2022 Volume 24 Issue 2 Pages 23-31
There have been frequent problems related to illegal manufacturing of pharmaceuticals in Japan. One of the causes of these illegal manufacturing problems is insufficient sharing and utilization of knowledge throughout the product lifecycle. In addition, the revised GMP Ministerial Ordinance came into force in 2021, requiring pharmaceutical manufacturers to effectively establish and implement a “pharmaceutical quality system (PQS).” Knowledge management, one of PQS's “enablers”, is said to be a fundamental concept that should be utilized in implementing PQS. It is useful to understand ‘knowledge management’ as it applies throughout the product lifecycle. Based on this background, a questionnaire survey was conducted with the aim of grasping the current state of knowledge management in domestic pharmaceutical companies and clarifying the issues.
From the 395 responses obtained through the survey, it became clear that while the understanding of the concept and purpose of knowledge management itself is progressing, there are problems in the practical methods of knowledge management. There are also issues with sharing knowledge during technology transfer, and it was speculated that these may be related to the recent illegal manufacturing problem.
Each company is required to use effective knowledge management to practice the revised GMP ministerial ordinance and to solve the problem of illegal manufacturing. For that purpose, it is necessary to establish a system to increase knowledge from the individual level to the organizational level and a communication process for sharing knowledge between departments.
