For the reliable and safe production and delivery of high-quality radiopharmaceutical products, our production sites maintain production environments in conformity with the latest Good Manufacturing Practice (GMP).
In addition to production sites in Chiba (Sodegaura) and Hyogo (Sanda) for SPECT products, we established PET laboratories across the country for our entry into the PET business.
All of our employees demonstrate professionalism and are devoted day and night to ensuring excellent quality, keeping in mind the maintenance and enhancement of a clean environment for pharmaceutical production as well as strict environmental and safety controls adequate for RI-handling facilities.
Safety management system for product quality
Nihon Medi-Physics designates one of the corporate functions specifically to be engaged in supervising product quality and safety according to relevant regulations such as the Pharmaceutical Affairs Law, GQP (Ministerial Ordinance on standards for Quality Assurance for Drugs, Quasi-drugs, Cosmetics and Medical Devices), and GVP (Ministerial Ordinance Related to Standards for Post-Marketing Safety Management of Drugs, Quasi-drugs, Cosmetics and Medical Devices).
Radiation safety management system
For an enterprise involved in the special field of nuclear medicine, proper and strict control of radiation is the foremost priority. Nihon Medi-Physics has established a department responsible for RI management, where dedicated staff members including radiation protection supervisors having special knowledge and experience are assigned. To secure the safety of workers and surrounding areas against radiation, the RI management department controls exposure to workers and provides safety controls for work rooms and other environments. As an example of these measures, radioactivity inside and outside the facility is measured once a month to monitor the condition of radioisotope contamination in the production site of radiopharmaceuticals. Nihon Medi-Physics establishes and applies in-house standards that are stricter than the management criteria of regulations. We periodically implement necessary safety measures and examine work processes and environmental conditions to conduct safety radiation management on a daily basis.