MHLW / PMDA / USP Workshop presentations

Naiffer_Host · July 30, 2021, 6:24pm

Last June 16-17 MHLW/PMDA and USP hosted workshop ‘Role of Quality in Pharmaceuticals’.
We had a dedicated track on Mutagenic Impurities including Nitrosamines.

Dr. Kazusei Komatsu from Shionogi presented the current situation and case study of ICH M7 at a Japanese Company - https://www.pmda.go.jp/files/000241926.pdf
Dr. Yasuo Hirai from Daito Pharmaceutical presented current comprehensive approach for control of Nitrosamine Impurities in Japan - https://www.pmda.go.jp/files/000241927.pdf
Dr. JuJunichi Fukuchi from PMDA introduced control of organic impurities in marketed products in Japan - Current status and perspectives - https://www.pmda.go.jp/files/000241928.pdf
Dr. Masahiro Uchino from PMDA presented a case study on the control of Nitrosamine impurities in Sartan drugs - https://www.pmda.go.jp/files/000241930.pdf

Any particular interest of our community in hosting PMDA for a candid discussion. What would be you ask (other than when is the guide coming out)?

Yosukemino · July 31, 2021, 3:14pm

Thank you for sharing, @Naiffer_Host. This was a very impressive workshop. I want others to see second slides presented by Dr. Hirai, he really made a lot of efforts to meet requirements. I guess many participants can take a better way, but it’s his real. It looks so tough. And I want to clarify lots of challenges concerning with nitrosamine impurities and reduce workloads of pharmaceutical companies and others as far as I can.