We have posted the event report for the “FY 2026 (53rd) GMP Case Study Seminar.”
As part of its FY2026 business activities, the JPMA Quality & Technology Committee organized the “FY2026(53rd) GMP Case Study Seminar” on September 25, 2026, under the theme “Integration of On-Site Capabilities, Equipment Reliability, and Digital Utilization to Enhance the Effectiveness of Quality Assurance,” in collaboration with the Japan Pharmaceutical Information Center (JAPIC), a general incorporated foundation. Held once again this year as an online seminar, the event welcomed approximately 600 participants and concluded successfully.
Presenters and event staff (GMP Subcommittee of the JPMA Quality & Technology Committee)
In recent years, the environment surrounding the pharmaceutical industry has undergone significant changes, and numerous challenges have emerged in both regulatory and operational aspects—including strengthening stable supply systems, preventing the recurrence of quality nonconformities, ensuring data integrity (DI), and building trust in contract manufacturing.Under these circumstances, marketing authorization holders and manufacturers are required to establish more advanced and effective risk-based quality assurance systems.
This year, as a special lecture, Ms. Mizuki Hiiizumi of the First Quality Control Division, Pharmaceutical Quality Control Department, at the Pharmaceuticals and Medical Devices Agency (PMDA),“Recent Topics on GMP—PMDA’s Initiatives Regarding the Revision of the Pharmaceutical and Medical Device Act and Quality Assurance,” in which she introduced trends in the revision of the Pharmaceutical and Medical Device Act and PMDA’s initiatives related to quality assurance.In addition, during the case study session—made possible through the cooperation of JPMA member companies—three presentations were given in relation to this year’s theme: a case study on equipment malfunctions at a biopharmaceutical plant; efforts to standardize quality through the automation of device visual inspections; and an overview of the activities of the Quality Culture Project within the JPMA’s GMP Subcommittee —Sharing “Quality Culture” (a mindset toward quality) and strengthening contractor-client relationships centered on psychological safety—. Each presentation provided detailed explanations of the companies’ experiences and innovative approaches, and participants posed several questions online; representative questions were answered following the presentations.
Special Lecture
1. Recent Topics Regarding GMP—Revisions to the Pharmaceutical and Medical Device Act and PMDA Initiatives for Quality Assurance
, Quality Control Division 1, Department of Drug Quality Control, Pharmaceuticals and Medical Devices Agency (PMDA)
Ms. Mizuki Hiiizumi
In light of the amendments to the Pharmaceutical and Medical Device Act enacted in 2025, there is a growing need to strengthen quality assurance and stable supply systems. In this presentation, the speaker provided an overview of the amendments to the Pharmaceutical and Medical Device Act and provided an explanation of PMDA’s initiatives regarding quality assurance as part of recent topics related to GMP.
Case Study Presentation
1. Case Study: Equipment Malfunctions at a Biopharmaceutical Manufacturing Facility
DAIICHI SANKYO CO., LTD., Technology Division, Technology Development Department, Engineering Technology Research Laboratory
Mr. Yoshitomo Sugiura
A case study of equipment failures that occurred at DAIICHI SANKYO CO., LTD.’s biopharmaceutical plant was presented. This presentation explained the circumstances surrounding the failures, the response measures taken, and initiatives to ensure equipment reliability, using actual case examples.
2. Achieving Consistent Quality Through the Challenge of Automating Device Visual Inspection
Eli Lilly Japan K.K., Manufacturing Division
Mr. Motoi Inamoto
This presentation introduced the challenges faced by Eli Lilly Japan K.K. in automating device visual inspections. The speaker explained the company’s efforts to achieve consistent quality through the automation of visual inspections, including the strategies employed during implementation and the challenges encountered.
3. Introduction to Activities of the Quality Culture Project in the GMP Subcommittee of the JPMA—Strengthening Client-Contractor Relationships Centered on Sharing a “Quality Culture” (Approach to Quality) and Psychological Safety—
CHUGAI PHARMACEUTICAL CO., LTD. Quality Assurance Department, Reliability Assurance Unit,
Mr. Tadashi Tsukazaki
As part of the activities of the Quality Culture Project under the GMP Subcommittee of the JPMA Quality & Technology Committee, initiatives aimed at sharing “Quality Culture” (a mindset toward quality) and strengthening contractor-client relationships centered on psychological safety were introduced. This presentation explained the project’s activities designed to promote mutual understanding between the contracting and contracted parties.
We hope that this special lecture and the case study presentations will prove highly valuable for improving quality assurance standards at each company and serve as a useful reference for future efforts.