质量体系--有效质量管理体系的关键2--奥星.pdfVIP

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： • Fi