earticle

영어

This study was conducted to analyze the current status of Good Manufacturing Practice(GMP) implementation in the Korean pharmaceutical industry and to propose directions for future system improvement. To this end, relevant domestic and international GMP literature and guidelines were reviewed and compared, and a survey was conducted targeting GMP practitioners. The results indicate that while the domestic GMP system is generally aligned with international standards, shortcomings remain in areas such as ensuring data integrity, digitalization and automation of manufacturing processes, and the application of risk-based quality management. In addition, practitioners commonly recognized the need to enhance the effectiveness of GMP education, strengthen communication systems with regulatory authorities, clarify inspection standards, and provide field-oriented technical support. Based on these findings, the study proposes policy measures such as the introduction of digital quality management systems, reinforcement of job-specific GMP training, improvement of inspectors' professional capabilities, and the establishment of tailored support systems for the industry. The results of this study are expected to serve as a foundational reference for enhancing the effectiveness of the domestic GMP system and strengthening the global competitiveness of the Korean pharmaceutical industry.