Quality & Technology Committee
Interview with Chairperson Kawashima
The stable supply of pharmaceutical products is a strong demand from society and an important responsibility for the pharmaceutical industry to fulfill. To support this mission from the aspect of "quality," the Quality & Technology Committee is working to improve the quality of the entire industry while responding to changes in the environment, such as domestic and international regulatory trends and digital technology. At the core of these efforts is the cultivation of a "quality culture" that goes beyond mere procedural compliance. We interviewed Mr. Nobuo Kawashima, Chairperson of the Committee, about the current challenges and the vision for the future of pharmaceuticals in Japan.
Utilization of New Technology and International Harmonization for More Stable Supply
Supporting Technological Innovation and International Harmonization with a Culture of Quality
Fostering a "quality culture" is the key to a stable supply of pharmaceuticals
The Quality & Technology Committee's basic policy is to "support the stable supply of pharmaceuticals from a quality perspective. To fulfill this mission, we promote activities from each specialized area under three structures: the GMP Subcommittee, the Formulation Research Subcommittee, and the ICH Quality Group.
For example, the objective of the GMP Subcommittee is to strengthen and improve the reliability of the system to ensure a stable supply of high-quality pharmaceutical products, while the objective of the Formulation Research Subcommittee is to establish a system to ensure a stable and prompt supply of high-quality pharmaceutical products with state-of-the-art technology at the research and development stage. And the ICH Quality Group represents the JPMA in Japan and works with European and US JPMAs, foreign administrations, and international regulatory harmonization. In this way, the three pillars, from manufacturing to R&D to international harmonization, work together to support consistent quality throughout the entire lifecycle of pharmaceutical products.
In order to maintain a stable supply of high-quality pharmaceuticals, compliance with established procedures and rules is a natural prerequisite. However, this alone is not enough. What I consider most important now is to foster a "quality culture" that should take root throughout the entire organization.
Quality culture can be described as an attitude and culture in which each individual takes the viewpoint of "Is there anything more we can do for the patients? Although quality culture itself has become widespread in the industry, it is difficult to objectively measure the degree to which it is fostered, and many companies are still struggling with the process of trial and error. A particular challenge is the gap in perception that arises between pharmaceutical companies and contract manufacturing organizations when outsourcing manufacturing.
This is not simply a communication problem, but stems from a lack of information sharing when transferring technology and insufficiently shared expectations of each other. The assumption that "it is the other party's domain" obscures information that should be shared, resulting in a gap in the perception of quality. In order to solve this problem, we stand between the two parties, organizing and sharing the ideas of both parties through questionnaires and other means, and establishing a forum for honest discussions to build a relationship of trust. We believe that deepening mutual understanding across the industry as a whole, beyond relationships between individual companies, will lead to fostering a true culture of quality.
We will also work on the use of AI and other new technologies and international harmonization
The environment surrounding the pharmaceutical industry is changing dramatically with the evolution of digital technology. We see this change as an opportunity, and have begun to seriously consider the use of AI and robot technology as a project of the Drug Formulation Research Subcommittee and as a task force across the Quality & Technology Committee. Specifically, we expect to increase the efficiency and speed of test method development, as well as improve the sophistication of the investigation of the causes of quality defects through the monitoring of large volumes of data. We also believe that replacing tasks that have been handled by humans with digital tools will create an environment in which researchers can focus on more creative work, thereby contributing to improving Japan's development capabilities.
At the same time, an international perspective is also essential, and the ICH Quality Group is actively involved in the formulation of international rules on quality in cooperation with regulatory authorities and pharmaceutical organizations in Europe and the United States. Establishing a high-level quality assurance system that can be used globally is the cornerstone for enhancing the reliability of the Japanese pharmaceutical industry and, in turn, maintaining a stable supply. In order to achieve this, we are actively communicating with other committees within the JPMA, such as the Biopharmaceutical Committee and the International Affairs Committee, in order to gather a wide range of expert opinions on the matters under discussion.
The Quality & Technology Committee, including each of its subcommittees, is supported by all companies. We intend to continue to compile our activities and disseminate them from member companies and, if necessary, make proposals to related organizations. As a result, we will contribute to our basic policy of "maintaining a stable supply".
The structure and activities of the Quality & Technology Committee are posted on the JPMA website. Please visit the site.
Quality & Technology Committee Website]
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