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1、第一章 质量管理 一、原则Principle Principle 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
2、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 attai
3、nment 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 in a reliable mann
4、er 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 resource
5、d 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。The basic conc
6、epts 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. 二、质量保证Quality Assurance Quality Assurance 1.2 质量保证是一个宽
7、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。Quality Assurance is a wide ranging concept which covers all matters which individually or collectively influence the quality of a product. It is the total sum of the organised arrangements made with the object of ensuring that
8、 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. 质量保证体系对于药品的生产而言， 应保证：The system of Quality Assurance appropriate for the manufacture of medicinal products
9、should ensure that: (1) 药品的设计与开发应按照GMP 和GLP 的要求进行；medicinal products are designed and developed in a way that takes account of the requirements of Good Manufacturing Practice and Good Laboratory Practice; (2) 生产和控制操作应有明确规定，并采用GMP； production and control operations are clearly specified and Good Manu
10、facturing Practice adopted; (3) 明确规定管理职责； managerial responsibilities are clearly specified; (4) 安排生产、供应和使用正确的原、辅、包材料； arrangements are made for the manufacture, supply and use of the correct starting and packaging materials; (5) 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； all necessary controls on intermediate pro
11、ducts, and any other in-process controls and validations are carried out; (6) 按照规定的程序，正确地加工与核查成品； the finished product is correctly processed and checked, according to the defined procedures; (7) 在受权人确认批产品按照销售许可证和其他与药品生产、检验和释放有关的法规要求进行生 产和质量控制，并签发合格证之前，药品不得销售或供应； medicinal products are not sold or s
12、upplied 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, control and release of medicinal products; (8) 尽可能对药品贮存、 销售及随后的处理做出满意的安
13、排， 以保证药品在货架寿命期内的质量； 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; (9) 建立自检和/或质量审计程序，定期对质量保证体系的有效性和适用性进行评价。there is a procedure for Self-Inspection
14、and/or quality audit which regularly appraises the effectiveness and applicability of the Quality Assurance system. 三、药品生产质量管理规范(GMP)Good Manufacturing Practice for Medicinal Products Good Manufacturing Practice for Medicinal Products 1.3 GMP 是质量保证的一部分， 它确保药品始终按照适合于其使用目的的质量标准进行生产和控 制，并符合销售许可证的要求。 1.
15、3 Good Manufacturing Practice is that part of Quality Assurance which ensures that 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. GMP 涉及生产和质量控制，其基本要求如下： Good Manufac
16、turing Practice is concerned with both production and quality control. The basic requirements of GMP are that: (1) 所有生产工艺应有明确规定，根据经验进行系统的审核，并证明能够始终如一地生产出符合 质量标准的药品。all manufacturing processes are clearly defined, systematically reviewed in the light of experience and shown to be capable of consistently manufacturing medicinal products of the required quality and complying with their specifications; (2) 应对生产工艺的关键步骤和工艺的重要变更进行验证。critical steps of
