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.

Through this paper, we aimed to describe the new concept of reducing carbon dioxide (CO₂) emissions from aseptic processing equipment as well as the concept and prospects of a non-thermal sterilization system (called GREEN ASEPTIC) combining medium-pressure (MP) ultraviolet lamps and filtration sterilization. Considering that filterable bacteria can pass through a sterile filter with a pore size of 0.2 μm, filtration sterilization has not been adopted in aseptic polyethylene terephthalate (PET) bottle filling systems for low-acid beverages. Therefore, we examined the ultraviolet (UV) sensitivity of twelve types of filterable bacteria and Bacillus atrophaeus spores via bench-scale collimated beam testing. The results showed that the UV resistance of the filterable microbes was about half or less that of B. atrophaeus spores. Additionally, the UV light emitted via MP lamps was more effective for the disinfection of these bacteria under our experimental conditions than low-pressure (LP) lamps. The sterilization effect on B. atrophaeus spores was also verified at 80 mJ/cm² with Atlantium's MP lamps. The addition of 1×10⁷ colony-forming units of B. atrophaeus spores to pure water at a flow rate of 18 m³/h killed all the spores, with a more than 7-log reduction value.

These results suggest that the combination of MP lamps and filtration sterilization can produce sterile liquids of the same quality as those produced by ultra-high- temperature (UHT) sterilizers and can be expected to significantly reduce CO₂ emissions from aseptic processing equipment.

This article describes progress of revision work of the ICH Q9 (Quality Risk Management: QRM) guideline and training materials. The first version of the ICH Q9 guideline reached Step 5 in September 2006 and has been in use in various countries for over 15 years. In the revision work, feedback from experiences after QRM implementation up to now, and ideas of ICH Q10, Q12, Q14, etc. will be reflected to promote commonality of QRM concepts among regulations and industries, and additional training will be provided.

The author has been involved in the management of PIC/S since January 2022 as Executive Bureau Member. The current status of global harmonization of GMP standards, the challenges facing PIC/S and the significance of participating in PIC/S activities are described in this review article with the author's personal views. PMDA, Ministry of Health, Labour and Welfare (MHLW) and 47 prefectures of Japan became PIC/S' Participating Authority in 2014. To ensure the quality of medicines distributed on the global market, PIC/S including the PMDA should try to develop more effective GMP regulations.