Pharma Planning Co., Ltd. (hereinafter PP) conducts gap analysis and provides guidance on PMDA GMP/GCTP inspection responses for domestic and international manufacturing sites.
How do the quality and characteristics of PMDA inspectors compare to those in other regions? Having experienced being a PMDA senior inspector myself, I believe that, overall, the quality and perspective of the questions are not significantly different from those of the FDA. Since the establishment of PMDA in 2004, retired industry professionals have been appointed as senior inspectors to educate the younger generation, which is likely a contributing factor. However, due to their backgrounds, there is variability in their inspection capabilities, and it cannot be denied that some inspectors have provided guidance to manufacturing sites without sufficient regulatory knowledge.
Until about four or five years ago, it was common for inspections to be conducted by a pair consisting of an older inspector (contract employee and senior inspector) and a younger inspector (regular employee), with the regular employee serving as the leader. However, in recent years, the system has undergone reforms, and as younger employees have grown, they have started to take on roles as senior inspectors. I also have the impression that their capabilities have improved.
Compared to general trends in other regions, a distinctive characteristic of PMDA is that they consistently emphasize throughout the inspection period their desire for thorough discussions to avoid any misunderstandings. However, based on my experience with PMDA, I have the impression that manufacturing sites are still somewhat reserved. In general, inspectors lack verbal communication skills in English, so the manufacturing site is responsible for hiring an interpreter. Often, these interpreters are not specialists in the field, which frequently leads to communication issues. One of the key factors in successfully completing an inspection is hiring a competent interpreter(s).
PP provides consulting services for PMDA inspection (GMP or GCTP) responses, offering effective and efficient proposals by considering the characteristics of inspectors and the unique aspects of Japanese regulations. That audit approach, based on my experience with PMDA inspections, can be conducted using any method—on-site, desktop, or remote. If you are interested, we recommend visiting the PP website for consultation.
In future blog posts, if the opportunity arises, I would like to provide additional insights into the characteristics of PMDA inspections.
PP official website: https://www.pharma-planning.com/en/
