Reliability Assurance

Changing environment(internal and external)

  • Growing calls for pharmaceutical companies to ensure reliability
  • Diversification and increasing complexity of drug discovery modalities


  • Growing demand to supply high-quality products
  • Establishment of quality and safety management systems in new Modalities


  • Tighter regulations at home and abroad
  • Quality issues in domestic and international supply chains

Medium-term business plan
Vision 110 –Stage1– initiatives

Business strategyStrengthening reliability assurance system to support comprehensive business development

  • Strengthen our legal compliance system for pharmaceutical matters
  • Promote prompt and reliable responses to changes in the environment surrounding reliability assurance

Reliability assurance system

To ensure the stable supply of high-quality products, the Group complies with the Good Quality Practice (GQP) and Good Vigilance Practice (GVP) standards for pharmaceuticals. In the diagnostics business, we have established a system that conforms to the Quality Management System (QMS) standard for manufacturing and managing medical devices and in vitro diagnostics and quality control.

Our Quality Assurance & Reliability Division, which plays a central role in this process, is independent of the R&D, manufacturing, and sales divisions. It engages in unified product reliability assurance initiatives to provide products and information that patients and medical practitioners can use with confidence.

In addition, we promote proper use of our products and assure their reliability by faithfully and promptly responding to aftersales inquiries from patients and medical practitioners about products’ efficacy, safety, and quality.

Quality assurance

The Kyorin Group has a quality policy for both ensuring product quality and providing stable supplies. We are strengthening operation of our manufacturing centers through management of quality risk based on scientific evidence. For pharmaceuticals, we have established a system to supply high-quality products based on GMP standards in cooperation with Group plants and other facilities from the development stage.

We have also set up a distribution system that conforms to Good Distribution Practice (GDP) standards for pharmaceutical products. After launches, we conduct quality assurance in compliance with GQP standards to ensure the quality and stable supply of products, from development and manufacture to distribution.

For in vitro diagnostics and medical devices (diagnostics business), we are committed to providing high-quality products by practicing quality assurance in compliance with QMS standards across all stages, from design and development to sales.

To maintain product quality and ensure integrity during the distribution process, we have established a GDP-compliant distribution system. Under this system, which includes on-site inspections, we confirm that quality control is performed properly at storage and distribution companies.

Safety management

Drugs can be effective for treating patients (benefits) but can also have adverse side effects (risks). Therefore, during the development phase, we collect and manage safety

information on investigational new drugs and appropriately monitor and evaluate changes in the safety profile of those drugs. After a product is launched, moreover, side effects unforeseen during the development phase may become apparent.

For this reason, it is important to collect and analyze a wide range of information about benefits and risks after a product is launched and to quickly provide appropriate information to the medical community, with the balance taken into account.

The Kyorin Group formulates risk management plans and collects and manages safety information by individual product. We also conduct drug-monitoring activities for pharmaceuticals and medical devices in compliance with GVP standards to ensure their safety and proper use. In addition, we conduct postlaunch investigations to collect and evaluate information on the safety and efficacy of pharmaceuticals in compliance with Good Post-marketing Study Practice (GPSP) standards.

Quality Policy

KYORIN Pharmaceutical’s Quality Policy

“Kyorin continues to fulfill its mission of cherishing life and benefiting society by contributing to better health.” Following this corporate philosophy, we provide high-quality products that are trusted by patients and medical practitioners.

  • We engage in appropriate quality-related activities in compliance with relevant laws, regulatory requirements, and internal standards.
  • We practice quality risk management based on scientific knowledge to ensure product reliability.
  • We strive to raise employee awareness of quality and foster a quality-driven culture with ongoing education.
  • We work closely with subcontracted manufacturers and suppliers to ensure stable supplies of high-quality products.
  • We listen and respond sincerely to patients, medical practitioners, and others and actively strive to improve product quality.

Manufacturing and Sales Structure


Manufacturing and Sales Structure - Pharmaceuticals

In vitro diagnostics/medical devices

Manufacturing and Sales Structure - In vitro diagnostics/medical devices