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

Manufacturing and Sales Structure

Pharmaceuticals

In vitro diagnostics/medical devices