The scope of quality assurance of pharmaceutical products extends to the point where it is delivered to and actually 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 based on Good Distribution Practice (GDP) for medical products (standards for proper distribution) in order to supply pharmaceutical products to patients with the quality just as manufactured. Under this global quality control and assurance system, Eisai is developing activities to maintain quality assurance in order to enable the supply of pharmaceutical products that can be used by patients with confidence in any country or region of the world.
The quality 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.
Ensuring integrity (completeness, consistency, accuracy) of research data and production data, etc. is extremely important for pharmaceutical companies because it is the evidence to secure the product safety and reliability. Failure to ensure the integrity of these important data may have a significant impact on business performance, including delays and discontinuations of new drug development, product recalls, and suspension of sales.
In the Group, we are working to strengthen the integrity of data that supports the quality of our products in particular, by systematizing data recording, verification, approval, and storage, as well as establishing and operating an appropriate internal control system. We also continue to conduct training sessions for employees involved in important data in Japan and overseas.
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 internal projects in each region and proceed with preparations for making the quickest possible response in the U.S. and Europe, where traceability systems as part of the social infrastructure are scheduled for introduction.