Earticle

초록

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.

목차

Abstract
I. 서론
1. GMP(Good Manufacturing Practice)
2. FDA의 우수제조관리기준(CGMP)
II. 연구 방법
1. 연구자료
2. 자료수집
3. 분석방법
III. 연구 결과
1. 위반사항 빈도 분석
2. 키워드 네트워크 분석 (Keyword network analysis)
IV. 고찰 및 결론
참고문헌

키워드

저자

• 장선희 [ Seon-Hee Jang | 성균관대 약학대학 제약산업학과 ]
• 이상원 [ Sang-Won Lee | 성균관대 약학대학 제약산업학과 ] 교신저자

참고문헌

발행기관

간행물

표지보기 관심저널 등록

• 간행물명

  KFDC규제과학회지(구 FDC법제연구) [Regulatory Research on Food, Drug and Cosmetic]

• 간기

  반년간

• pISSN

  2799-8940

• 수록기간

  2006~2025

• 십진분류

  KDC 518 DDC 615