미국 및 유럽의 의약품 GMP 실사 동향 연구

Pharmaceutical GMP Inspection: Case Study of USA and EU

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.