OBJECTIVE： To strengthen comprehensive management and control of drug quality risk so as to guarantee the safety of drug use. METHODS： The steps and effects of drug quality risk management in our hospital were introduced according to hazard analysis and critical control point （HACCP）. RESULTS： Our hospital started with the establishment of working team， drew out drug flow plot and formulated the plan according to HACCP [including hazard analysis， confirming critical control point （CCP） and establishing critical limit （CL）， monitoring system， correcting measures， confirmation procedure and quality record]. Ultimately， 4 CCPs were determined， which were temperature and humidity dissatisfaction of drug storing environment， disorder of drug storing or unclear label， expired drugs arrayed on pharmacy storage or nurse station and use of unqualified drug. The implementation of above management obtained effective management and control of every link. There was no hazardous accident and complaint caused by drug quality problem in our hospital in 3 years after HACCP implemented. By comparison， 10 accidents involving CCPs were recorded in 6 years before HACCP implemented. CONCLUSIONS： Reasonable application of HACCP can effectively control drug quality risk and promote the safety of drug use in patients.