Topics Held the 50th GMP Case Study Workshop in 2023
The Pharmaceutical Manufacturers Association of Japan (PMAJ) Quality Committee held the "FY2023 (50th) GMP Case Study Workshop" with the Japan Pharmaceutical Information Center (JAPIC) on September 8, 2023, under the theme of "Interbusiness Cooperation and Assurance of Pharmaceutical Quality and Reliability in a Global Environment" as part of its FY2023 business activities. As in 2022, the conference was held in an online seminar format instead of at the venue. The seminar was a success with approximately 700 participants.
Speakers of case study presentations and members of the day's management (GMP Subcommittee of the Quality Committee of the Pharmaceutical Manufacturers Association of Japan)
In recent years, the Japanese pharmaceutical industry has been required to solve various issues, such as stable supply of pharmaceuticals, management of manufacturing sites, utilization of digital technology, creation of new modality products, and entry into the global market. In April 2022, the Ministry of Health, Labour and Welfare issued a "Notice of the Director of the Monitoring, Guidance and Narcotics Control Division of the Pharmaceuticals and Medical Supplies Bureau, Ministry of Health, Labour and Welfare, No. 0428 No. 2 (April 28, 2022)," which requires manufacturers and distributors to work together to ensure the quality of pharmaceutical products.
The GMP Case Study Workshop in FY2023 was held with the following program (Table 1). As a special lecture, Mr. Shiro Kawahara of the Pharmaceutical Quality Control Department of the Pharmaceuticals and Medical Devices Agency (PMDA) gave a presentation titled "PMDA's Efforts and Recent Guidance Cases Concerning Quality Assurance," introducing PMDA's efforts, including future plans, focusing on risk communication promotion and PR activities. He also introduced PMDA's initiatives, including its future plans, with a focus on risk communication promotion and public relations activities. In the case study presentations section, three presentations were made by member companies of the Pharmaceutical Manufacturers Association of Japan (PMDA) on topics related to the FY2023 theme, including English-language education in QA work, proper management of master files (MF), and global response to quality assurance systems. Each presentation provided detailed explanations of each company's experiences and innovations, and participants asked more than 70 questions online, with the most representative questions being answered after the presentations.
Pharmaceuticals and Medical Devices Agency
Drug Quality Control Department, Pharmaceuticals and Medical Devices Agency
Table 1 Introduction of each presentation
We hope that the presentations and case studies will be very meaningful for the improvement of quality assurance level of each company and will be useful for your future reference. We will contribute to further development of the pharmaceutical industry by providing more practical topics in addition to active information dissemination through GMP Case Study Meeting, GMP Round Table Meeting, Pharmaceutical Quality Forum, etc. in accordance with our business activity policy. We will continue to support the internationalization and upgrading of quality assurance systems in cooperation with the government and other organizations.
( Eri Iwasaki, GMP Case Study Project, GMP Subcommittee, Quality Committee)