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Report of the PMDA-ATC GMP Inspection Seminar 2016

PMDA-ATC GMP Inspection Seminar 2016

Pharmaceuticals and Medical Devices Agency (PMDA) recently completed the PMDA-Asia Training Center for Pharmaceuticals and Medical Devices Regulatory Affairs (ATC) Good Manufacturing Practice (GMP) Inspection Seminar 2016 on December 5-9, 2016, with the support of Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (PIC/S). The seminar was held at Toyama prefecture in Japan, as a project of PMDA Hokuriku Branch. The seminar was designed for GMP inspectors from overseas regulatory agencies. Total of 19 inspectors from 12 countries/regions (Brazil, Hong Kong, Kazakhstan, Latvia, Malaysia, Mexico, Myanmar, Philippines, Singapore, Slovenia, Taiwan and Thailand) joined the seminar.
The seminar opened with welcome speech by Mr. Haruo Akagawa, Director of PMDA-ATC, followed by lectures by PMDA staff members and overseas PIC/S instructors. From the second day, the seminar took place at an actual manufacturing site recommended by Japan Pharmaceutical Manufacturers Association (JPMA), where introduction on the manufacturing site and on-site training program were provided. The topics discussed included the latest information of PIC/S, potential risk for the manufacturing solid dosage form, the basic manner of inspection, risk-based inspection and the data integrity considerations for electronic-based systems (see agenda for details). In addition to lectures, group discussions and a mock inspection were conducted with facilitators from PMDA and the manufacturing site. The participants actively and enthusiastically engaged in discussions throughout the seminar.
In total, more than 10 staff members from PMDA contributed to the lectures and group works.
At the end of the seminar, the course completion certificates were awarded to each participant by Dr. Shingou Sakurai, International Senior Training Coordinator as well as Office Director of Office of Manufacturing/Quality and Compliance.

Photos and participant comments

<Lectures by PMDA staff members>
Lectures were provided by experts in GMP inspection. Participants enthusiastically asked many questions.

GMP Inspection 2016
Comments from participants:

"The presentation has provided a good overview on PIC/S background information, functions, and advantages of being a member agency. The presentation was delivered in a lively way and engaged audiences easily."

"The importance of evaluate GMP according to a risk management assessment as an inspector is a tool that gives us a better understanding of the company. In this presentation we learned how to evaluate and focus our efforts in a good inspection plan with the information provided in the site master file and the report of previous inspections."

"It’s very informative presentation on the topic of data integrity. Able to have an idea on data integrity, use of electronic system in the modern industry practices and supply chain. Able to gain some insights on what are the areas to focus on when it comes to inspection related to data integrity."

<Group work session>
Group work sessions are one of the key sessions of the seminar. The group works provided opportunities where the participants discussed with other inspectors as well as staff members on the important points to be kept in mind while conducting GMP inspections.

Comments from participants:
"Very good cooperation from every member of the group. The process of planning was very good. The facilitator and the information given was very useful for quality risk management analysis and inspection plan."

"The site tour helped a lot for introducing advanced technology and techniques for manufacturing solid dosage forms. The personnel were able to give points on why things are done in the site."

"The representatives from company, facilities & translators were all very helpful to keep answering the questions. In the morning, we had summarized the list of standard operation procedures to be inspected & then reviewed in the afternoon. The arrangement made our inspection process very efficient."

Overall comments from the participants

"It is a very pleasant seminar to me personally. The organizer, the PMDA staff, really did a great job in arranging everything for the participants, from the logistics, accommodation, training content and hospitality. Everything that is arranged & provided by or find from PMDA is really top-of-the-class! Thank you very much."
"The best training for inspectors I have ever attended. I wish inspectorates would organize such training for each type of manufacturing."
"Very well organized seminar. I will definitely suggest my colleagues to attend this seminar."

PMDA-ATC Seminars are held periodically, with a different theme for each seminar.
The Seminar announcements are posted on this website.
For any questions regarding PMDA Training Seminar, please contact us by clicking on the "Contact us" logo on top of the website, or please contact the Secretariat, PMDA-ATC@pmda.go.jp

JCN 3010005007409

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Chiyoda-ku, Tokyo 100-0013 Japan

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