Holding of "The 52nd GMP Case Study Workshop in FY 2025 Strengthening Quality Assurance Implementation Capability and Site-Driven Problem Solving Approach
As part of its activities in fiscal year 2025, the Pharmaceutical Manufacturers Association of Japan (PMAJ) Quality Committee held the "52nd GMP Case Study Workshop in FY 2025" on September 12, 2012, under the theme of "Strengthening Quality Assurance Implementation Capability and Site-Driven Problem Solving Approach" in cooperation with the Japan Medical Information Center. This year's event was again held in the form of an online seminar, and was a success with approximately 660 participants.
Speakers of case study presentations and members of the day's management (GMP Subcommittee of the Pharmaceutical Manufacturers Association of Japan)
In recent years, the pharmaceutical industry has been facing a number of challenges in terms of both institutional and practical issues, such as eliminating drug lag and drug loss, strengthening stable supply systems, preventing recurrence of quality irregularities, ensuring data integrity (DI), and building reliability in contract manufacturing. In addition, the effectiveness of the quality assurance system required of distributors and manufacturers is being questioned more strictly than ever in the wake of scandals at some manufacturers.
This year, Mr. Ryusei Ishii of the Pharmaceutical Quality Control Department of the Pharmaceuticals and Medical Devices Agency (PMDA) gave a special lecture titled "PMDA's Efforts to Ensure Quality and Recent Guidance Cases," introducing recent guidance cases and PMDA's risk communication promotion and public relations activities, including future plans. He also introduced PMDA's plans for the future. In the case study presentation section, pharmaceutical association member companies cooperated in presenting case studies related to this year's theme, including the in-house manufacturing of drug formulation processes by reusing existing buildings, efforts to implement a data governance system to strengthen DI, and an introduction of the activities of the Quality Culture Project of the GMP Subcommittee of the Pharmaceutical Manufacturers Association of Japan (PMAJ) - Building Mutual Confidence in Contract Manufacturing. The three presentations were on the following topics: "Building Mutual Confidence in Contract Manufacturing. Each presentation provided detailed explanations of each company's experiences and innovations, and participants asked many questions online, with answers provided after the presentations.
We hope that the special lectures and case study presentations were very meaningful for improving the quality assurance level of each company and will serve as a useful reference in the future.
Special Lecture
1. PMDA's efforts and recent guidance on quality assurance
Mr. Takasei Ishii, Pharmaceutical Quality Control Department, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
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In response to recent fraud cases and supply shortages, the Pharmaceutical Affairs Law was revised in 2025, requiring the strengthening of quality, safety, and stable supply systems. PMDA is continuing activities such as round table meetings and ORANGE Letter to promote understanding of GMP. In this lecture, an overview of the revision of the Pharmaceutical Affairs Law, efforts to ensure quality, and recent examples of guidance were explained.
Case Presentations
2. Measures for internalization of drug formulation process by reusing an existing building
Mr. Tomoaki Suzuki, Quality Assurance Department, Iwaki Plant, Production Division, Asuka Pharmaceutical Co.
<Outline of the lecture>
Asuka Pharmaceutical has chosen to reuse existing buildings by renovating them, placing the highest priority on quality while complying with the Pharmaceutical Affairs Act and other laws and regulations when manufacturing pharmaceutical products in-house. By avoiding the construction of a new building, they were able to secure a high-quality manufacturing environment while reducing the initial investment. In this lecture, he introduced the measures to be taken when renovating the building and points to note such as compliance with laws and regulations, flow line design, and air conditioning control, using actual examples.
2. Efforts to implement a data governance system to strengthen DI
Mr. Tatsuya Fujii, Quality Planning Office, Quality Assurance Division, Otsuka Pharmaceutical Co.
<Outline>
This presentation introduced data integrity (DI) enhancement activities at Otsuka Pharmaceutical based on Chapter 5 "Data Governance" of the PIC/S Guidelines, Self-inspection, CSV response, training, audits, and facility evaluation were conducted based on a risk-based approach. In addition to collaboration among quality assurance, production, IT, and other departments, he explained how they are working for continuous improvement through cooperation with global affiliates and corporate departments.
3. Introduction of the activities of the Quality Culture Project in the GMP Subcommittee of the Pharmaceutical Manufacturers Association of Japan (PMAJ) - Building mutual trust in contract manufacturing
Mr. Hiroshi Fujie, Quality Assurance Department, Chugai Pharmaceutical Co.
<Outline of presentation>
In recent years, collaboration with contract manufacturers (CMOs) is essential in pharmaceutical manufacturing, and mutual understanding of quality culture is important to build trust. The GMP Subcommittee of the Pharmaceutical Manufacturers Association of Japan (PMAJ) conducted a questionnaire survey to clarify the position of contract manufacturers, and also investigated the viewpoints of contract manufacturers in cooperation with the Toyama Pharmaceutical Association and the Toyama Pharmaceutical Consortium. In this lecture, based on these results and considerations, efforts to promote mutual understanding between commissioning and commissioning were introduced.
