Quality Compliance

The Santen Group established the Quality Compliance Division directly under the president to supervise quality assurance, safety vigilance and auditing with the aim of promoting compliance activities in order to assure corporate compliance including product quality, safety and post marketing responses.

Assurance of Product Life-Cycle Reliability

Quality Principle Policy

Santen Group will contribute to the well-being of society by satisfying established regulations, specifications, and standards of quality. By taking advantage of today's leading-edge technology, Santen will ensure high quality of our drug products, medical devices and nutritional supplements, and will provide services according to our Quality Principle Policy.

The Santen Group seeks to assure the reliability of the product life-cycles of pharmaceuticals according to our "Quality Principle Policy."

All Santen employees working for production and quality control receive education, on appointment and regularly, on quality control, standard operating procedures (SOP), and other topics useful for maintaining product quality and reliability.

Click on the following link to find out more about our assurance of product life cycle reliability.

Prevention of Medical Mistakes

Drug errors may not only prevent patients on such drugs from obtaining the anticipated effect but may also cause the onset of unanticipated side effects. To prevent such medical mistakes, the Santen Group provides clearly identifiable packaging and information labels on containers, in an effort to reduce the workload of medical staff required to identify drugs, as well as to ensure accuracy in handling drugs.

For example, for eye drops available in various concentrations with the same components, we provide information on the concentration on the shrink labels that cover the eye drop containers as well as at the top of the cap in different colors.

Examples of eye drop containers

Measures against Counterfeit Medicines and Other Quality Compliance Measures

To prevent accidental confusion between domestic prescription medicines, ensure their traceability, and enhance the efficiency of distribution, Santen will print bar codes that indicate not only the product code but also the serial number and the expiration date on all product boxes and packages for transportation by the end of March 2021. We promote measures for Good Distribution Practice (GDP) to ensure a higher level of quality compliance by maintaining and appropriately managing medicine quality during storage and transportation, and taking measures against counterfeit medicines.

Efforts to Obtain Information Relating to the Safety of Pharmaceuticals

While pharmaceuticals are useful for treatment, they may adversely affect health, for example, due to side effects. For this reason, manufacturers of pharmaceuticals and medical devices in Japan, including Santen, are required by law to report cases of suspected adverse events to the Ministry of Health, Labour and Welfare (MHLW).

The Santen Group has established and documented internal procedures to be taken when we receive information relating to safety, including adverse event information, from patients or healthcare professionals. The procedures require us to report the information immediately and appropriately to our department of safety management, to enable the information to be shared among related departments within the company. Based on the procedures, we have built a globally effective reliability assurance system, desirable also from the perspective of pharmacovigilance. We think it is crucial for all of our officers and employees to understand our responsibilities and the actions we should take, so we provide them with adequate training.

Click on the following link to find out more about our Global Quality Compliance.

Product Recall

If any issues are found regarding the safety, efficacy, quality, labeling or other respects of our products, the Santen Group immediately reports such issues to the authorities, provide the information to medical institutions, and recall applicable products based on our quality assurance system. In FY2017, there were no cases of product recall.