药品监管部门建立质量管理体系的实施路径

Approach to Establishing Quality Management System by Drug Regulatory Authority

建立并运行监管质量管理体系是药品监管部门保证监管活动达到预期目的、持续提升工作质量和效率的必由之路。当前药品监管部门建立质量管理体系面临着缺乏专职质量管理队伍、体系标准语言晦涩难懂、质量管理观念有待转变、体系与业务存在"两张皮"等工作难点。为此,药品监管部门按照做好顶层设计、做好组织保障、明确体系范围、积极借用外脑、抓好宣贯培训、抓好体系调研、制定方针目标、编制体系文件的实施路径开展质量管理体系建立工作。

The establishment and implementation of a regulatory quality management system(QMS)is the only way for drug regulatory authorities to deliver regulatory objectives and continuously improve the quality and efficiency of regulation.Currently,drug administrative departments face a series of challenges in establishing QMS,such as the lack of full-time quality management team,difficulty in understanding the terminology,lack of quality management concept,and disconnection between QMS and daily work.To tackle these problems,Guangdong Medical Products Administration adopted active approaches to QMS building,including developing a top-down design,providing good organizational support,clarifying the scope of the system,working with an outside consulting firm,paying attention to publicity and training,conducting thorough research,formulating plans and objectives,and compiling quality system documents.