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Stable supply of products and servicesDelivering Safety and Security

In compliance with the Kirin Group’s quality policy, the Kyowa Hakko Kirin Group aims to provide products and services that earn the satisfaction and trust of its customers.

Quality Assurance Policy of Kyowa Hakko Kirin Group

We do maintain a high level of quality and provide products and services that achieve customer satisfaction.
Safety is our first priority. We do provide products and services that gain the trust of customers through the reliable Quality Assurance System in compliance with applicable laws and regulations.

Quality Assurance System

Kyowa Hakko Kirin has quality assurance organizations at each manufacturing base (plant), as well as quality assurance organizations in each business field. In addition, we have established the Corporate Quality Management Department as a unit to oversee the quality assurance activities of the entire Group. This three-tier structure ensures the sound operation of our quality assurance system.

Pharmaceutical Quality Assurance

In order to consistently supply high-quality pharmaceuticals with guaranteed efficacy and safety, Kyowa Hakko Kirin assures quality at all stages, from research and development to manufacturing and post-marketing, through compliance with the Pharmaceutical and Medical Device Act as well as related laws and regulations, such as Good Manufacturing Practices (GMP), Good Quality Practices (GQP), and Good Vigilance Practices (GVP). Kyowa Hakko Kirin, which aims to make a leap forward to become a global specialty pharmaceutical company, is focusing on the establishment of a quality assurance/safety management system that meets global standards in preparation for the launch of pharmaceuticals in Europe and the United States.

Risk and Disaster Response

To enable rapid and appropriate responses if a product risk emerges, Kyowa Hakko Kirin conducts product recall training, including joint recall exercises with external contract manufacturers and recall exercises that include overseas sales offices. In this way, we prepare for emergencies.
We have formulated a business continuity plan (BCP) for quality assurance activities so that we can continue to fulfill important duties—pharmaceutical supply and information provision—even when there is a disaster, such as a major earthquake.

Quality Assurance at Kyowa Hakko Kirin

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© 2007 Kirin Holdings Company, Limited.

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