This message was posted by a user wishing to remain anonymous
This is great news, and much needed.
Given the input from multiple sources, can we expect issuance in English as well as Japanese?
And if anyone has free resources for Japan's regulatory guidance and regulations translated into English I would appreciate having the reference.
Original Message:
Sent: 18-Jul-2022 16:08
From: Ames Gross
Subject: To Improve Drug 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.
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Ames Gross
President
Pacific Bridge Medical
Bethesda, MD
www.pacificbridgemedical.com
contact@pacificbridgemedical.com
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