ABSTRACT
OBJECTIVE: To identify the characteristics and application conditions of currently statistical methods for inter-laboratory comparison and proficiency testing results analysis in drug control, combining with the international standards and practical application. METHODS: Based on the ISO/IEC 17043-GB/T28043, start beging with the definition of outliers, the methods currently used in inter-laboratory comparison and proficiency testing results analysis both at home and abroad methods were summarized and compared according to the ISO/IEC 17043-GB/T28043, with focused on the testing the stability and repeatability of laboratory testing proficiency. The most-used stastical methods of mter-laboratory comparison and proficiency testing during present domestic and international drug testing was sumarrized and contratively analyzed. RESULTS: The application conditions of different methods good contrast were providedidentified application condition of methods. CONCLUSION: Robust Z-score has more advantages in current stage of inter-laboratory comparison and proficiency testing results analysis.
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.