Objective?To analyze and compare the domestic quality standard and foreign quality standard of sodium hyaluronate (HA), and to expatiate on the critical process monitoring parameters.?Methods?Different quality standards of HA were compared by translating and sorting, and some experimental data were analyzed as well as the manufacturing practice was elaborated.?Results? Differences exist in raw materials standard or specifications of products between domestic and foreign, but the basic control points are concordant.?Conclusion?The company should set up reasonable and controllable quality standard based on quality requirements and related process characteristics so as to assure the safety and effectiveness of the clinical application.
