Safety and Quality Assurance
We place great importance on providing safe and high-quality products that are produced in compliance with all laws and regulations, including the Pharmaceuticals and Medical Devices Law, so that our products can be used safely.
Quality Assurance and Safety Management System
We work hard to ensure the reliability of all our activities throughout the life cycle of a product, starting from research and development to clinical studies, manufacturing, and marketing of the product, as well as collection and analysis of safety and quality information available during its widespread use after its launch and provision of newly available information on the product.
For plasma fractionation products in particular, it is necessary to take more stringent safety assurance measures than for general pharmaceutical products, because they are made from human blood. We work every day to ensure and improve the safety of our products, not only by performing acceptance testing at the time of receipt of plasma as the raw material, introducing virus removal and inactivation into the manufacturing process, and performing virus testing with high sensitivity (nucleic acid amplification test [NAT]) to ensure that our products satisfy the requirements of biological product standards, but also by introducing our original test parameters for the improvement of safety, etc