미국 및 유럽의 의약품 GMP 실사 동향 연구

• 영문명: Pharmaceutical GMP Inspection: Case Study of USA and EU
• 발행기관: 대한약학회
• 저자명: 반은미(Eunmi Ban) 장동진(Dong-Jin Jang) 권택현(Taek-Hyun Kwon) 김애리(Aeri Kim)
• 간행물 정보: 『약학회지』제63권 제1호(2019년), 15~23쪽, 전체 9쪽
• 주제분류: 의약학 > 기타의약학
• 파일형태: PDF
• 발행일자: 2019.01.30

영문 초록

The Korea’s Ministry of Food and Drug Safety (MFDS) became a member of PIC/S in 2014, which would promote the Korean pharmaceutical companies produce reliable quality medicines with global standard. Therefore, the MFDS has been conducting continuous efforts for revising regulatory requirements including GMP inspection according to PIC/S GMP guideline. In this study, we have investigated databases of GMP inspection reports by the regulatory agencies of USA and EU, and analyzed GMP inspection deficiencies, including warning letters by US FDA and noncompliance reports by EU. We have found out that the outcomes of GMP inspections are made available online by both the USA and EU regulatory agencies to the regulators, the pharmaceutical company and the public. In addition, among various observed GMP deficiencies, quality control or management and documentation have been the most frequently observed differences, suggesting that these items should be carefully evaluated and managed in the manufacture of pharmaceutics. The results will serve as useful information for Korea pharmaceutical companies preparing GMP inspection by PIC/S member states and also for MFDS to derive global GMP inspection guidelines in the future.

목차

서 론(Introduction)

실험 방법(Experimental Methods)

결과 및 고찰(Results and Discussion)

결 론(Conclusion)

감사의 말씀(Acknowledgment)

References

키워드

GMP inspection deficiencies warning letter EudraGMDP database