EN – GMP Meister® Academy

2025-02-05 ｜記事

How to Respond to a PMDA Inspection: Mechanism by which the observation is issued

The characteristics of PMDA inspectors are as stated in the previous blog—For an Effective Inspection Response […]

2025-01-30 ｜記事

How to Respond to a PMDA Inspection: For an Effective Inspection Response

Pharma Planning Co., Ltd. (hereinafter PP) conducts gap analysis and provides guidance on PMDA GMP/GCTP inspec […]

2025-01-17 ｜記事

Current Regulatory Status of Regenerative Medicine and GMP/GCTP in Japan

For regenerative medicine, the applicable legal regulations differ based on whether the products are distribut […]

2025-01-14 ｜記事

Regulations related to GMP in Japan – Tets Takarada

Pharmaceutical products intended for the Japanese market shall comply with the Pharmaceuticals and Medical Dev […]

2025-01-14 ｜記事

Release of the revised version of the Q&A for ICH Q8/Q9/Q10 – Tets Takarada

The Q&A for Q8/Q9/Q10 was created by the ICH Q-IWG and was issued in 2009. It was revised as R5 on October […]