Teijin Pharma has built a system to ensure compliance throughout every stage of research, development, production, and post-marketing
Organization to Ensure Compliance
Independent Compliance Division
A provider of pharmaceuticals and medical devices deals in products with direct impact on patients' lives. As such, it must take responsibility for safety and quality in its products and services. Safety and quality take first priority at Teijin Pharma. This commitment to safety is reflected in the positioning of the Compliance Division as an entity independent of the individual process lines and under the direct control of the company president.
Besides conforming to strict quality control requirements such as Good Manufacturing Practice (GMP) and ISO at each process of R&D and production, the Compliance Division at Teijin Pharma assists in quality control activities for individual processes, as well as for auditing and assessment operations. The Compliance Division also ensures compliance in the post-marketing phase by taking charge of post-marketing surveillance and the collection and control of safety- or quality-related information, including data on adverse drug reactions and complaints on quality.
A system to ensure compliance through cooperation inside and outside the company
Compliance with laws, regulations, and the public standards of regulatory authorities (including the Ministry of Health, Labour and Welfare and the Ministry of Economy, Trade and Industry) is merely the minimum requirement for the manufacturers and authorized marketers of Pharmaceuticals and Medical Devices. Teijin Pharma has set up stricter corporate rules and management systems to establish a more robust compliance system for the fulfillment of patient expectations.
Teijin Pharma imposes strict corporate rules to assure reliability and runs an internal audit system covering every division of the company. It also undergoes audits and receives assistance from the Teijin Group to ensure full conformance with the Teijin Group Ethical Rules, Teijin Group Product Liability & Quality Assurance Rules, the Teijin Group Risk Management Rules, and the like. Through these steps, Teijin Pharma has established an airtight system to assure the reliability of products and services in the Pharmaceuticals and Home Healthcare businesses.
Post-marketing safety control
Of the many categories of mass-produced products, pharmaceuticals and medical devices must comply with the some of the most rigorous standards and guidelines for safety of use, as product with direct impacts on patients' lives. Strict requirements on quality, efficacy, and safety must be met to obtain marketing approval from the Japanese Ministry of Health, Labour and Welfare.
And in light of the limited history of clinical use of the products approved through the application process, the authorized marketers of the products are required to continue post-marketing surveillance and monitoring to ensure safe and proper use.
The authorized marketers of these products shoulder tremendous responsibility for safety even after the products are released. Inside and outside of the company, Teijin Pharma has constructed a system to integrate safety control information such as post-marketing data on adverse drug reactions and complaints on quality from medical institutions in Japan and partner companies and regulatory authorities domestically and overseas. Within this information-integrating system, the company incorporates a mechanism to take prompt and appropriate actions.
Quality control activities at production sites
Even after a mass-production system in full compliance with quality standards is established, quality control activities are consistently implemented and renewed at the production sites. The quality control activities at Teijin Pharma's production sites are ISO certified and conform to the requirements of Good Manufacturing Practice (GMP). Our manufacturing organizations are also consistently introducing and improving new production technologies and equipment to establish quality design systems at the field level.
Teijin Pharma also adheres faithfully to the "quality first" principle in its systems for checking the following production process. Pharmaceutical and medical device products are checked by organizations independent from the entities responsible for production. The quality control systems in place at production sites for medical devices rigorously test the unit components and performance of the assembled items, as well as the "aging" of components by preconditioning operations. Processes are also standardized at the production sites to maintain production quality while reducing the total costs arising from manufacturing activities.
