Quality Assurance Initiatives
The products of Otsuka Chemical are used in various applications and fields including pharmaceuticals, food products, automobiles, electronics, and housing. By ascertaining individual customer needs and the needs of each industry, the company is creating products that satisfy customers based on stringent quality.
Our company has obtained ISO 9001 Quality Management System certification. Meanwhile, the company’s affiliated entities based in Japan and abroad have obtained certifications such as ISO 9001 and IATF 16949 (a standard for automotive quality management systems), creating an excellently coordinated production and quality assurance system on a global scale.
With a corporate philosophy of "Trust", Otsuka Chemical is working to continually enhance not just product quality, but also the quality of its people, and systems, and work to continue providing customers with reliable products. In this way, our company is improving not only its quality assurance level but also the performance of our company as a whole, the value and quality of its products and services, and pursuing sustainable growth, aiming to increase customer satisfaction and corporate value.
GMP（Good Manufacturing Practice）
GMP (Good Manufacturing Practice) is a set of manufacturing and quality control standards that must be followed to manufacture pharmaceuticals.
Otsuka Chemical's Tokushima Factory has a pharmaceutical bulk plant that has produced β-lactamase inhibitors under the control of pharmaceutical GMP and US cGMP for over 30 years.
We also handle regular inspections by domestic and/or US (FDA) officials, and we are committed to building a quality assurance system that meets customer expectations and contributes to the international medical industry.
ISO 9001 Certification
Otsuka Chemical has obtained the quality management system (ISO9001) certification with the scope of "Design, manufacturing, and contract manufacturing management of chemical products and pharmaceutical active ingredients".
We continue to undergo inspections by external certification agencies, promote continual improvement, and strive to build trust with society (customers) through our technology and commitment.