A discussion on the practice, effect and proposal of proficiency testing program for pharmaceutical dissolution determination / 中国药学杂志

ABSTRACT

OBJECTIVE: To discuss the role of proficiency testing program for pharmaceutical dissolution determination in the capacity building of relevant laboratories. METHODS Based on the results of the two proficiency testing programs carried out in recent years, analyze the difference of the quality management and the level of dissolution determination among the participating laboratories and discuss on the way that the proficiency testing programs carried out in future. RESULT: There is difference among the laboratories in both the quality management and the level of dissolution determination, the "unsatisfactory" laboratories mainly concentrated in local drug control institutes and pharmaceutical manufacturers. The three "unsatisfactory" laboratories in the first program, took corrective and preventive measures, participated in the later program, and achieved "satisfactory" results. CONCLUSION: The proficiency testing program is effective in improving the dissolution determination capacity of the participating laboratories and is recommended to be conducted continually in the pharmaceutical industry.