Quality Assurance

To ensure safety of our products, Nichi-Iko carries out various tests for all drugs and any manufacturing processes critical for ensuring the product quality. We take prides in our high quality generic drugs with high grade of safety.

Ensuring quality

We manufacture generic drugs under the same GMP (Good Manufacturing Practices) standards imposed by Ministry of Health, Labour and Welfare regulations as originator drug manufacturers do. In accordance with this, Nichi-Iko's Quality Control Department, which is independent from the Manufacturing Division, performs various tests including acceptance tests for raw materials and materials, in-process tests during manufacturing processes, and release tests or qualification tests for finished goods to be distributed. We are very serious to strictly control and confirm our product qualities.

Scientific validation is used as a multi-faceted means of verifying that our manufacturing equipment, procedures and control methods are as they should be.

Our Quality Assurance Division takes the lead constantly to ensure manufacturing and quality control are carried out appropriately in line with GQP (Good Quality Practice) regulations issued by the Ministry of Health, Labour and Welfare.

This collaborative check system of Quality Control Department and Quality Assurance Division provides superior quality products.

Ensuring Safety

Drug effectiveness comes with side effect risk. To minimize side effect risk and allow drugs to be administrated appropriately, providing information on drug safety and efficacy is essential.

Our Safety Management Department collects such post-marketing safety information. They evaluate and analyze safety information. If any changes are reported, we revise the package insert before putting it in a drug box and inform our Medical Representatives as well as external pharmacists immediately. In order to share information, we make good use of the internet as a communication tool or visit doctors and pharmacists.