Standardization of Production Technology and GMP Documentation for Radiopharmaceuticals in Korea: Addressing Challenges and Developing Solutions

다국어 초록 (Multilingual Abstract)

The development and clinical use of radiopharmaceuticals has been rapidly advancing, driven by the increasing demand for diagnostic and therapeutic applications in nuclear medicine. Despite significant progress, the standardization of production technologies and Good Manufacturing Practice (GMP) documentation for radiopharmaceuticals remains a critical challenge, particularly in balancing the needs of developed and developing countries. This study aims to analyze the status and issues in the production and clinical use of medical radioisotopes and radiopharmaceuticals in South Korea, highlight the necessity of standardized production technologies, and propose solutions to enhance GMP compliance and documentation efficiency. Through comprehensive research, including a detailed examination of existing production technologies, quality management processes, and regulatory requirements, we developed standardized guidelines and an IT based document management system. These solutions are intended to improve production efficiency, ensure regulatory compliance, and ultimately enhance the quality and safety of radiopharmaceuticals.