Systematization of 131I radiopharmaceutical production facility improvement plan

Because radioisotopes are treated, radiopharmaceuticals are classified as exceptions to GMP, but GMP should be applied from 2018 because the Pharmaceutical Affairs Law was amended. The Korea Atomic Energy Research Institute is the sole producer of radiopharmaceuticals for pediatric cancer treatment. In order to continue the supply, the radiopharmaceutical manufacturing facility should be improved to GMP. The Korea Atomic Energy Research Institute produces radiopharmaceutical in bank-3 capable zone of handling I-131. This zone should be improved to enable GMP application so that the radiopharmaceuticals can be continuously supplied. In order to improve bank-3, it is necessary to change the division, secure cleanliness, and expand additional facilities. To do this, we set up the bank-3 improvement plan and completed preparations for construction. And, we purchased the required equipment, completed the qualification, and obtained licenses. The application of GMP will serve as an opportunity to improve the quality standards of radiopharmaceuticals, which ultimately results in the safe administration of pediatric cancer patients. In addition, if the system is developed into an efficient system through continual improvement of GMP, it will be able to develop into a standard technology representing the international market