欧盟GMP中英文对照.doc

The rules governing medicinal products in the European Union药品生产质量管理规范 European Union药品生产质量管理规范GUIDE TO GOOD MANUFACTURING PRACTICE FOR MEDICINAL PRODUCTS目 录第一章 质量管理CHAPTER 1: QUALITY MANAGEMENT原则. . . .5Principle.5质量保证. . . 5Quality Assurance. 5药品生产质量管理规范(GMP).7Good Manufacturing Practice for Medicinal Products.7质量控制(QC) .9Quality Control. .9产品质量回顾. . .10第二章人员CHAPTER 2: PERSONNEL. .11原则.11Principle.11通则. 12General. .12 关键人员. .12Key Personnel.12培训. 12Training. .15人员卫生.16Personnel Hygiene.16 第三章厂房和设备CHAPTER 3: PREMISES AND EQUIPMENT. .18 原则.18Principle.18 厂房.18Premises.18通则.18General.18生产区.19Production Area.19贮存区.21Storage Area.21 质量控制区.22Quality Control Area.22附助区.22Ancillary Areas.22设备.23Equipment.23 第四章 文件CHAPTER 4: DOCUMENTATION.24原则.24Principle.24 通则.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 生产CHAPTER 5: PRODUCTION. . .36 原则. .36Principle.36通则. . 36General.36生产过程中对交叉污染的预防.39Prevention of Cross-contamination in Production.39 验证. .40Validation. .40 原料. .41Starting Materials. .41 生产操作：中间产品和待包装产品.42Processing Operations: Intermediate and Bulk Products.42包装材料. .43Packaging Materials. .43包装操作. .44Packaging Operations. .44成品. .46Finished Products. .46 不合格、回收料和退货物料.46Rejected, Recovered and Returned Materials.46第六章质量控制CHAPTER 6: QUALITY CONTROL.48 原则. .48Principle. .48通则. .48General. .48质量控制实验室规范.49Good Quality Control Laboratory Practice.49Documentation.49Sampling. .50Testing. .52销售产品的稳定性考察.54第七章 委托生产与委托检验CHAPTER 7: CONTRACT MANUFACTURE AND ANALYSIS.55 原则. .55Principle. .55 通则. .56General. .56委托方. .56The Contract Giver. .56 受托方. .57The Contract Acceptor. .57合同. .58The Contract. .58第八章 投诉与召回CHAPTER 8: COMPLAINTS AND PRODUCT RECALL.59原则. .59Principle. .59投诉. .59Complaints. .59召回.60Recalls.60第九章自查CHAPTER 9: SELF INSPECTION.61原则.61Principle.61附件8原辅料和包装材料的取样ANNEX8 SAMPLING OF STARTING AND PACKAGING MATERIALS.63原则.63Principle.63人员.63Personnel.63原辅料.63Starting materials.64包装材料.65Packaging material.65第一章 质量管理CHAPTER 1 QUALITY MANAGEMENTPrinciple原则生产许可证持有厂家只能生产医药产品，以确保药品符合其预期的使用目的，符合销售许可证的要求，并不因药品安全性、质量或药效方面的问题而给患者带来风险。达到这一质量目标是高层管理者的责任，同时也需要公司各部门、各层次的职员以及公司的供应商和销售商的参与并承担义务。为了确保达到该质量目标，必须全面设计并正确贯彻实施包括GMP与质量控制(QC)在内的质量保证(QA)体系。该体系应用文件明文规定并对其有效性加以监控。质量保证体系的所有部门都必须充分配备胜任的人员，适宜足够的厂房、设备及设施。与此同时，生产许可证持有者及受权人员具有另外的法律责任。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.质量保证、GMP和质量控制的基本概念是内在相互联系的。这里叙述的主要目的是强调它们之间的关系以及药品生产和控制中的重要性。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质量保证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.质量保证是一个宽泛的概念，它包括影响产品质量的所有问题，是确保药品质量符合预期使用目的而进行组织管理的总和。因此质量保证是由GMP本规范之外的其他因素所组成。The system of Quality Assurance appropriate for the manufacture of medicinal products should ensure that:质量保证体系对于药品的生产而言，应保证：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.药品的设计与开发应按照GMP和GLP的要求进行；ii. production and control operations are clearly specified and Good Manufacturing Practice adopted;ii.生产和控制操作应有明确规定，并采用GMP；iii. managerial responsibilities are clearly specified;iii.明确规定管理职责；iv. arrangements are made for the manufacture, supply and use of the correct starting and packaging materials;iv.安排生产、供应和使用正确的原、辅、包材料；v. all necessary controls on intermediate products, and any other in-process controls and validations are carried out;v.对中间产品进行必要的控制、进行其他任何过程控制和验证；vi. the finished product is correctly processed and checked, according to the defined procedures;vi.按照规定的程序，正确地加工与核查成品；vii. medicinal products are not sold or supplied before a Qualified Person has certified that each production batch has been produced and controlled in accordance with the requirements of the Marketing Authorisation and any other regulations relevant to the production, contro