澳大利亚GM中英对照.docVIP

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 a