OBJECTIVE To provide reference for aseptic drug production enterprises to improve production quality management and drug production supervision.METHODS Summarize and analyze the defects found in the supervision and inspection of 40 sterile drug production enterprises in Anhui Province in 2022.RESULTS Among the 40 sterile drug production enterprises with defect projects,quality control and assurance,document management,and sterile drug appendices had the most defects,accounting for 29.69％,13.20％,and 12.78％of the total defect projects,respectively.There is only one enterprise with serious defects,and confirmation and verification account for a high proportion of the main defects.CONCLUSION Enterprises should actively improve the production and quality management level of sterile drugs;Regulatory authorities should unify the inspection scale,conduct personalized in-spections based on risks,conduct scientific supervision,assist in the development of enterprises,and effectively safe-guard the medication safety of the people.
NETL
NSTL
万方数据
