To Improve Pharmaceutical GMP Inspections, Japan’s MHLW will Develop a New Inspection Manual

Due to manufacturing problems with some generic products, the MHLW will now bolster GMP via issuing a new inspection manual. This inspection manual will apply to both generic and new drugs. Representatives from various pharmaceutical associations, the PMDA, and others have now set up a task force to study and write up a new inspection manual. The manual will not be a simple checklist but rather an extensive document outlining why inspections are required and priority items to be checked. The manual can be used by representatives of drug facilities to be inspected and inspectors. Hopefully, the inspection manual will make the public feel better after several drug scandals. It is expected to be issued and implemented by March 2023.

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.