【正文】 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。. 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)。. 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。. 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)。. 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。. 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。. 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。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。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)。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。. 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。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。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 。. Any specific requirements for the manufacture of special groups of products, for example sterile preparations, are covered in the Supplementary Guidelines.不同類別產(chǎn)品的具體生產(chǎn)要求參見附錄，如無菌制劑。s hands and the exposed product as well as with any part of the equipment that es into contact with the products.操作人員應(yīng)當(dāng)避免裸手直接接觸藥品以及與藥品直接接觸的設(shè)備表面?？傊?，杜絕在生產(chǎn)區(qū)內(nèi)或其他可能對(duì)藥品質(zhì)量造成不良影響的區(qū)域內(nèi)的 任何不衛(wèi)生行為 。. Every person entering the manufacturing areas should wear protective garments appropriate to the operations to be carried out.進(jìn)入生產(chǎn)區(qū)的所有人員應(yīng)當(dāng)穿著與其操作相適應(yīng)的防護(hù)服。初次體檢后，在員工的工作或健康狀況需要時(shí)，應(yīng)重新進(jìn)行體檢。s knowledge. After the first medical examination, examinations should be carried out when necessary for the work and personal health.所有員工在入職前應(yīng)當(dāng)接受體檢。. All personnel should receive medical examination upon recruitment. It must be the manufacturer39。在生產(chǎn)區(qū)和控制區(qū)工作的所有員工應(yīng)當(dāng)理解并嚴(yán)格遵守這些規(guī)程。PERSONNEL HYGIENE 個(gè)人衛(wèi)生. Detailed hygiene programmes should be established and adapted to the different needs within the factory. They should include procedures relating to the health, hygiene practices and clothing of personnel. These procedures should be understood and followed in a very strict way by every person whose duties take him into the production and control areas. Hygiene programmes should be promoted by management and widely discussed during training sessions.應(yīng)制定詳細(xì)的衛(wèi)生規(guī)程并適應(yīng)工廠內(nèi)各種需要。應(yīng)當(dāng)對(duì)他們進(jìn)行密切監(jiān)督。. Visitors or untrained personnel should, preferably, not be taken into the production and Quality Control areas. If this is unavoidable, they should be given information in advance, particularly about personal hygiene and the prescribed protective clothing. They should be closely supervised.應(yīng)當(dāng)最好不把參觀者或未經(jīng)培訓(xùn)的人員帶到生產(chǎn)區(qū)或質(zhì)量控制區(qū)。應(yīng)當(dāng)保存培訓(xùn)記錄。也應(yīng)當(dāng)接受繼續(xù)培訓(xùn)，并且應(yīng)當(dāng)定期評(píng)估培訓(xùn)的實(shí)際效果。 the inspection, investigation, and taking of samples, in order to monitor factors which may affect product quality. 檢查 、調(diào)查和取樣，從而對(duì)藥品質(zhì)量影響因素進(jìn)行監(jiān)控；TRAINING 培訓(xùn). The manufacturer should provide training for all the personnel whose duties take them into production areas or into control laboratories (including the technical, maintenance and cleaning personnel), and for other personnel whose activities could affect the quality of the product.生產(chǎn)企業(yè)應(yīng)對(duì)所有因工作需要進(jìn)入生產(chǎn)區(qū)、貯 存 區(qū) 或 質(zhì) 量 控 制 實(shí) 驗(yàn) 室 的 人 員 （包括技術(shù)、維護(hù)和清潔人員），以及其活動(dòng)可能影響產(chǎn)品質(zhì)量的其他人員進(jìn)行培訓(xùn)。 the monitoring of pliance with the requirements of GMP。 the retention of records。 the designation and monitoring of storage conditions for materials and products。 批準(zhǔn)和監(jiān)管受托生產(chǎn)企業(yè)216。 216。 the approval and monitoring of suppliers of materials。培訓(xùn)216。 216。 process validation。車 間 衛(wèi) 生 ；216。 216。 the monitoring and control of the manufacturing environment。批準(zhǔn)書面程序和其他文件，其 中 包 括 修 訂 文 件 ；216。. The heads of Production and Quality Control generally have some shared, or jointly exercised, responsibilities relating to quality. These may include, subject to any national regulations:生產(chǎn)負(fù)責(zé)人和質(zhì)量負(fù)責(zé)人通常共同承擔(dān)或共同履行質(zhì)量相關(guān)的職責(zé)，基于各國(guó)的規(guī)定不同，這些職責(zé)可能包括 ：216。確保實(shí)施了適 當(dāng)?shù)?驗(yàn)證；viii. to ensure that the required initial and continuing training of his department personnel is carried out and adapted according to need. 確保對(duì)本部門人員進(jìn)行了必要的入職培訓(xùn)與持續(xù)培訓(xùn)，培訓(xùn)應(yīng)符合實(shí)際需要。批準(zhǔn)和監(jiān)督所有的受托檢驗(yàn)方；vi. to check the maintenance of his department, premises and equipment。確保進(jìn)行了所有必要的檢驗(yàn)，iv. to approve specifications, sampling instructions, test methods and other Quality Control procedures。決定批準(zhǔn)或拒絕起始物料、包裝材料、中間體、半成品與成品 ；ii. to evaluate batch records。確保實(shí)施了適當(dāng)?shù)尿?yàn)證vi. to ensure that the required initial and con