“Laboratory of Pharmaceutical Quality Design and GMP”
The social collaboration course, “Laboratory of Pharmaceutical Quality Design and GMP” was established in July 2020 for the purpose of contributing to: 1) the distribution of high-quality pharmaceuticals, 2) the efficient application of innovative production technologies, and 3) the proper and efficient implementation of quality-related regulations, which aim to support enhancement of the industry-government-academia collaboration through education and research activities related to pharmaceutical quality and GMP.
In the midst of remarkable progress in science and technology, we set the laboratory’s task as how to proceed with the quality assurance of pharmaceuticals and regenerative medicine products including new modalities, to harmonize regulations (regulatory science) through research on global standards and guidelines, and to connect the latest knowledge obtained from the above to human resource development.
Front row from left : Saeko Takamatsu**, Professor Shingo Sakurai, Masaji Suzuki*, Reiko Mukohara**
Back row from left : Shinichiro Mohri**, Hitoshi Takayashiki**, Kayo Migita***, Eriko Komori***, Noboru Aoki**
Jan./2024
Front row from left : Professor Shingo Sakurai, Masaji Suzuki*
Back row from left : Hitoshi Takayashiki**, Saeko Takamatsu**, Reiko Mukohara**, Masatoshi Takemata**
Oct./2023
* : Project Fellow ** : Expert *** : Assistant
GMP Education and Training Course
Appropriate GMP human resource development is essential toward the activation and soundness of the domestic pharmaceutical industry. To meet this challenge, Faculty of Pharmaceutical Sciences, Tokyo University of Science has established “GMP Education and Training Course”, which provides a systematic education on GMP for the first time in Japan, in reference to the reasonable framework of EU used in the QP system, “Qualified Person (QP) Training and Qualification Course”.
Currently in Japan, the pharmacist license is required to be a security pharmacist, whereas GMP education is not incorporated into pharmaceutical education. Under these circumstances, the role of this course is considered extremely important. We hope that those who have completed this course will apply appropriate GMP in their respective sites, leading to the manufacture of high-quality pharmaceutical products.