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1、PHARMACEUTICAL INSPECTION CONVENTION PHARMACEUTICAL INSPECTION CO-OPERATION SCHEME药品检验公约药品检验合作计划GUIDE TO GOOD MANUFACTURING PRACTICE FOR MEDICINAL PRODUCTS PART I药用产品良好生产规范指南第一部分目录第一章 质量管理2第二章人员11第三章 厂房设施17第四章 文件25第五章 生产41第六章质量控制53第七章 委托生产与委托检验62第八章 产品投诉和召回66第九章 自检69CHAPTER 1 第一章 质量管理QUALITY MANAGEM
2、ENTPRINCIPLE 原则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 at
3、tainment 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
4、must be a comprehensively designed and correctly implemented system of Quality Assurance Incorporating Good Manufacturing Practice, and thus Quality Control and Quality Risk Management. It should be fully documented and its effectiveness monitored. All parts of the Quality Assurance systems should b
5、e 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 authorised person(s). 生产许可证持有人必须生产药品，从而确保药品适合预期用途、符合相应的上市许可证或临床试验许 可证要求，不因为安全性问题、
6、质量问题或有效性问题而把患者置于风险之中。实现上述质量目标是公司高级管理人员的职责，并要求公司的供应商、销售商，公司内所有各级员工与许多不同部门的员工共同参与、一起努力。要可靠地实现这一质量目标，必须综 合设计一个整合药品生产质量管理规范（GMP）和质量控制、质量风险管理的制药质量保证体系并正确实施。质量体系应当全面文件化，并监察其有效性。整个制药质量体 系应当配备充足的具有资质的人员，以及充分并适用的建筑物、设备和设施。生产许可证持有人以及质量受权人有额外的法律责任。The basic concepts of Quality Assurance, Good Manufacturing Pra
7、ctice, Quality Control and Quality Risk Management 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.质量保证、药品生产质量管理规范、质量控制以及质量风险管理的基本概念是相互关联的。在这里对其进行描述是为了强调它们之间的联系以及其对药品生产和控制的重要性。QU
8、ALITY ASSURANCE质量保证1.1 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 organised arrangements made with the objective of ensuring that medicinal products are of the quality requir
9、ed for their intended use. Quality Assurance therefore incorporates Good Manufacturing Practice plus other factors outside the scope of this Guide.质量保证是一个宽泛的概念，涵盖所有因素，这些因素单独或共同影响产品质量。质量保证是为了保证药品质量符合预期用途，而进行的有组织的安排的总和。因此，质量保证中包含着药品生产质量管理规范以及本指南的范围内的其他因素。The system of Quality Assurance appropriate for
10、 the manufacture of medicinal products should ensure that: 一个适当的质量保证体系应当确保：i. medicinal products are designed and developed in a way that takes account of the requirements of Good Manufacturing Practice ;药品的设计和开发应考虑药品生产质量管理规范的要求；ii. production and control operations are clearly specified and Good Ma
11、nufacturing Practice adopted;对生产和控制操作进行明确规定，并符合药品生产质量管理规范的要求；iii. managerial responsibilities are clearly specified;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; 对下述活动均有协议约束：生产、供应、使用正确的起始物料与包装材料。v. all necessary controls on in
12、termediate products, and any other inprocess controls and validations are carried out;对中间产品以及其他任何中间过程控制与验证实施所有必要的控制；vi. the finished product is correctly processed and checked, according to the defined procedures;成品根据确定的程序进行正确生产和检测；vii. medicinal products are not sold or supplied before an authorise
13、d 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, control and release of medicinal products;质量受权人需签发证明以确认每一批次药品的生产和控制均符合上市许可要求以及与药品生产 、控制和放行相关的任何其
14、他法规要求，未经质量受权人签发证明的药品不得销售或供货；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;药品贮存 、发运和后续处理确保有满意的管理规程，从而尽量保证药品货架期内的质量ix. there is a procedure for
15、self-inspection and/or quality audit, which regularly appraises the effectiveness and applicability of the quality assurance system.有自检和 / 或质量审计规程，以定期评价质量保证体系的有效性与适用性。GOOD MANUFACTURING PRACTICE FOR MEDICINAL PRODUCTS (GMP)药品生产质量管理规范1.2 Good Manufacturing Practice is that part of Quality Assurance w
16、hich ensures that Medicinal products are consistently produced and controlled to the quality standards appropriate to their intended use and as required by the marketing authorisation or product specification. Good Manufacturing Practice is concerned with both production and quality control. The basic requirements of GMP are that:药品生产质量管理规范是质量管理体系的一部分，保证按适合预期用途的质量标准及上市许可、临床试验许
