Quality Assurance
Policy and Strategy
Pursuant to its global Quality Policy, the Kyowa Kirin Group is committed to providing products and services that earn the satisfaction and trust of its customers.
Kyowa Kirin Group Quality Policy
Revised on November 1, 2023
1. Purpose
The Kyowa Kirin Group will contribute to the health and well-being of people around the world by consistently providing world-class quality pharmaceutical products and services in compliance with our global quality, safety and compliance policies.
This policy is to describe the basic principles for quality of the Kyowa Kirin Group.
2. Scope of Application
This policy applies to all personnel including officers and employees of the Kyowa Kirin Group. The Kyowa Kirin Group will request all of our business partners and agents engaged in our products and services to act in accordance with the basic principles stated in this policy.
3. Definition of Terms
- GxP means GLP (Good Laboratory Practice), GCP (Good Clinical Practice), GMP (Good Manufacturing Practice), GQP (Good Quality Practice), GDP (Good Distribution Practice) and GVP (Good Vigilance Practice).
- Quality management system is a formalized system that documents processes, procedures, and responsibilities for achieving quality policies and objectives.
4. Basic Principles
We will act in accordance with the following basic principles.
- Compliance and Continuous Improvement
- We conduct our business in compliance with all global laws, regulations, and guidelines related to GxP. To ensure compliance, we will continuously improve our quality management system.
- Cooperation and Collaboration with Stakeholders
- We maintain sound relationships with regulatory authorities, suppliers, and contractors around the world to ensure a continuous supply of high-quality pharmaceutical products.
- Predictive and Preventive Quality Assurance
- We strive to prevent problems before they occur by using information and digital technologies to proactively identify and address risks.
- Fostering a Quality Culture
- We foster a healthy Quality Culture in our organization, openly discussing issues, and collaborating with our teams to ensure that we always act with integrity from the patient's perspective.
Governance
Global QA Vision and Mission
We contribute to patients by following our Vision and executing our Mission.
Our Vision is to lead in Quality by fostering a culture of continuous improvement and innovation across all processes, systems, and products, enabling us to deliver life-changing value and bring smiles to our patients.
Our Mission is to assure safe, effective, and high-quality products and services by executing our strategic Global Quality Roadmap. We are committed to quality, compliance, and integrity, empowering our teams to create value for stakeholders and build trust with our patients.
A Quality Culture is centered around three key components: establishing a clear vision, fostering a set of shared values that all employees embody, and providing strong leadership. In a healthy Quality Culture, you will find science-based decision-making, effective risk management, robust data integrity, compliance, a supportive management structure, a proactive approach to preventing issues before they arise, and a mindset focused on continuous improvement.
Our ultimate goal, as part of our Global Quality Roadmap, is to achieve a competitive advantage by developing a world-class Quality System and nurturing a strong Quality Culture.
Jonathan Patroni
Organization for Global Quality Assurance
As illustrated in the figure below, the Global Quality Assurance function is structured such that the Global Quality Head reports directly to our Chief Compliance Officer (CCO). The Global Quality Head oversees all Quality Assurance activities across regions, including JAPAC, North America, and EMEA, as well as all Global QA functions. Regional QA groups collaborate closely with the five Global QA functions, which possess high levels of expertise, to ensure a globally consistent structure for Quality Assurance and oversight. Our Global Quality Assurance framework has been designed and implemented with the highest priority placed on patient safety, compliance, and customer satisfaction.
Specific Initiatives
Quality as a Strategic Enabler of Innovation
Our portfolio of advanced biopharmaceuticals and antibody therapeutics continues to grow in scientific and technical complexity. In this environment, GQA harmonizes the acceleration of innovation with rigorous adherence to regulatory requirements. We operate with a clear conviction: quality is not a barrier to progress but rather a strategic foundation for sustainable growth.
Deepening a Patient-Centric Quality Culture
Quality is not the sole responsibility of the GQA function, it is the responsibility of every employee at Kyowa Kirin. Through leadership engagement, routine GxP training, and clear accountability, we ensure that patient-first decision-making is embedded throughout the organization.
Risk-Based Lifecycle Management
GQA applies scientific judgment and proactive risk management throughout the entire product lifecycle. From development through commercial supply, we ensure product integrity and supply reliability through early detection of potential issues, rapid escalation, and effective response.
Through close collaboration with Development, Manufacturing, Supply Chain, Regulatory Affairs, and Pharmacovigilance, we enable swift and consistent decision-making that prevents supply disruptions and protects patients.
Quality Integration Across Our Global Manufacturing Network
GQA conducts comprehensive quality oversight of both our internal manufacturing sites and external Contract Development and Manufacturing Organizations (CDMOs). Our internal sites, including our flagship Kyowa Kirin Biotech facility in Takasaki, play a vital role in ensuring stable supply and technical excellence.
Concurrently, we are actively supporting quality preparation and design integration for our new manufacturing facility under construction in Sanford, North Carolina, USA, a strategic investment in our future global supply network. We work closely with our external partners who provide additional capacity, flexibility, and global reach. Through close collaboration with manufacturing leadership, operations teams, and external partners, we drive compliance, inspection readiness, continuous improvement, and consistent execution of quality standards.
The Future of Quality: Powered by Data and Digital
Quality Key Performance Indicators (KPIs)―including process capability, deviation management, Right First Time (RFT) rates, and inspection readiness―provide visibility into network-wide performance and enable data-driven decision-making and early intervention. Digital transformation and data integrity are critical pillars of our quality strategy. We are actively modernizing quality systems, strengthening Computerized System Validation (CSV), and leveraging data to generate insights and drive continuous improvement. Reliable, compliant data forms the foundation for sound decision-making, operational excellence, and regulatory confidence.