Good Manufacturing Practices (GMP) for Blood and Blood Components, What Do You Know and How to Prepare? / 대한수혈학회지

ABSTRACT

Until recently, there was no formal regulation to cover the preparation of blood and blood components for transfusion in Korea; it was perceived as part of medical practice rather than the preparation of a biological therapeutic product. On the other hand, in accordance with the revision of the Korean Pharmaceutical Affairs Act, blood and blood components for transfusion have been under formal regulations enforced by the Ministry of Food and Drug Safety (MFDS) since January 2019. The regulation requires that blood establishments be licensed and subjected to regular inspection for good manufacturing practices (GMP) compliance. The preparation of blood and blood components is different from plasma-derived medicinal products (PDMPs) manufacturing and pharmaceutical medicines in general. Therefore, to accelerate the implementation of a regulatory system and reach an acceptable compliance status, blood establishments should be engaged to address the specific attributes of blood and blood components for transfusion.