【正文】 iii. to ensure that 。 (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。 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(fù)責(zé)人 （一）資質(zhì)： 生產(chǎn)管理負(fù)責(zé)人應(yīng)當(dāng)至少具有藥學(xué)或相關(guān)專業(yè)本科學(xué)歷（或中級(jí)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(shí)踐經(jīng)驗(yàn) ，其中至少有一年的藥品生產(chǎn)管理經(jīng)驗(yàn)，接受過與所生產(chǎn)產(chǎn)品相關(guān)的專業(yè)知識(shí)培訓(xùn)。 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(fù)責(zé)人 企業(yè)負(fù)責(zé)人是藥品質(zhì)量的主要責(zé)任人，全面負(fù)責(zé)企業(yè)日常管理。質(zhì)量管理負(fù)責(zé)人和質(zhì)量受權(quán)人可以兼任。 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(yīng)當(dāng)為企業(yè)的全職人員，至少應(yīng)當(dāng)包括企業(yè)負(fù)責(zé)人、生產(chǎn)管理負(fù)責(zé)人、質(zhì)量管理負(fù)責(zé)人和質(zhì)量受權(quán)人。 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(zé)通常不得委托給他人。每個(gè)人所承擔(dān)的職責(zé)不應(yīng)當(dāng)過多。 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(yīng)當(dāng)配備足夠數(shù)量并具有適當(dāng)資質(zhì)（含學(xué)歷、培訓(xùn)和實(shí)踐經(jīng)驗(yàn)）的管理和操作人員，應(yīng)當(dāng)明確規(guī)定每個(gè)部門和每個(gè)崗位的職責(zé)。 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(yīng)當(dāng)參與所有與質(zhì)量有關(guān)的活動(dòng)，負(fù)責(zé)審核所有與本規(guī)范有關(guān)的文件。 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(yīng)當(dāng)設(shè)立獨(dú)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(zé)。 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(fēng)險(xiǎn)管理過程所采用的方法、措施、形式及形成的文件應(yīng)當(dāng)與存在風(fēng)險(xiǎn)的級(jí)別相適應(yīng)。 (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(fēng)險(xiǎn)管理 Section 4 Quality risk management 第十三條 質(zhì)量風(fēng)險(xiǎn)管理是在整個(gè)產(chǎn)品生命周期中采用前瞻或回顧的方式，對(duì)質(zhì)量風(fēng)險(xiǎn)進(jìn)行評(píng)估、控制、溝通、審核的系統(tǒng)過程。 (v) records of sampling, inspecting and testing shall be made, any deviations shall be fully recorded and investigated。 (iii) samples of starting materials, packaging materials, intermediate products, bulk products and finished products are taken by qualified personnel and by approved method。 Article basic requirements of Quality Control are that: (i) adequate facilities, equipments, instruments and trained personnel are available to plete all related quality control activities effectively and reliably。 (x) plaints about marketed products are examined, the causes of quality defects are investigated and appropriate measures are taken in respect of the defective products to prevent reoccurrence. 第三節(jié) 質(zhì)量控制 Section 3 Quality Control 第十一條 質(zhì)量控制包括相應(yīng)的組織機(jī)構(gòu)、文件系統(tǒng)以及取樣、檢驗(yàn)等，確保物料或產(chǎn)品在放行前完成必要的檢驗(yàn)，確認(rèn)其質(zhì)量符合要求。 (viii) the distribution of the medicinal products minimize any risk to their quality。 (vi) production records shall be documented, any deviations are fully recorded and investigated。 (iv) instructions and procedures are written in an instructional form in clear and unambiguous language。 e. approved process procedures and operation procedures。 c. suitable equipments and services。 (iii) all necessary resources are provided, including at least: a. appropriately qualified and trained personnel。 Article 10. The basic requirements of GMP are that: (i) all manufacturing processes are clearly defined, systematically reviewed and shown to be capable of consistently manufacturing medicinal products of the required quality。 (x) there is a procedure for SelfInspection and/or quality audit, which regularly appraises the effectiveness and applicability of the Quality Assurance system. 第十條 藥品生產(chǎn)質(zhì)量管理的基本要求： （一）制定生產(chǎn)工藝，系統(tǒng)地回顧并證明其可持續(xù)穩(wěn)定地生產(chǎn)出符合要求的產(chǎn)品； （二）生產(chǎn)工藝及其重大變更均經(jīng)過驗(yàn)證； （三）配備所需的資源，至少包括： ； 2.足夠的廠房和空間； ； 、包裝材料和標(biāo)簽； ； 。 (viii) each production batch of medicinal products should not be released before the approval of the qualified person。 (vi) all qualification and validation are carried out。 (iv) arrangements are made for the manufactu