PMDA-ATC GMP Inspection Webinar 2024
On February 6 and 7, PMDA held a webinar entitled “PMDA-ATC GMP Inspection Webinar 2024“ with the support of Pharmaceutical Inspection Co-operation Scheme (PIC/S). This webinar was intended for officials of overseas regulatory agencies involved in the GMP Inspection. A total of 30 regulators from Azerbaijan, Bangladesh, China, Chinese Taipei, India, Indonesia, Kazakhstan, Malaysia, Pakistan, Philippines, Sierra Leone, Singapore, South Korea, Sri Lanka, Tunisia, and Uganda participated.
The workshop opened with the remarks by Dr. UZU Shinobu, Senior Executive Director of PMDA and Director of PMDA-ATC, followed by Mr. ENO Hideo, Senior Coordinator for International Training.
On the first day, the lectures on Japan GMP regulation were provided. Then participants shared GMP inspection system in each country or region and use of foreign authorities’ GMP inspection results.
On the second day, the lectures on the efforts of PMDA and industry for quality-related issues were provided. The case studies were followed using “ORANGE Letter” which describes actual inspectional observations.
PMDA staff members and a lecturer from industry as lecturers and facilitators. (see the program for details[219.12KB])
This event was closed with the remark by Dr. UZU Shinobu. As a token of active participation in the workshop, the digital certification of Open Badge was given to the participants.
Photos and participant comments
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Comments from the participants:
“The webinar was a good refresher in GMP and also showed how Japan has mastered GMP and how to master pharmaceutical quality issues.”
“Good material especially on the ORANGE Letter”
“This webinar was very productive and provided up-to-date knowledge and fulfilled my expectations about GMP Inspection.”
“The entire training is well place especially for developing countries to understand key areas to be focus on during GMP inspection especially when most products are imported into our countries and identification of process that have the potential of risk in drug production in most manufacturing facility.”