PMDA Asia office GMP Workshop Training 2026
PMDA Asia office GMP Workshop Training 2026 was organized on March 17, 2026. Designed for strengthening GMP inspection skills, it was attended by 12 GMP inspectors from Malaysia, Thailand, and the Philippines. This workshop is the first training held by the PMDA Asia office.
The workshop aims to build basic knowledge on specific events encountered in routine GMP inspections and develop the ability to provide practical guidance for improvement - areas that fall outside the scope of PIC/S training and PMDA ATC GMP Seminars, both of which deal with the latest technical topics. The workshop is designed for a three-year program with fixed members.
The workshop opened with welcome remarks from Dr. KITAHARA Jun, Head of PMDA Asia office.
The program started with the basic concept of training for the GMP Inspectors, followed by lectures on control strategies of cross-contamination in shared facilities and inspection of sterile products (Implementation of PIC/S GMP Annex 1). Participants also conducted on case studies and shared their opinions on stability monitoring and change control during discussions. To wrap up the workshop, participants shared their 6-months and 12-month goals, discussed potential initiatives to drive forward through the workshop, and explored the future evolution of this cooaboration.
Comments from participants:
- This kind of opportunity is hard to get and difficult to gather the regulators from different country especially Dr Hara which travel all the way from Japan. We should take full advantage of this valuable opportunity.
- The group discussions allowed us to see how different inspectors approach the same GMP challenges, which was highly educational.
- The small number of participants allowed for better focus and more effective discussions. However, it would be even more beneficial if the workshop could be arranged over two days with slightly shorter daily sessions.
