In order to effectively improve the quality of infusions and ensure the safety of patients，Shijiazhuang No.4 Pharmaceutical Co.，Ltd. had implemented the comprehensive quality management of key quality indicators’ control for infusions，and innovatively combined modern technical means such as informationization and automation，through comprehensive and intensive research and analysis on the manufacturing process of infusion products and their APIs，pharmaceutical excipients and pharmaceutical packaging materials；and with the core of the whole staff，the whole chain，and all aspects，controlled the key quality indicators of insoluble particles and bacterial endotoxin through the implementation in six aspects—personnel，machines，materials，methods，phases and tests，so that the quality management system of key quality indicators’ control for infusions was established，which raised the product quality indicators to the international advanced level，effectively improving the economic and social benefits of the enterprise.