【正文】 企業(yè)必須具有組織機(jī)構(gòu)圖，針對各崗位員工應(yīng)制定崗位職責(zé)說明書，對崗位職責(zé)進(jìn)行書面描述并給員工充分的授權(quán)來履行職責(zé)。確保產(chǎn)品按照造當(dāng)?shù)奈募?guī)定生產(chǎn)和貯存，從而達(dá)到質(zhì)量要求 ；ii. to approve the instructions relating to production operations and to ensure their strict implementation。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。批準(zhǔn)書面程序和其他文件，其 中 包 括 修 訂 文 件 ；216。 process validation。 216。 the monitoring of pliance with the requirements of GMP。. 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)。. All personnel should receive medical examination upon recruitment. It must be the manufacturer39?？傊?，杜絕在生產(chǎn)區(qū)內(nèi)或其他可能對藥品質(zhì)量造成不良影響的區(qū)域內(nèi)的 任何不衛(wèi)生行為 。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。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。. 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)。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。. 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。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)。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 。. 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。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。應(yīng)當(dāng)保存培訓(xùn)記錄。 the retention of records。 the approval and monitoring of suppliers of materials。車 間 衛(wèi) 生 ；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)，基于各國的規(guī)定不同，這些職責(zé)可能包括 ：216。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。構(gòu)龐大的組織中， 。GENERAL總則. The manufacturer should have an adequate number of personnel with the necessary qualifications and practical experience. The responsibilities placed on any one individual should not be so extensive as to present any risk to quality.生產(chǎn)企業(yè)應(yīng)當(dāng)配備足夠數(shù)量并具有適當(dāng)資質(zhì)及實(shí)際經(jīng)驗(yàn)的人員。 The quality risk management system should ensure that: 質(zhì)量風(fēng)險(xiǎn) 管理的原 則是 ： the evaluation of the risk to quality is based on scientific knowledge, experience with the process and ultimately links to the protection of the patient。xii. A review of any contractual arrangements as defined in Chapter 7 to ensure that they are up to date.回顧第7 章規(guī)定的所有合同、協(xié) 議 ，以確保未過時(shí)。iv. A review of all significant deviations or nonconformances, their related investigations, and the effectiveness of resultant corrective and preventative actions taken.回顧所有重大偏差或不符合事件與相關(guān)調(diào)查，以及后續(xù)糾正與預(yù)防措施的有效性。任何偏差得到了完整記錄和調(diào)查；v. the finished products contain active ingredients plying with the qualitative and quantitative position of the marketing authorisation, are of the purity required, and are enclosed within their proper containers and correctly labelled。降低產(chǎn)品銷售過程中的質(zhì)量風(fēng)險(xiǎn)；ix. a system is available to recall any batch of product, from sale or supply。 適 當(dāng) 的 設(shè) 備 及 保 養(yǎng) ；d. correct materials, containers and labels。藥品貯存 、發(fā)運(yùn)和后續(xù)處理確保有滿意的管理規(guī)程，從而盡量保證藥品貨架期內(nèi)的質(zhì)量ix. there is a procedure for selfinspection and/or quality audit, which regularly appraises the effectiveness and applicability of the quality assurance system.有自檢和 / 或質(zhì)量審計(jì)規(guī)程，以定期評價(jià)質(zhì)量保證體系的有效性與適用性。藥品的設(shè)計(jì)和開發(fā)應(yīng)考慮藥品生產(chǎn)質(zhì)量管理規(guī)范的要求；ii. production and control operations are clearly specified and Good Manufacturing Practice adopted。整個(gè)制藥質(zhì)量體 系應(yīng)當(dāng)配備充足的具有資質(zhì)的人員，以及充分并適用的建筑物、設(shè)備和設(shè)施。質(zhì)量體系應(yīng)當(dāng)全面文件化，并監(jiān)察其有效性。The system of Quality Assurance appropriate for the manufacture of medicinal products should ensure that: 一個(gè)適當(dāng)?shù)馁|(zhì)量保證體系應(yīng)當(dāng)確保：i. medicinal products are designed and developed in a way that takes account of the requirements of Good Manufacturing Practice 。質(zhì)量受權(quán)人需簽發(fā)證明以確認(rèn)每一批次藥品的生產(chǎn)和控制均符合上市許可要求以及與藥品生產(chǎn) 、控制和放行相關(guān)的任何其他法規(guī)要求，未經(jīng)質(zhì)量受權(quán)人簽發(fā)證明的藥品不得銷售或供貨；viii. satisfactory arrangements exist to ensure, as far as possible, that the medicinal products are stored, distributed and subsequently handled so that quality is maintained throughout their shelf life。 充足的廠房與空間 ；c. suitable equipment and services。生產(chǎn)記錄包括銷售記錄以易懂且可獲得的方式得到了保留，使整個(gè)批次的完整歷史可追溯；viii. the distribution (wholesaling) of the products minimises any risk to their quality。由手工和/ 或儀器做了記錄，以證明所有要求的取樣、檢查和檢驗(yàn)規(guī)程切實(shí)得到了執(zhí)行。iii. A review of all batches that failed to meet established specification(s) and their investigation.回顧未能符合既定質(zhì)量標(biāo)準(zhǔn)的所有批次及其調(diào)查結(jié)果。xi. The qualification status of relevant equipment and utilities, . HVAC, water, pressed gases, etc.回顧相關(guān)設(shè)備與公用系統(tǒng)的確認(rèn)狀態(tài)，例如空氣凈化系統(tǒng)、制水系統(tǒng)、壓縮空氣系統(tǒng)等?？梢圆捎们罢靶曰蚧仡櫺孕问健Ｋ腥藛T都應(yīng)當(dāng)知曉與自己相關(guān)的藥品生產(chǎn)質(zhì)量管理規(guī)范基本原則，并且接受培訓(xùn)與繼續(xù)培訓(xùn)，這些培訓(xùn)包括與人員衛(wèi)生相關(guān)的教育工作。生產(chǎn)負(fù)責(zé)人和質(zhì)量負(fù)責(zé)人必須相互獨(dú)立。. The head of the Quality Control Department generally has the following responsibilities:質(zhì)量負(fù)責(zé)人通常有以下職責(zé)：i. to approve or reject, as he sees fit, starting materials, packaging materials, and intermediate, bulk and finished products。Other duties of the Quality Control Department are summarised in Chapter 6. 質(zhì)量控制其他職責(zé)在第6 章中匯總描述。 plant hygiene。 216。 對物料與產(chǎn)品的貯存條件進(jìn)行確定和監(jiān)管；216。應(yīng)當(dāng)有培訓(xùn)計(jì)劃，培訓(xùn)