Drug Evaluation Committee QMS in PV
Pharmacovigilance Subcommittee
January 2026
The introduction of a Quality Management System (QMS) and the implementation of a quality cycle in each pharmaceutical company will contribute to improving the quality of PV operations by enabling them to recognize problems on their own and autonomously formulate and implement solutions.
KT-7 gave a lecture titled "QMS in PV" on March 5, 2025 at the RS Foundation Expert Training "Establishment and Practice of PV System of International Standard Based on Global PV Regulations in FY2024" on the overview of QMS and its importance.
We have prepared an Explanation of QMS in PV based on the lecture material so that more people can deepen their understanding of QMS.
We hope that this document will help promote understanding of QMS in pharmaceutical companies and further improve the quality of PV operations.
Drug Evaluation Committee, Japan Pharmaceutical Manufacturers Association
Pharmacovigilance Subcommittee, Continuing Issues Team 7 (KT-7)