Exploring risk factors and improvement strategies for quality management in non-clinical drug safety evaluation institutions based on on-site inspections
YUAN Ming
CHEN Yi-fei
Abstract：Objective:To develop a practical methodology for risk identification and quality improvement in the quality management system of non-clinical drug safety research institutions,i.e.,Good Laboratory Practice(GLP)institutions,by identifying and analyzing the distribution of key factors in the operation and management of GLP institutions.Methods:Certain inspection fundings from different inspection types,including initial certification inspections,renewal certification inspections,and inspections for newly added test items,were used as analyzing items.Based on the demo data,key factors are identified and categorized,and the Pareto principle was applied to determine the main risk factors in the quality management of GLP institutions.Based on this,a risk identification model was constructed using externally identified inspection findings to enhance the level of quality management.Conclusion:By identifying and categorizing key factors,and utilizing findings from external inspections as the data foundation,this model serves as a tool for semi-quantitative analysis of quality management risk factors.It provides a reference framework for the digital transformation of quality management and facilitates risk management.
Keywords：non-clinical drug safety evaluation institutiondigital quality managementrisk managementmodel pathway
Publication Date：2026-07-30
Online Publishing Date：2026-08-14(First online date of this platform, not the publication date of the document)
Pages：6( 1472-1477 )