Pharmacovigilance and Quality Assurance

Pursuant to its Quality Assurance 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

Established on February 17, 2009
Revised on November 22, 2019

We contribute to the health and well-being of people around the world by ensuring the highest quality commercial and clinical medicines are available and by always adhering to global quality, safety and compliance policies.

  1. 1.
    We utilize People, Process, Systems / Technology to conduct reliable and ethical activities in alignment with our compliant and effective GxP quality management system.
  2. 2.
    We maintain healthy relationships with all stakeholders and properly oversee suppliers and contractors.
  3. 3.
    We comply with all GxP global laws, guidelines and industry rules in our activities.
  4. 4.
    We utilize data and risk principles to drive decisions based on long-term outcomes, while always keeping our patients at the center of our decisions.
  5. 5.
    We foster a positive quality culture and always strive to continuously improve.

Quality Assurance System

The Kyowa Kirin Group has a global organizational structure in place to ensure that our global quality assurance systems are functioning properly. Within the global quality structure, quality assurance organizations are established at each plant, as well as in each region, and the Global QA Head and Quality Management Department oversees quality assurance activities globally. Our quality assurance activities are performed in compliance with relevant global laws and regulations, with top priority on patient safety and satisfaction.

Group Quality Assurance Framework

Group Quality Assurance Framework

Group Quality Assurance Framework

lol下注Group Quality Assurance Framework

Quality Assurance of Pharmaceutical Products

Under the Policy for Safety, Quality and Regulatory Affairs in Pharmaceutical Business, Kyowa Kirin strives to supply pharmaceutical products of excellent quality, along with high-value-added information, to customers with the aim of contributing to their health and well-being.

Policy for Safety, Quality and Regulatory Affairs in Pharmaceutical Business

We will supply products of excellent quality along with reliable information to customers.

In keeping with our Policy, we adhere to the following four principles (4Cs)

  1. (1)
    Sincere response (Cordiality)
  2. (2)
    Activity with all members participating (Cooperation)
  3. (3)
    Consistent reliability assurance system (Consistency)
  4. (4)
    Compliance with laws and regulations and responding to social demands (Compliance)

Appropriate Information Provision

lol下注All pharmaceutical products have both benefits for patient treatment and risks in the form of adverse reactions. The balance between the benefits and risks of a drug can be changed depending on the data accumulated from the drug development phase through to the post-marketing phase. Undertaking ongoing activities to maximize a drug's benefits and minimize its risks is positioned as one of the basics of drug development in terms of pharmacovigilance and quality assurance (PV & QA). To afford greater safety and peace of mind to patients using our pharmaceutical products, we implement timely assessments and reviews of drug benefits and risks, and ensure that appropriate information is provided to medical settings, for example, by conducting pharmacovigilance activities based on drug risk management plans and safety assurance measures.

Structure for Appropriate Information Provision

Strengthen global PV&QA System

To manufacture and sell new in-house brand drugs in Japan, Europe and the United States, we urgently need to build a PV & QA system that fulfills Good Practice (GxP) standards in each of these three regions. To this end, we are holding discussions at our global safety and quality committees composed of relevant managers at the head office and overseas subsidiaries, in light of our global policies for safety and quality matters. In addition, we are strengthening our global PV & QA system through activities undertaken by our product-based global safety teams and issue-based global quality teams as well as through audits on overseas subsidiaries.

Furthermore, we hold annual workshops on PV & QA for relevant staff members at overseas subsidiaries; dispatch and station staff at overseas subsidiaries; send staff to academic institutions in Japan for study; and make opportunities for staff to participate in various academic society activities. We are striving to improve teamwork, a critical factor for global problem solving, and continuing to develop professionals capable of sustaining and enhancing our global PV & QA system.

  1. *
    GxP stands for "Good x Practice,"which refers to the standards established to ensure the reliable efficacy, safety and quality of a pharmaceutical product from the development stage to the post-marketing stage. Japan has standards such as GCP, GLP, GVP, GPSP, GMP and GQP. Globally, each region has its own set of GxP standards.

Measures against Risks and Disasters

We have been providing all employees engaged in pharmaceutical business with education on the risks of drugs, including the history of health hazards caused by drugs, and on the GVP guidelines in our belief that it is our responsibility as a pharmaceutical company to do so.

To enable us to respond promptly and appropriately should a risk concerning one of our products materialize, we perform joint training with external manufacturing contractors and conduct global recall drills involving all sales sites including those outside Japan.

Moreover, we have in place our Business Continuity Plan (BCP) for our reliability assurance activities to sustain our important responsibilities of supplying pharmaceutical products and providing information in the event of a large-scale earthquake or other disasters. Notably, we have formulated concrete BCP action manuals for our pharmacovigilance activities and product shipment validation procedure, which must be continued without interruption. This is because these activities include collection and provision of safety information, and assessment, reporting and provision of findings, which are critically important operations required of a pharmaceutical company.