Our Approaches in Quality

Kirin Group’s Quality Assurance Policies and Approaches

Kazufumi Nagashima

Senior Executive Officer
Chief Quality Assurance Officer,
General Manager of Quality Assurance Department

The primary objective of the Kirin Group’s quality assurance is to deliver safe and reliable products and services to consumer. We make every effort to ensure product safety and maintain high levels of consumer satisfaction, based on our "Consumer-first approach" and "Steady focus on quality" that form our management starting line.
This guiding principle is incorporated into the Kirin Group’s Quality Policy and Action Principles, which are followed by every Group company around the world in their daily quality assurance practices.

Kirin Group’s Quality Policy

Consumer satisfaction, safe and reliable products and services are our greatest priority based on our "Consumer-first approach" and "Steady focus on quality" that form our management starting line.

Action Principles

1.Consumer satisfaction
We will strive for superior consumer satisfaction by providing "consumer at the heart" services, understanding "consumer voice" driving improved quality, and new values with attention to detail.

2.Safety, Reliability and Trust
We will provide safe and reliable products and services to consumers throughout every step of our business to earn and retain their trust in us.

We will comply with related laws, regulations, and voluntary standards.

4.Quality information Provision
We will provide accurate transparent information that consumers can trust.

5.Objective and recognized quality-assurance practices
We will operate an accredited world class quality-assurance system.

6.Continuous improvement
We will continue to improve and evolve quality-assurance practices tirelessly through technical evolution and developing leading edge skills and capabilities.

Takeshi Minakata

Representative Director of the Board,
President & COO of Kirin Holdings

Our Quality Management

Kirin Group has established the Global Quality Management Principle, which embodies our Quality Policy of being "Consumer-first approach" "Steady focus on quality".

Quality Assurance Approaches We Take in Our Business Domains

We take the following approaches in our businesses to ensure the safety and reliability of our products and services, and to retain the trust and satisfaction of consumer.

Our Approaches in the Food & Beverages Domain

We are committed to meeting the stringent quality control targets established across the value chain in order to continue to deliver safe, reliable, and high-quality products and services to consumer. We use internationally recognized standards for quality assurance to audit and evaluate our quality assurance practices and performance and continually improve them.

Our Approaches in the Health Science Domain

Kirin Group companies manufacture and market foods with function claims and those for specified health use, using proprietary materials developed by our research laboratories.
To deliver the safe and reliable products that consumer expect from Kirin Group, we have combined the best of the quality assurance system established through years of manufacturing alcoholic and non-alcoholic beverages and the dependability assurance system modeled after the one used in the Pharmaceuticals business.

Our Approaches in the Pharmaceuticals Domain

Kirin’s Quality Assurance in the Pharmaceuticals Business

We follow the Good Manufacturing Practice (GMP) and other GxP* guidelines at every step from research and development to manufacturing and marketing to after-sale follow-ups of pharmaceutical products in order to ensure their quality as well as their safety for users, enables us to continue to deliver products with proven effectiveness and safety consistently.

*GxP (Good [variable] Practice) is a set of regulations and guidelines formulated to ensure the effectiveness, safety, and quality of pharmaceutical products throughout every stage from product development to after-sales follow-ups.

Our Response to Quality Management Issues in Kirin Group Companies

Kyowa Hakko Bio Co., Ltd., a Kirin Group company engaged in the manufacture of active pharmaceutical ingredients, was subject to sanctions by regulatory authorities on December 24, 2019, for having manufactured products in a manner departing from authorized methods. *1

The company has since been working closely with other Group companies in implementing business revitalization initiatives to regain the trust of stakeholders. *2,*3

The initiatives include making quality assurance system more stringent and building a more robust manufacturing system. With the compliance of its products with standards progressively verified by the regulatory authorities in GMP compliance inspection, the company is on track to bringing its operations back to the previous level.

The Yamaguchi Production Center of Kyowa Hakko Bio Co., Ltd. collected information related to its response to the above sanctions in the “Report on Results of Improvements in Relation to Business Improvement Order (Final Report).” It submitted this report to the Pharmaceutical Affairs Section of the Health and Welfare Department of Yamaguchi Prefecture on October 29, 2021, and it was officially accepted on the same day.

Kyowa Hakko Bio Co., Ltd. will continue its efforts to strengthen its quality assurance system, develop human resources, and foster a culture that values quality.

Kyowa Hakko Bio Co., Ltd.’s process of manufacturing active ingredients under contract with Kyowa Kirin Co., Ltd., another Group company, was also subject to the regulatory sanctions. Kyowa Kirin Co., Ltd. takes seriously the fact that it has failed to fulfill its responsibility for adequate management and supervision as a marketing authorization holder of pharmaceutical products, and is making company-wide efforts to prevent a recurrence.*4

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