Under the guiding principle of “quality first,” each plant periodically provides all employees with GMP training to ensure they have the necessary basic knowledge, including data integrity and appropriate behaviors. Each plant provides periodic training to GMP supervisors based on their position. We also provide new employees with introductory training and E-learning to help them understand the importance of GMP compliance at an early stage.

We proactively ensure consistency between regulatory registration documents and the actual operations of our plants through annual product quality reviews. If any inconsistency is found, we will immediately notify the marketing authorization holder and discuss the next course of action. Also, this fact should be notified to our senior management.

Senior management reviews the control of responsible officers of each plant twice a year in regard to compliance with pharmaceutical laws and regulations.
We establish a quality manual that describes senior management involvement, responsibility, and organization to ensure a pharmaceutical quality system. It also stipulates our compliance system, which is based on the “Guidelines on Compliance of Law for Marketing Authorization Holders and Manufacturers“.