Proper Quality Assurance and Safety Management Practices
In order to ensure quality and a stable supply, we practice proper quality assurance and safety management in compliance with GMP (* 1), GQP (* 2), GVP (* 3) and other laws and regulations relating to pharmaceutical products.
To ensure that consumers can use our pharmaceutical products with confidence, decisions on whether or not to ship products to the market are made only after confirming that manufacturing, testing and inspections have been conducted properly in accordance with laws and regulations. Further, we conduct post-marketing safety management of pharmaceuticals by collecting, evaluating, and examining safety reports (information on adverse drug reactions etc.) issued both in Japan and abroad, and if required, implement prompt safety assurance measures.
*1 GMP: Standards for Manufacturing Control and Quality Control for Drugs and Quasi-drugs
*2 GQP: Standards for Quality Control for Drugs. Quasi-drugs, Cosmetics and Medical Products for Regenerative Medicine
*3 GVP: Standards for Post-marketing Safety Management for Drugs. Quasi-drugs, Cosmetics, Medical Devices and Medical Products for Regenerative Medicine