药用产品GMP指南第一部分翻译.docx

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 TOC \o 1-3 \h \z \u 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 69  CHAPTER 1 第一章 质量管理 QUALITY MANAGEMENT PRINCIPLE 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 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 reliably there 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 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 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、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 Practice, Quality Control and Quality Risk Management are inter-related. They are described here in order to emphasise th