Quality Assurance
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Quality Assurance System
The Daito factory buildings, both for active pharmaceutical ingredients (APIs) and for formulation products, meet not only the Japanese Good Manufacturing Practice (GMP) standards for pharmaceutical manufacturing management and quality management but also the current GMP (cGMP) regulations in the U.S. and the EU GMP Guidelines. Therefore, the Company has earned the trust of major pharmaceutical manufacturers and other parties and is capable of manufacturing products for overseas markets.
The Company also meets Good Quality Practice (GQP) standards for quality management and Good Vigilance Practice (GVP) standards for safety management. We boast an integrated management system that covers the quality of both APIs and formulation products, steps in the manufacturing process, etc.
Our Quality Assurance System
The quality of our products is maintained at a high level through cooperation between related in-house departments under the leadership of Regulatory Assurance. We strive to always maintain our high level of manufacturing management and quality management while keeping a close eye on not only Japanese GMP standards but also the latest overseas GMP guidelines.
Quality Policy
We perform thorough manufacturing management and quality management in our daily production operations so that patients, medical professionals, client companies and all those involved can take or handle our pharmaceutical products without concern. Furthermore, we are seriously committed to enhancing our manufacturing management and quality management.
Quality Management
We conduct tests to confirm that raw materials delivered to us meet the prescribed specifications and strictly check that our products conform to the specifications written on the relevant application forms.
Responsible Officers
To comply with the revised Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices, which came into effect in August 2021, Daito has created a Quality Manual under the supervision of three directors who serve as “responsible officers” and begun to use the manual strictly. The responsibilities of responsible officers include fostering appropriate collaboration between different units in increasing product quality and providing sufficient and appropriate management resources (staff, materials, equipment, devices, environments, etc.) for quality assurance.
Quality Assurance Building
In response to recently increased product output, heightened quality requirements imposed on pharmaceutical companies, and the need to devote efforts to passing an inspection by the U.S. Food and Drug Administration (FDA), we strive to strengthen our quality assurance system by increasing the number of quality assurance staff members. In addition, the Quality Assurance Building is equipped with various forms of tangible support for our quality assurance system.