Reliability Assurance System

passing variety international standards with thorough quality assurance

At Alfresa Pharma we have built a system to ensure reliability over the entire product life, from research and development to production, manufacturing, and after-sales, and our Pharmaceutical Research and Development Division, Diagnostic Reagent Research and Development Division, Medical Device Development Division, Production Division (Okayama Plant and Chiba Plant), Safety Management Division, and Quality Assurance Division work closely together on the pharmaceuticals, diagnostic reagents, and medical devices to be manufactured and sold. In addition, we have implemented strict quality control in the Contract Manufacturing of products from other pharmaceutical manufacturers and imported bulk pharmaceuticals. We are compliant with GQP,GVP,GCP,GMP,QMS,GPSP and reliability standards, and have passed international standards such as ISO9001, ISO13485 and CE marking. We aim to improve and ensure the quality of our people, products, and information.

Quality Assurance Flow