大容量注射剂的安全隐患及对策

Safety Hazards and Counterenasures of Large Capacity Injection

以风险评估为手段,分析大容量注射剂产生不良事件的原冈,阐述流通蒸汽灭菌的大容量注射剂产品,如何在现有的生产条件下,完善质量保证体系,保证药品的质量、疗效及用药安全。

The article analyzes courses of scandal caused by LVP procucts using risk analysis. It tells how the manufacturers shall improve the QA system and take proper actions so as to ensure that the LVP products do not place patients at risk due to inadequate safety, quality or efficacy.