【導讀】revision)》Reviewed. 目錄TableofContents第一章總

　　

【正文】 iate products, bulk products and finished products are taken by qualified personnel and by approved method。 (iv) test methods are validated or qualified。 (v) records of sampling, inspecting and testing shall be made, any deviations shall be fully recorded and investigated。 (vi) materials, intermediate, bulk products and finished products shall be inspected and tested according to quality standards, and the process and results shall be recorded。 (vii) sufficient reference samples of materials and products are retained to permit future examination of the product if necessary and that the product is retained in its final pack unless exceptionally large packs are produced. 第四節(jié) 質(zhì)量風險管理 Section 4 Quality risk management 第十三條 質(zhì)量風險管理是在整個產(chǎn)品生命周期中采用前瞻或回顧的方式，對質(zhì)量風險進行評估、控制、溝通、審核的系統(tǒng)過程。 Article13. Quality risk management is a systematic process for the assessment, control, munication and review of risks to the quality of the medicinal product. It can be applied both proactively and retrospectively. 第十四條 應當根據(jù)科學知識及經(jīng)驗對質(zhì)量風險進行評估，以保證產(chǎn)品質(zhì)量。 Article 14. The evaluation of the risk to quality is based on scientific knowledge and experience with the process to ensure the product quality. 第十五條 質(zhì)量風險管理過程所采用的方法、措施、形式及形成的文件應當與存在風險的級別相適應。 Article 15. The level of method, action, formality and documentation of the quality risk management process is mensurate with the level of risk 第三章 機構(gòu)與人員 Chapter 3 Organization and personnel 第一節(jié) 原 則 Section 1 principle 第十六條 企業(yè)應當建立與藥品生產(chǎn)相適應的管理機構(gòu)，并有組織機構(gòu)圖。 Article 16. The manufacturer shall establish management anisation which is patible with the production. The manufacturer must have an anisation chart. 企業(yè)應當設立獨立的質(zhì) 量管理部門，履行質(zhì)量保證和質(zhì)量控制的職責。質(zhì)量管理部門可以分別設立質(zhì)量保證部門和質(zhì)量控制部門。 A manufacturer should establish an independent quality management department responsible for quality assurance (QA) and quality control (QC). The quality management department can set up the QA and QC section separately. 第十七條 質(zhì)量管理部門應當參與所有與質(zhì)量有關(guān)的活動，負責審核所有與本規(guī)范有關(guān)的文件。質(zhì)量管理部門人員不得將職責委托給其他部門的人員。 Article 17. The quality unit(s) should be involved in all qualityrelated activities and responsible for all appropriate qualityrelated documents review and approval. Responsibilities of quality management person may not be delegated to others department. 第十八條 企業(yè)應當配備足夠數(shù)量并具有適當資質(zhì)（含學歷、培訓和實踐經(jīng)驗）的管理和操作人員，應當明確規(guī)定每個部門和每個崗位的職責。崗位職責不得遺漏，交叉的職責應當有明確規(guī)定。每個人所承擔的職責不應當過多。 所有人員應當明確并理解自己的職責，熟悉與其職責相關(guān)的要求，并接受必要的培訓，包括上崗前培訓和繼續(xù)培訓。 Article18. The manufacturer should have an adequate number of management and operation personnel with the necessary qualifications (education, training and practical experience). The responsibility for every department or every position shall be clearly defined. There should be no gaps in job descriptions. Overlaps responsibilities shall be clearly definition. The responsibilities placed on any one individual should not be so extensive. Individual responsibilities should be clearly understood by the individuals and recorded. All personnel should be familiar with the requirements relate to their responsibilities and receive initial and continuing training, relevant to their needs. 第十九條 職責通常不得委托給他人。確需委托的，其職責可委托給具有相當資質(zhì)的指定人員。 Article19. The duties usually may not be delegated to others. If necessary, it may be delegated to designated personnel of a satisfactory qualification level. 第二節(jié) 關(guān)鍵人員 Section 2 Key Personnel 第二十條 關(guān)鍵人員應當為企業(yè)的全職人員，至少應當包括企業(yè)負責人、生產(chǎn)管理負責人、質(zhì)量管理負責人和質(zhì)量受權(quán)人。 質(zhì)量管理負責人和生產(chǎn)管理負責人不得互相兼任。質(zhì)量管理負責人和質(zhì)量受權(quán)人可以兼任。應當制定操作規(guī)程確保質(zhì)量受權(quán)人獨立 履行職責，不受企業(yè)負責人和其他人員的干擾。 Article 20. Normally key posts should be occupied by fulltime personnel. Key Personnel include at least the head of Manufacturer, the head of Production, the head of Quality Management and the Qualified Person. The heads of Production and Quality Management must be independent from each other. Qualified person and the head of Quality Management can be the same personnel. Procedure shall be established to ensure the qualified persons can carry out their duties independently without disrupted by the head of Enterprise and other personnel. 第二十一條 企業(yè)負責人 企業(yè)負責人是藥品質(zhì)量的主要責任人，全面負責企業(yè)日常管理。為確保企業(yè)實現(xiàn)質(zhì)量目標并按照本規(guī)范要求生產(chǎn)藥品，企業(yè)負責人應當負責提供必要的資源，合理計劃、組織和協(xié)調(diào)，保證質(zhì)量管理部門獨立履行其職責。 Article 21. Head of Manufacturer The head of manufacturer is the main responsible person for drug quality and prehensively responsible for routine management of a manufacturer. In order to ensure the achievement of quality objectives and the drug produced in pliance with this Practice, the head of manufacturer has responsibility of providing the necessary resources, reasonable plans, anization and coordination to ensure that the quality management department performs its duties independently. 第二十二條 生產(chǎn)管理負責人 （一）資質(zhì)： 生產(chǎn)管理負責人應當至少具有藥學或相關(guān)專業(yè)本科學歷（或中級專業(yè)技術(shù)職稱或執(zhí)業(yè)藥師資格），具有至少三年從事藥品生產(chǎn)和質(zhì)量管理的實踐經(jīng)驗 ，其中至少有一年的藥品生產(chǎn)管理經(jīng)驗，接受過與所生產(chǎn)產(chǎn)品相關(guān)的專業(yè)知識培訓。 Article 22. The head of the Production Department (1)Qualification: The responsible person of the manufacturing management must, at a minimum, have an educational qualification of an undergraduate course in pharmacy or related sciences (or with a technical title at middle grade or a qualification of licensed pharmacist) and also at least threeyears practical experience in management of drug production and quality, of which minimal one year practical experience in management of drug production, and have received professional training in relevant products manufactured. （二）主要職責： 、貯存，以保證藥品質(zhì)量； 與生產(chǎn)操作相關(guān)的各種操作規(guī)程； 審核并送交質(zhì)量管理部門； ，以保持其良好的運行狀態(tài)； ； 前培訓和繼續(xù)培訓，并根據(jù)實際需要調(diào)整培訓內(nèi)容。 (2) The head of production department generally has the following responsibilities: i. to ensure that products are produced and stored according to the approved process instructions in order to obtain the required quality。 ii. to ensure that the instructions relating to production operations are carried out strictly。 iii. to ensure that