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.
To ensure quality assurance, pharmacovigilance, and quality auditing, Santen has established the Quality Compliance Division under the direct control of the President and CEO. As experts in activities to build highly reliable quality compliance systems, the members of the Quality Compliance Division inspire all other employees to work hard to enhance the reliability of the Santen brand, and ultimately, to help improve the quality of life (QOL) of 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 50 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