Objective To study a way to establish a drug inspection evaluation system in China.Methods Through literature research,behavioral event interviews,Delphi expert interviews,and other methods,the theory of“threedimensi...Objective To study a way to establish a drug inspection evaluation system in China.Methods Through literature research,behavioral event interviews,Delphi expert interviews,and other methods,the theory of“threedimensional quality structure model”was used to extract,screen,and construct a set of evaluation indicator system for drug inspection,including 3 first-level indicators,11 second-level indicators,and 47 third-level indicators.Results and Conclusion An effective management tool to evaluate the quality of drug inspection has not yet been formed in China.According to the requirements of laws,regulations,and departmental rules,combined with the mature drug inspection mechanism of international drug regulatory agencies or organizations and the international quality management theory,some management tools are put forward to improve the quality system of drug supervision.展开更多
文摘Objective To study a way to establish a drug inspection evaluation system in China.Methods Through literature research,behavioral event interviews,Delphi expert interviews,and other methods,the theory of“threedimensional quality structure model”was used to extract,screen,and construct a set of evaluation indicator system for drug inspection,including 3 first-level indicators,11 second-level indicators,and 47 third-level indicators.Results and Conclusion An effective management tool to evaluate the quality of drug inspection has not yet been formed in China.According to the requirements of laws,regulations,and departmental rules,combined with the mature drug inspection mechanism of international drug regulatory agencies or organizations and the international quality management theory,some management tools are put forward to improve the quality system of drug supervision.
