FY 2026 (53rd) GMP Roundtable Meeting Future Strategies for the Pharmaceutical Industry — Integration of Quality, Regulatory Affairs, and Technological Innovation — Sustainable Quality Assurance Achieved Through Trust Fostered by Learning and Compliance with Regulations —

The FY2026 (53rd) GMP Roundtable was held in person on Friday, June 26, at the Nihonbashi Life Science Building.The theme for this session was “Future Strategies for the Pharmaceutical Industry — The Convergence of Quality, Regulatory Compliance, and Technological Transformation — Sustainable Quality Assurance Achieved Through Trust Forged by Learning and Compliance with Regulatory Frameworks —,” and 32 member companies of the Quality & Technology Committee participated.

Speakers of case studies and members of the JPMA GMP Subcommittee

Due to recent advances in digital technology, the pharmaceutical manufacturing sector is undergoing a period of significant transformation. While the use of digital technologies, including AI, is driving the streamlining of manufacturing processes and the advancement of quality control, pharmaceutical companies are also being called upon to take on new initiatives that contribute to ensuring quality and maintaining trust.

In light of these circumstances, this year’s GMP Roundtable focused on collaboration between marketing authorization holders and manufacturers to enhance personnel development and educational systems aimed at ensuring quality with patients as the top priority. Discussions also centered on each company’s initiatives regarding laws, ministerial ordinances, guidelines,Pharmacopoeia, which significantly impact the stable supply of pharmaceuticals, as well as responses to GMP compliance inspections—with a focus on each company’s specific initiatives. Furthermore, by sharing each company’s innovative approaches, the meeting provided an opportunity to reexamine daily quality assurance practices aimed at delivering high-quality pharmaceuticals to patients in a stable manner.

Furthermore, during the open discussion session, topics that had garnered significant interest in the pre-event survey—such as “digitization of records,” “GMP-GQP coordination,” “manufacturer management,” “discrepancies in approval documents,” and “DX”—were addressed. Participants were divided into groups based on their preferences, providing opportunities for highly specialized discussions.

High-quality discussions took place among the participants, and many best practices were shared. Although participants appeared somewhat nervous at the start, the atmosphere gradually became lively, with active and candid comments and questions exchanged, leading to a very engaging session.Following the GMP Roundtable, a networking session—which had been well-received at the previous event—was held, allowing participants to continue their discussions and build professional connections. We hope this roundtable will serve as a valuable resource for participants as they advance their quality assurance efforts.

We plan to compile the proceedings into a summary booklet and distribute it as a PDF around November of this year to serve as a resource for professional development at member companies.

Scene from the GMP Roundtable venue

Members of the GMP Subcommittee of the JPMA Quality & Technology Committee (Organizers)

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