歐盟GMP中英文對照.doc

.European Union藥品生產(chǎn)質(zhì)量管理規(guī)范GUIDE TO GOOD MANUFACTURING PRACTICE FOR MEDICINAL PRODUCTS目 錄第一章 質(zhì)量管理CHAPTER 1: QUALITY MANAGEMENT原則. . . .5Principle.5質(zhì)量保證. . . 5Quality Assurance. 5藥品生產(chǎn)質(zhì)量管理規(guī)范(GMP).7Good Manufacturing Practice for Medicinal Products.7質(zhì)量控制(QC) .9Quality Control. .9產(chǎn)品質(zhì)量回顧. . .10第二章人員CHAPTER 2: PERSONNEL. .11原則.11Principle.11通則. 12General. .12 關(guān)鍵人員. .12Key Personnel.12培訓. 12Training. .15人員衛(wèi)生.16Personnel Hygiene.16 第三章廠房和設(shè)備CHAPTER 3: PREMISES AND EQUIPMENT. .18 原則.18Principle.18 廠房.18Premises.18通則.18General.18生產(chǎn)區(qū).19Production Area.19貯存區(qū).21Storage Area.21 質(zhì)量控制區(qū).22Quality Control Area.22附助區(qū).22Ancillary Areas.22設(shè)備.23Equipment.23 第四章 文件CHAPTER 4: DOCUMENTATION.24原則.24Principle.24 通則.25General.25文件要求.27Documents Required.27Specifications.27Specifications for starting and packaging materials.27 Specifications for Intermediate and Bulk Products.27 Specifications for Finished Products.28Manufacturing Formulae and Processing Instructions.28Packaging Instructions.30Batch Processing Records.31Batch Packaging Records. .32Procedures and Records. .33 Receipt.34 Sampling.34Testing.35 Other.35 第五章 生產(chǎn)CHAPTER 5: PRODUCTION. . .36 原則. .36Principle.36通則. . 36General.36生產(chǎn)過程中對交叉污染的預防.39Prevention of Cross-contamination in Production.39 驗證. .40Validation. .40 原料. .41Starting Materials. .41 生產(chǎn)操作：中間產(chǎn)品和待包裝產(chǎn)品.42Processing Operations: Intermediate and Bulk Products.42包裝材料. .43Packaging Materials. .43包裝操作. .44Packaging Operations. .44成品. .46Finished Products. .46 不合格、回收料和退貨物料.46Rejected, Recovered and Returned Materials.46第六章質(zhì)量控制CHAPTER 6: QUALITY CONTROL.48 原則. .48Principle. .48通則. .48General. .48質(zhì)量控制實驗室規(guī)范.49Good Quality Control Laboratory Practice.49Documentation.49Sampling. .50Testing. .52銷售產(chǎn)品的穩(wěn)定性考察.54第七章 委托生產(chǎn)與委托檢驗CHAPTER 7: CONTRACT MANUFACTURE AND ANALYSIS.55 原則. .55Principle. .55 通則. .56General. .56委托方. .56The Contract Giver. .56 受托方. .57The Contract Acceptor. .57合同. .58The Contract. .58第八章 投訴與召回CHAPTER 8: COMPLAINTS AND PRODUCT RECALL.59原則. .59Principle. .59投訴. .59Complaints. .59召回.60Recalls.60第九章自查CHAPTER 9: SELF INSPECTION.61原則.61Principle.61附件8原輔料和包裝材料的取樣ANNEX8 SAMPLING OF STARTING AND PACKAGING MATERIALS.63原則.63Principle.63人員.63Personnel.63原輔料.63Starting materials.64包裝材料.65Packaging material.65第一章 質(zhì)量管理CHAPTER 1 QUALITY MANAGEMENTPrinciple原則生產(chǎn)許可證持有廠家只能生產(chǎn)醫(yī)藥產(chǎn)品，以確保藥品符合其預期的使用目的，符合銷售許可證的要求，并不因藥品安全性、質(zhì)量或藥效方面的問題而給患者帶來風險。達到這一質(zhì)量目標是高層管理者的責任，同時也需要公司各部門、各層次的職員以及公司的供應商和銷售商的參與并承擔義務。為了確保達到該質(zhì)量目標，必須全面設(shè)計并正確貫徹實施包括GMP與質(zhì)量控制(QC)在內(nèi)的質(zhì)量保證(QA)體系。該體系應用文件明文規(guī)定并對其有效性加以監(jiān)控。質(zhì)量保證體系的所有部門都必須充分配備勝任的人員，適宜足夠的廠房、設(shè)備及設(shè)施。與此同時，生產(chǎn)許可證持有者及受權(quán)人員具有另外的法律責任。The holder of a Manufacturing Authorisation must manufacture medicinal products so as to ensure that they are fit for their intended use, comply with the requirements of the Marketing Authorisation and do not place patients at risk due to inadequate safety, quality or efficacy. The attainment of this quality objective is the responsibility of senior management and requires the participation and commitment by staff in many different departments and at all levels within the company, by the companys suppliers and by the distributors. To achieve the quality objective reliably there must be a comprehensively designed and correctly implemented system of Quality Assurance incorporating Good Manufacturing Practice and thus Quality Control. It should be fully documented and its effectiveness monitored. All parts of the Quality Assurance system should be adequately resourced with competent personnel, and suitable and sufficient premises, equipment and facilities. There are additional legal responsibilities for the holder of the Manufacturing Authorisation and for the Qualified Person(s).1.1.質(zhì)量保證、GMP和質(zhì)量控制的基本概念是內(nèi)在相互聯(lián)系的。這里敘述的主要目的是強調(diào)它們之間的關(guān)系以及藥品生產(chǎn)和控制中的重要性。1.1.The basic concepts of Quality Assurance, Good Manufacturing Practice and Quality Control are inter-related. They are described here in order to emphasise their relationships and their fundamental importance to the production and control of medicinal products.Quality Assurance質(zhì)量保證1.2.Quality Assurance is a wide ranging concept which covers all matters which individually or collectively influence the quality of a product. It is the sum total of the organized arrangements made with the object of ensuring that medicinal products are of the quality required for their intended use. Quality Assurance therefore incorporates Good Manufacturing Practice plus other factors outside the scope of this Guide.1.2.質(zhì)量保證是一個寬泛的概念，它包括影響產(chǎn)品質(zhì)量的所有問題，是確保藥品質(zhì)量符合預期使用目的而進行組織管理的總和。因此質(zhì)量保證是由GMP本規(guī)范之外的其他因素所組成。The system of Quality Assurance appropriate for the manufacture of medicinal products should ensure that:質(zhì)量保證體系對于藥品的生產(chǎn)而言，應保證：i. medicinal products are designed and developed in a way that takes account of the requirements of Good Manufacturing Practice and Good Laboratory Practice;i.藥品的設(shè)計與開發(fā)應按照GMP和GLP的要求進行；ii. production and control operations are clearly specified and Good Manufacturing Practice adopted;ii.生產(chǎn)和控制操作應有明確規(guī)定，并采用GMP；iii. managerial responsibilities are clearly specified;iii.明確規(guī)定管理職責；iv. arrangements are made for the manufacture, supply and use of the correct starting and packaging materials;iv.安排生產(chǎn)、供應和使用正確的原、輔、包材料；v. all necessary controls on intermediate products, and any other in-process controls and validations are carried out;v.對中間產(chǎn)品進行必要的控制、進行其他任何過程控制和驗證；vi. the finished product is correctly processed and checked, according to the defined procedures;vi.按照規(guī)定的程序，正確地加工與核查成品；vii. medicinal products are not sold or supplied before a Q