Yasuhito Ikematsu Chair of Aseptic Product GMP Committee, Japan PDA Pharmaceutical Society

Yasuhito Ikematsu is an associate professor at the Graduate School of Engineering, Osaka University, and concurrently serves as director of the Osaka University Cell Manufacturing Simulation Engineering (Hitachi) Joint Research Chair. For more than 15 years at PDA Japan chapter, Ikematsu has been engaged in research on sterility and quality control in sterile pharmaceuticals and ATMPs, as well as research and dissemination of rapid microbial testing methods. Ikematsu also contributes to regulations and guidelines in Japan, conducting regulatory science and human resource development.

Ikematsu is also actively involved in quality control in pharmaceutical manufacturing in accordance with Good Manufacturing Practice (GMP), promoting the practical implementation and appropriate application of PIC/S GMP Guide Annexes 1 and 2A. Through his collaboration with the PDA headquarters and regional chapters, Ikematsu shares information with members involved in developing of USP and EP standards. This contributes to achieving international harmonization among the three major pharmacopoeias (JP, USP, and EP). Ikematsu notably serves as Chair of the Standards Committee for the new “Training System for Visual Inspection Supervisors and Inspectors for Visible Particulates in Injectable Products,” which is set to launch in 2025 by PDA Japan. In this role, Ikematsu addresses various key quality control issues and drives a wide range of research and implementation efforts, focusing on sterility.