국내외 혈액제제(혈액성분제제) 제조 및 품질관리 관련 규정(GMP) 비교를 통한 국내 규정의 개정 방안 연구

Study of the Improvement of Domestic Regulations through Comparison of Domestic and Foreign Blood Product (Blood Components) GMP Regulations

GMP for blood component preparations has been obliged to be applied to the blood component manufacturer (blood center) from January 2019. However, domestic regulations need revision for international harmonization with foreign regulations. Therefore, this study grasped the main items and technical level of domestic and foreign regulations and tried to understand the application of GMP in blood centers and to elaborate items to be supplemented by domestic regulations in relation to the technical specifications of foreign regulations. As a result of research, it was confirmed that there are differences between the domestic regulation and the foreign regulation regarding the necessary composition facilities, storage area, mobile site, and environmental composition part of the manufacturing area of the blood source. In addition, while domestic regulations only describe the use of closed systems as a basis for establishing unclearity of manufacturing areas in blood centers, foreign regulations require that aseptic connections be established for the construction of such closed systems and it is confirmed that the items that are essential to be verified at the time of verification are described. In conclusion, this study suggests measures for securing the safety of blood products based on the technical specifications of foreign regulations, and it is meaningful that the blood center supplemented the detailed technical details necessary for carrying out the GMP.