Group-wide Cooperation to Ensure Stable Supply of High-Quality Products
Basic Policy
Production departments at the Otsuka group employ a traceability system covering all stages of the supply chain, from raw material procurement to production, distribution, and sales, thereby enabling thorough management throughout the entire supply chain.
Promotion System
The Chemistry, Manufacturing and Control* (CMC) Headquarters established in April 2022 by Otsuka Pharmaceutical’s Pharmaceutical Business Division, aims to deliver high-quality pharmaceutical products to patients faster by establishing an integrated R&D system for active pharmaceutical ingredients and formulations, thereby seamlessly promoting the process from pre-clinical studies to commercialization. In addition to supporting stable production and supply in terms of technology, we pursue the maximization of product value by making full use of CMC technology, including the addition of new dosage forms. The Otsuka Group also works to leverage its strengths through personnel exchange and training that transcends departmental boundaries, collaboration within the Otsuka group, and regular sharing of information on technology and other topics.
- *Chemistry, Manufacturing and Control of APIs and formulations
Held a Group-Wide Global Quality, Production, Supply Chain, and Environment Meeting
As our business grows and our products and sales areas expand, we held a group-wide global conference in February 2023 to deepen mutual understanding and strengthen cooperation among the various departments in the value chain.
Under the theme of “Our value - Thinking at milestones,” 156 participants from 15 countries/regions shared their approaches and issues with each other regarding mechanisms to support stable supply, value creation for the future, and meeting new social needs.
During the conference, we also conducted an award ceremony to commend employees for outstanding initiatives in production activities.
2022 ICH Award – Contributions to the Review of ICH Guidelines
ICH (International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use) is an international council established in 1990 by pharmaceutical regulatory authorities and industry associations in Japan, the United States, and Europe. It promotes the development and marketing of new drugs with high safety, efficacy, and quality, and the continued availability of new treatments for patients through the harmonization of technical and regulatory guidelines on a global scale. Currently, 20 organizations worldwide are members, and 36 organizations including WHO and IFPMA participate as observers. The ICH Award was newly established in 2022 to recognize experts who have made significant contributions to the review of ICH guidelines, and 12 people received the award in the first year. From Japan, three winners from the regulatory side and two from the industry side, including from Otsuka Pharmaceutical, were recognized for their important leadership and sustained contributions to the ICH working groups.
Tomonori Nakagawa
Associate Director, Department of Strategic Management
CMC Headquarters, Otsuka Pharmaceutical
ICH guidelines are tools for obtaining and using the data necessary to deliver better new medicines to patients and medical facilities around the world as quickly as possible, in a scientific and ethical manner. I have been involved in ICH activities since 2010, and as a topic leader of the working group, I have been involved in the development of guidelines* and Q&As in several quality areas based on Otsuka Pharmaceutical’s practices. Currently, I am also involved in the development of training materials to educate about and disseminate the guidelines, and am working to ensure that the guidelines are used appropriately in each country.
- *“Development of Drug Substance”, “Manufacturing and Quality Control”, “Pharmaceutical Lifecycle Management”, and “Quality Risk Management”
Education system
At the Otsuka group, production departments formulate an annual education plan for each production site, provide training on health and safety and good manufacturing practices, as well as regular training on business continuity planning (BCP) and compliance.
Expert training systems
Otsuka Pharmaceutical’s Manufacturing Division initiated a new HR development program in 2021 with the aim of helping develop expert engineers and future managers who can respond globally.
Apart from technical training, we collaborate with in-house departments on management training and we cultivate individuals that can contribute on a global scale through factory training at both domestic and overseas sites.
Employee proposals for improvement
Every company in the Otsuka group works hard to make unique proposals for improvement. As an example, for 41 years Otsuka Pharmaceutical Factory has invited employees to submit proposals related to creativity, with the most useful proposals being adopted and implemented. This system leads to company improvements and raises employees' awareness of creativity. The event continues to spark interest even today. This fiscal year, three employees received the Award for Creativity* for 2023 given by the Minister of Education, Culture, Sports, Science and Technology (MEXT).
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Kenta Hirose
PG Department, Naruto Factory, Manufacturing Division
Otsuka Pharmaceutical Factory -
Makoto Nishine
MP-V Department, Matsushige Factory, Manufacturing Division
Otsuka Pharmaceutical Factory -
Takato Ono
TP-II Department, Toyama Factory, Manufacturing Division
Otsuka Pharmaceutical Factory
*This award from MEXT recognizes the achievement of remarkable results in R&D as well as promoting the understanding of science and technology. The Award for Creativity is given to those who have contributed to technology improvements with outstanding creativity in their field. Employees at Otsuka Pharmaceutical Factory have received these awards for 14 consecutive years.