Quality Assurance

Eisai's General Policy on Product Quality

“The quality of every single tablet, capsule and ampule that we produce is integral to the life of the patient.”

This is Eisai's general policy on product quality, with each employee keenly aware that every medicine manufactured by Eisai is directly linked to patients' lives. It is this conviction that is reflected in every aspect of our production activities and we believe that as long as there are people around the world in need of medicine, there exists a mission and a responsibility to continue to assure the stable supply of high-quality pharmaceutical products. To achieve this, Eisai consistently strives for high quality through the introduction of a robust management system that oversees all processes from drug substance and formulation research to production and distribution.

Global Quality Assurance Activities

Eisai believes that quality must be assured until pharmaceutical products are delivered to and used by patients and consumers who need these products. Eisai implements quality control in the manufacturing phase in accordance with its globally unified Good Manufacturing Practice (GMP) standards (international regulations for production and quality management), while placing emphasis on maintaining product quality in the distribution phase. Under this global quality assurance system, Eisai is carrying out quality assurance activities to supply pharmaceutical products that can be used by patients with confidence in every country and region.
The quality assurance departments within the Eisai Group strive to supply products that generate customer satisfaction by pursuing quality that satisfies both the apparent and latent needs of patients and customers.

Initiatives to Strengthen Pharmaceutical Quality System

Eisai is working to strengthen a pharmaceutical quality system that meets patient needs for the stable and continuous supply of products that have met safety and efficacy standards based on “ICH Q10 pharmaceutical quality system guidelines.”

Initiatives against Counterfeit Drugs

As the globalization of the development and distribution of pharmaceutical products accelerates remarkably, there have been reports of an increasing risk of counterfeit drugs not only in developing countries and emerging countries but also in developed countries. In addition to its regular quality-assurance activities, Eisai is implementing global product security activities to ensure that its products are reliably delivered to patients.
In collaboration with regulatory authorities, other companies in the industry and industry groups, Eisai is actively participating in monitoring and establishing measures against counterfeit drugs and the illegal distribution of drugs. When an actual case is detected, Eisai responds quickly by undertaking investigations, taking various legal steps and assuring stable supplies, with these efforts led by the Product Security Execution Committee.
To prevent counterfeit drugs and illegally distributed drugs from reaching the front-lines of medical care, it is necessary to more accurately ascertain the actual state of drug distribution and ensure the proper and safe supply and use of pharmaceuticals. For these reasons, initiatives to ensure the traceability of pharmaceutical distribution are being implemented in regions worldwide and some countries and regions have already established regulations.
Eisai is proactively participating in these types of initiatives promoted by regulatory authorities, pharmaceutical companies and the front-lines of medical care and is also responding quickly to regulations in such countries as China and India. Looking ahead, Eisai will start up internal projects in each region and proceed with preparations for making the quickest possible responses in the U.S. and Europe, where traceability systems as part of the social infrastructure are scheduled for introduction.