取適當(dāng)措施，防止未經(jīng)批準(zhǔn)的人員進(jìn)入。生產(chǎn)、貯存和質(zhì)量控制區(qū)不應(yīng)作為非本區(qū)工作人員的通道。Production Area 生產(chǎn)區(qū). In order to minimise the risk of a serious medical hazard due to crosscontamination, dedicated and selfcontained facilities must be available for the production of particular medicinal products, such as highly sensitising materials (. penicillins) or biological preparations (. from live microorganisms). The production of certain additional products, such as certain antibiotics, certain hormones, certain cytotoxics, certain highly active drugs and nonmedicinal products should not be conducted in the same facilities. For those products, in exceptional cases, the principle of campaign working in the same facilities can be accepted provided that specific precautions are taken and the necessary validations are made. The manufacture of technical poisons, such as pesticides and herbicides, should not be allowed in premises used for the manufacture of medicinal products.為降低由交叉污染所致嚴(yán)重醫(yī)學(xué)危害風(fēng)險(xiǎn)，一些特殊藥品，如高致敏藥品 （如，青霉素類 ）或生物制劑 （如，活性微生物類）必須采用專用和獨(dú)立的生產(chǎn)設(shè)施。某些抗生素、激素 、細(xì)胞毒素、高活性藥物和非藥品，不應(yīng)在同一生產(chǎn)設(shè)施內(nèi)生產(chǎn)。對(duì)于這些產(chǎn)品，在特殊情況下，可以采用階段式生產(chǎn)，共用生產(chǎn)設(shè)施，但應(yīng)采取特別防護(hù)措施并經(jīng)過必要的驗(yàn)證。藥品生產(chǎn)廠房不得用于生產(chǎn)殺蟲劑和除草劑等工業(yè)毒性物品。. Premises should preferably be laid out in such a way as to allow the production to take place in areas connected in a logical order corresponding to the sequence of the operations and to the requisite cleanliness levels.廠房應(yīng)當(dāng)按生產(chǎn)工藝流程及相應(yīng)潔凈級(jí)別要求適當(dāng)布局。. The adequacy of the working and inprocess storage space should permit the orderly and logical positioning of equipment and materials so as to minimise the risk of confusion between different medicinal products or their ponents, to avoid crosscontamination and to minimise the risk of omission or wrong application of any of the manufacturing or control steps.工作區(qū)和中間物料貯存區(qū)應(yīng)有足夠的空間，使設(shè)備和物料能夠有序存放，從而使不同藥品或組分之間混淆的風(fēng)險(xiǎn)降至最低，避免交叉污染，將任何生產(chǎn)或控制步驟遺漏或出差錯(cuò)的風(fēng)險(xiǎn)降至最低。. Where starting and primary packaging materials, intermediate or bulk products are exposed to the environment, interior surfaces (walls, floors and ceilings) should be smooth, free from cracks and open joints, and should not shed particulate matter and should permit easy and effective cleaning and, if necessary, disinfection.起始物料、內(nèi)包裝材料、中間體或半成品暴露環(huán)境的內(nèi)表面（墻壁、地面、天花 板）應(yīng)當(dāng)平整光滑、無裂縫、接口嚴(yán)密、無顆粒物脫落，便于有效清潔和必要時(shí)進(jìn)行消毒。. Pipe work, light fittings, ventilation points and other services should be designed and sited to avoid the creation of recesses which are difficult to clean. As far as possible, for maintenance purposes, they should be accessible from outside the manufacturing areas.管道、照明設(shè)施、通風(fēng)口和其他公用設(shè)施的設(shè)計(jì)和安裝應(yīng)避免出現(xiàn)難以清潔的部位。應(yīng)盡可能做到在生產(chǎn)區(qū)外部對(duì)它們進(jìn)行維護(hù)。. Drains should be of adequate size, and have trapped gullies. Open channels should be avoided where possible, but if necessary, they should be shallow to facilitate cleaning and disinfection.排水設(shè)施應(yīng)大小適宜，安裝防止倒灌的裝置。應(yīng)盡可能避免明溝，不可避免時(shí)，明溝宜淺，以方便清潔和消毒。. Production areas should be effectively ventilated, with air control facilities (including temperature and, where necessary, humidity and filtration) appropriate both to the products handled, to the operations undertaken within them and to the external environment.應(yīng)根據(jù)所處理的產(chǎn)品、生產(chǎn)操作要求及外部環(huán)境狀況配置空調(diào)控制設(shè)施（包括溫度控制、必要的濕度控制和空氣凈化過濾) ，使生產(chǎn)區(qū)具有有效的通風(fēng)。. Weighing of starting materials usually should be carried out in a separate weighing room designed for that use.起始物料的稱量通常應(yīng)在專門設(shè)計(jì)的稱量室內(nèi)進(jìn)行。. In cases where dust is generated (. during sampling, weighing, mixing and processing operations, packaging of dry products), specific provisions should be taken to avoid crosscontamination and facilitate cleaning.在產(chǎn)塵區(qū)域（如，取樣、稱量、混合與加工、干燥產(chǎn)品包裝)，應(yīng)采取專門的措施避免交叉污染并便于清潔。. Premises for the packaging of medicinal products should be specifically designed and laid out so as to avoid mixups or crosscontamination.應(yīng)對(duì)藥品包裝廠房進(jìn)行專門的設(shè)計(jì)和布局，以避免混淆或交叉污染。. Productions areas should be well lit, particularly where visual online controls are carried out. 生產(chǎn)區(qū)應(yīng)有足夠的照明，特別是產(chǎn)品在線目檢區(qū)。. Inprocess controls may be carried out within the production area provided they do not carry any risk for the production.在生產(chǎn)區(qū)域內(nèi)可進(jìn)行中間過程控制，但不得給生產(chǎn)帶來風(fēng)險(xiǎn)。Storage Areas 貯存區(qū). Storage areas should be of sufficient capacity to allow orderly storage of the various categories of materials and products: starting and packaging materials, intermediate, bulk and finished products, products in quarantine, released, rejected, returned or recall