Concept of Quality Compliance
Maintenance of Quality and Safety of Santen's Products, to Establish Its Brand
Since pharmaceuticals have a critical influence on human health and life, manufacturers must observe rigorous quality control standards stipulated in various regulations, including GMP(*1), GVP(*2), GPSP(*3), GQP(*4), GLP(*5), and GCP(*6). Simply observing these regulations, however, is not sufficient to maintain Santen's brand value and reputation. To continue supplying pharmaceuticals that meet changing user demand amid rapid social changes and the progress of science and technology, all Santen employees must make concerted efforts to earn customers' trust in Santen's products and services. Employees engaged in R&D, production, marketing, and many other tasks, should work together to enhance the reliability of Santen's products in terms of quality, efficacy and safety, and the quality of its services, including after-sales care.
For this purpose, Santen has set up a Quality Compliance system consisting of Quality Assurance and Safety Vigilance departments, in order to ensure quality assurance and safety vigilance following R&D, development, manufacture, and launch. All employees participate in the activities to establish and promote a high level quality management system, thereby contributing to enhancing the QOL (Quality of Life) for patients and their loved ones.
- Good Manufacturing Practice (Standards for Manufacturing Control and Quality Control for Drugs and Quasi-drugs)
- Good Vigilance Practice (Standards for Post-Marketing Safety Control of Medicinal Products, Quasi-Medicinal Products, Cosmetics and Medical Devices)
- Good Post-marketing Study Practice (Standards for Conducting Post-Marketing Studies on Drugs)
- Good Quality Practice (Standards for Quality Assurance for Drugs, Quasi-drugs, Cosmetics and Medical Devices)
- Good Laboratory Practice (Standards for Conducting Nonclinical Safety Studies on Drugs)
- Good Clinical Practice (Standards for the Conduct of Clinical Trials of Medicinal Products)
Global Quality Compliance
To Supply Safe and Reliable Pharmaceuticals to Patients Worldwide
Santen's products are used in more than 60 countries throughout the world. To continue to supply safe and reliable products to patients in many countries, where social and economic systems can differ, Santen has established a global quality compliance system. To guarantee the brand's reliability, this system adopts two approaches: quality assurance and pharmacovigilance.
Global Quality Compliance System
Quality Assurance Initiatives
Global Quality Management Committee (GQMC) meetings, consisting of members from heads of Quality Assurance Division and QA functional group leaders, are held on a regular basis in order to set Global policies for Quality Assurance/ audits, and create various standards.
Safety Vigilance Initiatives
Safety Vigilance activities are thoroughly carried in order to give safety and stability to the patients who use Santen products, as well as their loved ones.
By using a Global Database to integrate and manage safety information collected from around the world, evaluating the safety measures needed for appropriate use, and providing information to the medical facilities, Safety Vigilance members endeavor to promote appropriate product use and minimize the safety risk for patients.