Last summer, the Japanese MHLW issued guidelines saying the PMDA and the prefectural authorities should do surprise GMP inspections on factories that have had many previous problems. The surprise GMP inspections were to stop factories from covering up sensitive issues before inspections. Last month, the PMDA increased such oversight and said such high-risk factories must have surprise GMP audits at least once per year starting April 1, 2022. New penalties will be issued for factories that fail to implement changes requested at previous inspections, fix problems in recent recalls, and fulfill other PMDA requests.
Written by: Ames Gross – President and Founder, Pacific Bridge Medical (PBM)
Mr. Gross founded PBM in 1988 and has helped hundreds of medical companies with regulatory and business development issues in Asia. He is recognized nationally and internationally as a leader in the Asian medical markets. Mr. Gross has a BA degree, Phi Beta Kappa, from the University of Pennsylvania and an MBA from Columbia University.
Source used in the article:https://www.pmda.go.jp/english/review-services/gmp-qms-gctp/0003.html