Topics Holding of "FY 2022 (49th) GMP Case Study Workshop
As part of its business activities in fiscal year 2022, the Pharmaceutical Manufacturers Association of Japan (PMAJ) Quality Committee held the "FY2022 (49th) GMP Case Study Workshop" on September 9, 2022 under the theme of "Global Response to Pharmaceutical Quality Assurance and New Developments in Manufacturer Management" in cooperation with the Japan Pharmaceutical Information Center (JAPIC). From the perspective of preventing the spread of new coronavirus infection (COVID-19), the seminar was held in a fully online seminar format as in 2021. The seminar was a success with approximately 800 participants.
Speakers of case study presentations and members of the day's management (GMP Subcommittee of the Pharmaceutical Manufacturers Association of Japan)
The outbreak of the novel coronavirus infection (COVID-19) has not ended, and all social activities are still restricted, but pharmaceutical companies have a mission to ensure a stable supply of high-quality pharmaceutical products.
On the other hand, the stable supply of pharmaceuticals has been greatly affected by administrative actions and product recalls in the past few years in response to misconduct by some pharmaceutical companies, and the industry as a whole is working on improvements to restore the trust of society. In April 2022, the government issued a "Notice on Quality Control by Manufacturers, Distributors, and Manufacturers in Light of Incidents of Pharmaceutical Quality Problems (2022)", following the "Notice of the Director of the Monitoring, Guidance, and Narcotics Control Division, Pharmaceuticals and Consumer Health Bureau, Ministry of Health, Labour and Welfare, No. 1211-1, December 11, 2020, on the appropriate manufacturing control of pharmaceutical products". (April 28, 2022, Ministry of Health, Labour and Welfare, Pharmaceuticals and Welfare Bureau, Surveillance, Guidance and Narcotics Control Division, Director's Notification)" was issued in April 2022, and the quality assurance of pharmaceutical products through cooperation between manufacturers and distributors is required.
The GMP Case Study Workshop in FY2022 was held with the following program ( Table 1). Mr. Hiroki Kato of the Pharmaceutical Quality Control Department of the Pharmaceuticals and Medical Devices Agency (PMDA) gave a special lecture entitled "The Revised GMP Ministerial Ordinance - Focusing on Recent Guidance Cases -" in which he introduced the outline of the revised GMP Ministerial Ordinance and PMDA's efforts to address quality issues, etc. with explanations. He also gave an overview of the revised GMP ordinance and the PMDA's efforts to address quality issues. In the case study presentations section, three presentations were made by member companies of the Pharmaceutical Manufacturers Association of Japan (PMAJ) on topics related to this year's theme, such as the global response of quality assurance systems, and case studies of manufacturer audits by marketing authorization holders. Each presentation provided detailed explanations of each company's experiences and innovations, and participants asked more than 40 questions online, with answers to the most representative questions provided after the presentations.
Pharmaceuticals and Medical Devices Agency
Pharmaceuticals and Medical Devices Agency
Mr. Hiroki Kato, Drug Quality Control Department, Pharmaceuticals and Medical Devices Agency (PMDA)
Table 1 Program
The special lectures and case studies presented at this year's conference were very meaningful for improving the level of quality assurance at each company. In addition to actively disseminating information through GMP Case Study Meetings, GMP Roundtable Meetings, and the Pharmaceutical Quality Forum, the Pharmaceutical Quality Committee of the Pharmaceutical Manufacturers Association of Japan (PMAJ) will provide more practical topics to contribute to the further development of the pharmaceutical industry. In cooperation with the government and other organizations, we will support the internationalization and upgrading of quality assurance systems.
( Naohide Hori, GMP Case Study Group Project, Quality Committee)