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GUIDE TO GOOD MANUFACTURING PRACTICE FOR MEDICINAL PRODUCTS 国际药品审计合作组织(PIC/S) 药品生产质量管理规范指引 主办单位：卫生署药政处、药物食品检验局 协办单位：经济部工业局 承办单位：社团法人台湾药物质量协会 日期：2003年CHAPTER 1 QUALITY MANAGEMENT 第一章 质量管理 PRINCIPLE The holder of a manufacturing authorization must manufacture medicinal products so as to ensure that they are fit for their intended use, comply with the requirements of the marketing authorization 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. 原则 制造许可证的持有者，应遵循上市许可的要求去制造药品，以确保药品适合其所预期的用途，并且，不会由于不适当的安全性、质量或有效性而使病人受到危害。这种质量目标的达成，是高层管理者的责任，而且需要由公司之内的许多不同部门以及所有阶层之人员的参与及承诺，也需要公司的供货商以及经销商的参与及承诺。 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 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 authorization and for the authorised person(s). 要可靠地达成这个质量目标，应有经过全面设计和正确实施的质量保证系统, 该系统涵盖药品生产质量管理规范与质量控制。它应完全文件化，并且要监督它的效果。质量保证系统的所有部门，应适当配置权责人员，也要有合适而且足够的厂房、设备与设施。对于制造许可证的持有者以及被授权的人员，须另负其它法律责任。 1.1. The basic concepts of Quality Assurance, Good Manufacturing Practice and Quality Control are inter-related. They are described here in order to emphasis their relationships and their fundamental importance to the production and control of medicinal products. 1.1. 质量保证、药品生产质量管理规范和质量控制的基本观念，是相互关联的，故在本章中叙述，以强调其彼此间的关系及其对药品之生产和控制的重要性。 QUALITY ASSURANCE 1.2. Quality Assurance is a wide ranging conce