Sustainability

Improvement of Products Quality

Policy/Philosophy

Our Group sets the quality policy "Providing products and services that satisfy customers". Based on this policy, we set mid-term quality targets and KPIs for materiality, and are working on quality activities. In addition, we are continuously improving our management system and operations every year by implementing an annual plan in line with PDCA cycle.

We will continue to strengthen our ability to respond to increasingly diversified and sophisticated market demand and aim for further growth as a company that contributes to society.

System

Our quality assurance framework is based on the international quality management system standard, ISO 9001. Each of our plants has obtained ISO 9001 certification and maintains it through ongoing reviews and renewals conducted by independent certification bodies.

We have established a quality assurance division at each plant that is independent of the manufacturing divisions. Each quality assurance division is responsible for inspecting the quality of each product. Furthermore, the quality assurance division of the head office conducts quality audits to each plant and affiliate.

The Quality Assurance Committee is held regularly as an organization to promote quality assurance activities on a company-wide basis. In the committee, the results of our activities and our affiliates activities, the results of quality audits and the status of improvements, and complaints and status of corrective actions are reported. The committee discusses the policies for activities of quality assurance for next year. These discussions are reported to the Board of Directors, and further improvements are made through management reviews to ensure that we are fully prepared.

Indicators

Number of complaint cases

Classification	FY2023	FY2024	FY2025
Functional or Ingredient	2	7	5
Foreign-substance	4	2	3
Packaging	28	29	17
Delivery	9	6	7

Number of complaint cases: A same kind of complaints is counted as one case.

Number of complaint cases: A same kind of complaints is counted as one case.

In FY2025, the number of complaints cases decreased compared to these in FY2023 and FY2024. In FY2025, complaints related to packaging and delivery continued to account for a relatively high proportion; however, the case number decreased by approximately 30% compared with FY2024. The number of serious complaints was zero in FY2023, three in FY2024, and two in FY2025, both of which were of the same nature. We will continue to set “zero serious complaints” as a KPI and remain committed to ongoing preventive measures.

Activities

We promote initiatives that aim to realize our quality policy of “Providing products and services that satisfy customers”. These initiatives are based on the keywords Q・S・G.

Prevention of Quality Fraud and Data Tampering（G）

As part of our corporate governance framework, we are committed to preventing quality fraud and data tampering. To enhance compliance awareness and ensure its effectiveness, we establish standard documents, provide employee training programs, and verify quality compliance through audits.

From FY2022 to FY2025, we verified the consistency between manufacturing records and regulatory filings, such as approval documents, as well as customer requirements. We also confirmed the absence of quality-related misconduct or inappropriate practices. Where deficiencies or potential risks were identified, we implemented corrective guidance and provided additional training.

In addition, each plant is working to develop a framework that is less likely to cause errors, fraud, or tampering by reducing manual operations and work, and by enhancing data integrity through the introduction of laboratory information management system (LIMS), etc. In the sites and departments where LIMS are not introduced, we have established a control system for issuing test results using an electronic signature system to obtain confirmation and approval logs, thereby preventing quality frauds and falsification of data.

Fostering Quality Culture（S,G）

To promote quality-conscious behavior among all employees, we established the "QUALITY BEHAVIOR MODEL" in FY2021 and continue to communicate it regularly as a key message from top management. In 2022, we conducted company-wide training on “Prevention of quality irregularities” and “Change control” to reduce quality risks arising from changes in business divisions units and manufacturing plants sites; In FY2023, we conducted company-wide education on the "QUALITY BEHAVIOR MODEL" and education on “Change Control” for laboratory researchers . In FY2024 and FY2025, we provided education on “Examples of Quality Fraud that have occurred in the society” and “Potential unintentional Quality Misconduct within the Company”, respectively. These education programs were conducted for employees in the research, planning, development, procurement, production, logistics, and sales departments that are involved in product quality. We will continue to implement company-wide in-house education programs emphasizing the importance of quality compliance.

Logistic and Supplier Management（Q,S）

In the procurement of raw materials, we appoint supplier management managers for each business segment in accordance with our “Supplier Management Standards.” Key supplier information, including responses to quality management questionnaires and results of regular quality audits, is systematically managed and shared across departments. In addition, we strive to maintain quality through robust change control processes that require thorough prior review and impact assessment. In logistics, we are committed to achieving higher quality by reviewing and improving processes from packaging through transportation, with the aim of reducing quality issues arising in these stages.

Response to Regulatory Authorities（S,G）

We obtained various pharmaceutical-related business licenses and are subject to the U.S. Food and Drug Administration (FDA) inspections, the Pharmaceuticals and Medical Devices Agency (PMDA) inspections, and prefectural agency inspections to ensure that our quality assurance system for pharmaceutical products meets regulatory requirements.

Quality Assurance of Data at the Laboratories（Q,S,G）

Biological Research Laboratories is confirmed for compliance by the Ministry of Agriculture, Forestry and Fisheries as a testing facility capable of generating application data for the registration of agrochemicals. In addition, Chemical Research Laboratories and Biological Research Laboratories prepare documents for pharmaceutical application in accordance with the standards established by the Ministry of Health, Labour and Welfare. The quality assurance department located in the head office, which is highly independent, audits these data to create highly reliable application documents to enable to submit them to regulatory authorities.

Internal Network of Product-quality Intelligence（Q,S）

We established the corporate network to collect and evaluate customer complaints for our products promptly and take necessary corrective actions. Customer feedback is promptly shared through this network with the sales, manufacturing, and quality control divisions, enabling timely responses to customers and continuous quality improvement.

In FY2023, we introduced the new company-wide quality-information system that unifies, in addition to customer's complaints management, the management of documents related to quality, all internal quality problems, corrective & preventive actions and supplier information, and transferred from our previous systems. We will continue to make further improvements to provide customers with safer, higher-quality products in the future.