earticle

영어

This study analyzes and compares the major GMP violations and patterns observed in South Korea and Japan based on FDA inspection data from 2009 to 2023. Rather than simply examining the frequency of violations, this research introduces keyword network analysis—a method rarely applied in regulatory science to explore the interrelations and structural characteristics among violation categories in greater depth. The results indicate that in South Korea, violations related to laboratory control and documentation were prominent, with labeling issues and the absence of laboratory systems closely linked to other quality concerns. These findings highlight the need for strengthened data integrity and quality systems. In contrast, Japan showed a higher prevalence of violations in production processes, storage, and equipment management, with significant associations observed particularly in sterilization processes and approval procedures. By visualizing the results through keyword network mapping, this study clarifies regulatory vulnerabilities in each country and offers a novel analytical framework for understanding complex violation patterns. These insights can serve as foundational data for developing proactive strategies in response to FDA inspections and may contribute to the establishment of quality management systems aligned with global regulatory standards.