Seikagaku’s mission is to provide society with a continuous supply of beneficial, high-quality pharmaceuticals and medical devices. We have constructed corporate quality assurance and compliance systems in accordance with laws, regulations, and standards.

Quality compliance system

To continuously provide patients and medical professionals with high-quality pharmaceuticals and medical devices, Seikagaku makes maximum effort to ensure quality at every stage, from R&D to post-marketing by complying with the Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices (“PMD Act”) and a collection of regulations and guidelines called GxP.* In Japan, as a marketing authorization holder, we have developed a system with three key roles (general marketing compliance officer, quality assurance supervisor, and safety management supervisor) and implement appropriate quality management and pharmacovigilance operations.

To continue to reliably provide pharmaceuticals and medical devices required by patients around the world, we will strive to maintain and enhance quality assurance and compliance systems in accordance with global standards.


* GxP is an abbreviation for Good XXX Practice, a collective term for standards established to ensure the efficacy, safety, and quality of pharmaceuticals and medical devices from the R&D stage to post-marketing. (See the diagram to the right.)

Laws and Regulations Governing Pharmaceuticals and Medical Devices

 

  • PMD (Pharmaceutical and Medical Device) Act
    Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices
  • GLP:Good Laboratory Practice
    Standards for conducting non-clinical studies on safety
  • GCP:Good Clinical Practice
    Standards for conducting clinical studies
  • GMP:Good Manufacturing Practice
    Standards for manufacturing control and quality control in manufacturing
  • GVP:Good Vigilance Practice
    Standards for post-marketing safety management of drugs, quasi-drugs, 
    cosmetics and medical devices and regenerative medicine products 
  • GQP:Good Quality Practice
    Standards for quality control of products
  • GPSP:Good Post-marketing Study Practice
    Standards for conducting post-marketing surveys and studies on drugs
  • QMS:Quality Management System
    Ordinance on Standards for Manufacturing Control and Quality Control of Medical Devices and In Vitro Diagnostic Reagents

Quality management system based on global standards

To provide a stable supply of high-quality pharmaceuticals and medical devices, according to our Quality Policy, we have developed a quality management system that ensures the reliability of our products worldwide. At the development stage, we ensure reliability under Good Laboratory Practice (GLP) and Good Clinical Practice (GCP). To guarantee quality assurance in accordance with legal and regulatory requirements after product launch, each year we systematically conduct self-inspections and internal audits to confirm the status of operation of the quality management system and promptly take corrective and preventive actions as necessary.

Seikagaku has obtained ISO 13485 certification for the development, manufacture, and distribution of sodium hyaluronate-based viscoelastic products for the treatment of osteoarthritis of the knee and periarthritis of the shoulder. We strictly maintain and control quality at all stages from product design and development to post-marketing in conformance with these manufacturing control and quality assurance systems.

ISO 13485 is an international standard for quality management systems established by the International Organization for Standardization (ISO) that prescribes requirements concerning the design, development, and manufacturing of medical devices. In Japan, ISO 13485 has been adopted as an ordinance on standards for manufacturing control and quality control of medical devices and in vitro diagnostics.

Safety management

Sometimes side effects not observed in the development stage come to light after the launch of a new drug. In accordance with Good Vigilance Practice (GVP) standards, Seikagaku conducts post-marketing pharmacovigilance activities involving promptly and appropriately collecting, evaluating, and sharing feedback information on the side effects of drugs prescribed at medical facilities. Through these activities, we prevent the expansion of side effects and promote safety assurance and appropriate use of new drugs.

Medical information collection and provision activities (Medical Science Liaison)

Seikagaku has established the Medical Science Liaison (MSL) Unit, which engages in activities to provide current scientific knowledge to external professionals independently from the marketing division. As scientific experts with sufficient ethical perspective, the MSL Unit contributes to medical progress by creating and disseminating medical evidence relating to disease information and products in the fields in which Seikagaku focuses, such as orthopedic disorders and ophthalmic diseases.

Quality Compliance Structure