Three Plant System
To Ensure Continuous Access to Safe Treatments Worldwide
Santen’s products have been supplied to not only the Japanese market, but also markets in over 60 countries.
To fulfill our responsibility to manufacture quality pharmaceuticals to patients worldwide, we have built a three-manufacturing bases system, comprising: the Noto Plant in Japan, one of the world’s largest plants in terms total production; the Shiga Product Supply Center, which supplies products to markets in and outside Japan; and the Suzhou Plant in China, which produces products for the rapidly growing Chinese market. Based on our three-plant manufacturing operation, Santen responds promptly to the needs of the global ophthalmic pharmaceutical market.
Santen’s Own Quality Criteria
Santen’s Strict Quality Criteria
To ensure that patients can continue to use Santen’s products without any safety concerns, Santen pays meticulous attention to the performance and design of its manufacturing facilities and factory lines. The Company has established its own quality criteria featuring higher quality levels than those required by relevant laws and regulations.
For instance, in producing eye drops we use water that has been purified for injections. For operators working in sterile environments and for visual inspectors, whose roles are particularly important, we have established a rigorous in-house qualification system. In this way, we thoroughly decrease the risk of errors throughout the production process, from selection of raw materials to the final stage of product testing.
Quality Compliance Activities
Dependable Brand Image, Created and Maintained by All Employees
Santen believes that quality control requirements must be fulfilled beyond the production lines. We have established our own system to ensure product reliability from the R&D stage to even after use of our products by patients. This system has been designed to guarantee efficacy, safety, and homogeneity (three principles) of pharmaceuticals on a global basis.
Under this system, the Quality Compliance Division works together with various divisions to confirm that our research, non-clinical studies and clinical trials are conducted pursuant to relevant regulations. Additionally they ensure that our production lines and quality control systems function properly, and that our MRs offer the proper information to ensure that patients use our products properly. To enhance the quality of life of patients who use our products, staff in these divisions jointly carry out thorough quality control and pharmacovigilance activities, as well as after sales care. Through these endeavors, Santen’s employees work to enhance both the quality of our products and corporate value.