PMDA-ATC GMP Inspection Seminar 2024
The PMDA-ATC GMP Inspection Seminar 2024 was held from October 8 to 10 at the manufacturing plant of Kyowa Pharma Chemical. Co., Ltd. (the plant) in Toyama prefecture. This training seminar was supported by the Pharmaceutical Inspection Co-operation Scheme (PIC/S). A total of 15 GMP inspectors participated from Chinese Taipei, Hong Kong SAR China, India, Indonesia, Malaysia, the Philippines, Sri Lanka, and Thailand.
The seminar opened with the remarks by Dr. KONDO Emiko, Senior Executive Director of PMDA, Director of the Asia Training Center, followed by the video message from Mr. BOON Meow Hoe, the PIC/S EB member-cum-Chair of PIC/S Subcommittee on Training of Inspectors, Ms. ISHIDA Miki, Director, Pharmaceutical Business Promotion Division, Health and Welfare Department of Toyama Prefectural Government, and Mr. MIYOSHI Hayato, CEO, Representative Director and President of Kyowa pharma chemical Co.,Ltd.
This training seminar served as a mock inspection, and the training program was followed by an actual Japanese GMP inspection. On the first day, after lectures on GMP regulations in Japan, the point of inspection of drug substance manufacturing, and an overview of manufacturing plants and products, participants were divided into three groups to discuss inspection planning. On the second day, each group visited the manufacturing and analysis rooms, and made inquiries at each site. On the third day, a document-based inspection was conducted, focusing on the points found during the plant tour. Finally, the results from three days of inspection were summarized and presented by each group. The lecturers comprised three staff members from the PMDA, one employee from the Toyama Prefectural Government, and one employee from Kyowa Pharma Chemical Co., Ltd.
(See the program for details[169KB])
This event was closed with the remark by Dr. KONDO Emiko, followed by Mr. IWASE Ryo, Director, Pharmaceutical Administration Division, Health and Welfare Department of Toyama Prefectural Government. As a token of active participation in the seminar, the digital certification of Open Badge was given to the participants.
Photos and participant comments
Comments from the participants:
"The mock inspection was a good experience in API manufacturing inspection. "
" We know the high standards of API GMP Compliance in Japan. Hope we can share and apply it to our country."
"It was highly insightful and practical. Interactive discussions and case studies were especially helpful to enhance my skills."
"Well organized, concise seminar, two-way communication."
