澳大利亚GMP中英对照.doc

治疗用产品委员会 澳大利亚医用产品良好生产规范 2002年8月16日 Chapter 1 QUALITY MANAGEMENT 质量管理 PRINCIPLE 原理 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. 制造权所有者必须生产医用产品以保证符合预期用途，与市场认可保持一致，并且不会由于不良的安全，质量及效果给患者带来风险。 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. 这些质量目标的达到不仅是高级管理人员的职责，而且需要公司很多不同的部门，各个层次的职员，以及供应商，销售商来参与并做出承诺。 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. 确保质量目标的达到必须有一个全面的策划及正确执行的质量保证体系，它由生产管理规范及质量控制结合而成。 It should be fully documented and its effectiveness monitored. 它应该充分的文件化并且监测它的效果。 All parts of the Quality Assurance systems should be adequately resourced with competent personnel, and suitable and sufficient premises, equipment and facilities. 质量保证体系的各个部分应该具备充分的资源，包括适当的人员，适宜的和充分的基础设施，设备和工具。 There are additional legal responsibilities for the holder of the manufacturing authorization and for the authorised person(s). 生产权所有人以及授权人具有附加的法律责任。 1.1. The basic concepts of Quality Assurance, Good Manufacturing Practice and Quality Control are inter-related. They are described here in order to emphasise their relationships and their fundamental importance to the production and control of medicinal products. 质量保证，生产规范，质量控制的基本理论是相互联系的，这里的描述是要强调它们对医用产品的生产的控制的联系及重要性。 QUALITY ASSURANCE 质量保证 1.2. Quality Assurance is a wide ranging concept which covers all matters which individually or collectively influence the quality of a product. 1.2质量保证是一个具有广泛含义的概念，覆盖所有单一的或共同的影响产品质量的事宜 It is the sum total of