Construction of competence model for GMP inspectors and empirical research
ZHAO Zhen-yu
ZHOU Xia
WU Zhi-ang
Abstract：Objective:To construct the competency model of drug GMP inspectors,and provide reference for construction of relevant system of drug GMP inspectors.Methods:the competency characteristics of drug GMP inspectors were investigated by means of questionnaire and expert interview.The research results were summarized and extracted,and the competency model of drug GMP inspectors was constructed.Then the method of empirical research was used to carry out a questionnaire survey of GMP inspectors in city B,and the reliability and validity of the survey results were analyzed.Results:The Cronbach's alpha coefficient of the questionnaire was 0.786,the KMO value was 0.797,and the Bartlett sphericity test was approximated by chi 2,and the value was 6 391.542 (P ＜0.000),and the total variance explained was 81.19％.Conclusion:the competency model through the Cronbach's alpha coefficient,KMO value test and Bartlett spherical degree test,the surface validity,content validity and structure validity is high.
Keywords：drug GMP inspectorcompetencemodelconstruction
Publication Date：2017-01-01
Online Publishing Date：2026-08-14(First online date of this platform, not the publication date of the document)
Pages：4( 1861-1864 )