精选优质文档-倾情为你奉上ISPE-CCPIE CHINA CONFERENCE 2011 Quality System Key to the effective Quality Management System 质量体系有效质量管理体系的关键 Anwarul Haque, Validation Director, Austar 奥星公司验证总监 ISPE October 25-28 2011 Shanghai 1 Regulatory Perspective 法规问题 The holder of a Manufacturing Authorisation (MA) must manufacture medicinal products ensuring that: 生产许可证（MA）的持有人所生产的药品必须保证： Fit for their intended use符合预期用途 comply with the requirements
