COVID-19 팬데믹 전후 FDA 데이터 완전성 위반 분석: 경고서한 기반 비교 연구

• 영문명: Analysis of FDA Data Integrity Violations Before and After the COVID-19 Pandemic: A Comparative Study Based on Warning Letters
• 발행기관: 대한약학회
• 저자명: 박요석(Yoseok Park) 권경희(Kyenghee Kwon)
• 간행물 정보: 『약학회지』제69권 제3호(2025년), 291~300쪽, 전체 10쪽
• 주제분류: 의약학 > 기타의약학
• 파일형태: PDF
• 발행일자: 2025.06.30

국문 초록

This study examines 1,766 FDA warning letters issued between 2016 and 2023, with a focus on how the COVID-19 pandemic impacted data integrity violations within the pharmaceutical and biotechnology sectors. By comparing the pre-pandemic period (2016~2019) to the post-pandemic period (2020~2023), the research identifies notable increases in violations related to contemporaneous recordkeeping, accountability, and data availability. These increases were largely driven by the rapid transition to remote work and global supply chain disruptions, which exposed key vulnerabilities in data management systems. The study organizes these violations according to the ALCOA and ALCOA+ principles (Attributable, Legible, Contemporaneous, Original, Accurate, Completeness, Consistency, Endurance, and Availability). The pandemic significantly intensified FDA regulatory scrutiny, as more frequent and severe data integrity violations emerged, leading to stricter compliance requirements for pharmaceutical companies. In addition to analyzing the trends in FDA warning letters, the research also explores the broader implications for the South Korean pharmaceutical industry, highlighting the urgent need for companies to bolster their electronic data management systems, improve internal audit processes, and provide comprehensive staff training to align with global regulatory standards. Strengthening these areas is crucial for maintaining data integrity, ensuring regulatory compliance, and securing a competitive advantage in the international market. Ultimately, this study underscores the critical role of robust data management in a post-pandemic world, offering targeted recommendations to address the challenges exposed by the pandemic and ensuring that companies are well-equipped to meet the evolving demands of global pharmaceutical regulations.

목차

서 론(Introduction)

방 법(Methods)

결 과(Results)

고 찰(Discussion)

결 론(Conclusion)

감사의 말씀(Acknowledgment)

Conflict of Interest

References

키워드

Data Integrity FDA Warning Letters ALCOA/ALCOA+Principles COVID-19 Pandemic Good Manufacturing Practice (GMP) Quality Assurance

참고문헌

• Int J Pharm
• Biotechnol J
• Res J Pharm Technol
• Yakhak Hoeji
• KFDC J Regul Sci
• J. Korea Inst. Inf Commun Eng