第一章 质量管理 一、原则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 company’s suppliers and by the distributors. To achieve the quality objective in a reliable manner 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。The basic concepts of Quali...
