For the purpose of quality assurance based on ministerial ordinances, including Good Manufacturing Practice guidelines (GMP, Standards for Manufacturing Control and Quality Control for Drugs and Quasi-drugs), Good Quality Practice (GQP, Standards for Quality Assurance for Drugs, Quasi-drugs, Cosmetics, and Cellular and Tissue-based Products), and Good Vigilance Practice (GVP, Standards for Post-Marketing Safety Control for Drugs, Quasi-drugs, Cosmetics, Medical Devices, and Cellular and Tissue-based Products), we have established the Quality & Safety Affairs Division, and are committed to manufacture and supply only high-quality, safe medicines. In addition, we strive to conduct thorough training for the related employees, and make day to day efforts to build a system that ensures a higher level of quality.

Pharmaceutical Quality System (PQS)

To deliver safe and high-quality products, we have established Pharmaceutical Quality System (PQS) and set quality policy for continuous improvement.

Our Quality Assurance System

In order to put our quality policy into practice, we repeat and work to further improve the following cycle: (1) Establishment of quality targets, (2) Activities toward the quality targets, (3) Discussion at product quality meetings, (4) Quality management reviews by senior management, and (5) Establishment of quality targets for the next year.

We conduct the manufacturing and quality control efficiently and effectively by putting risk management into practice.
For each production batch, the manufacturing and quality control records are reviewed carefully, and implementation of change control, deviation management and validation ensured before the final judgment is made on whether the products are suitable for release.
We monitor through the product quality review whether the products are being manufactured in a properly controlled state. In addition, we investigate necessity of follow-up activities such as improvement or others, and aim to improve the product quality by achieving the improvement when necessary.

Three Keywords for Maintaining Quality

We have established a GMP organization compatible with global standards.

We have passed inspections by regulatory authorities from Taiwan and South Korea, which are PIC/S members, in addition to Japan's Pharmaceutical and Medical Devices Agency (PMDA). We are well equipped with a quality assurance system, allowing us to abide by the requirements of these regulations and supply high-quality products. Furthermore, we make efforts to enhance our system to supply high-quality medicines worldwide, conforming to not only PIC/S GMP but the other global regulations, as well as strengthening our facilities, and maintaining and improving the quality system.

We strictly manage each manufacturing process.

In conformity with GMP requirements, we perform quality control in each process step from acceptance testing of raw materials and packaging materials for the production of medicinal products, testing of in-process controls,, testing of finished medicinal products to shipment. We are well equipped with testing and examination equipment, and ensure reliable quality while incorporating up-to-date analytical techniques.

We maintain and upgrade our system through organization-wide efforts.

We are committed to manufacture products that conform to guidelines in and outside Japan through organization-wide efforts, and have performed continuous improvement of a quality of medicines through the Pharmaceutical Quality System (PQS).

Personnel who engage in quality assurance

It is only through excellent human resources that a reliable quality system is implemented. We develop competency of personnel who engage in the quality assurance activities through internal and external training and experience. In addition, we promote compliance activities and make efforts to foster the Quality Culture of "quality-first practice".