Quality Committee
Interview with Chairman Kawashima

The Quality 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 that ensures a stable supply of high-quality pharmaceutical products, while the objective of the Formulation Research Subcommittee is to establish a system that ensures a stable and prompt supply of high-quality pharmaceutical products that incorporate state-of-the-art technology at the research and development stage. And the ICH Quality Group represents the Japanese pharmaceutical associations and works with European and US pharmaceutical associations, 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.

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 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. In addition, by replacing tasks that have been handled by humans with digital tools, we believe we can create an environment in which researchers can focus on more creative work and contribute 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 realize this, we are actively communicating with other committees within the Pharmaceutical Manufacturers Association of Japan, such as the Biopharmaceuticals Committee and the International Committee, in order to gather a wide range of expert opinions on the issues under discussion.

The Quality 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 Committee are posted on the website of the Pharmaceutical Manufacturers Association of Japan. Please visit the site.

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