Japan Regenerative Medicine Quality Standards Council releases quality management white papers

The Japan Regenerative Medicine Quality Standards Council (JRQ) has released two white papers outlining standardized procedures for quality management in the regenerative medicine and health food sectors.

The first white paper focuses on initial response containment when deviations occur. It emphasizes separating the identification of the impact scope, the suspension of use, and additional verification steps. By distinguishing between these actions, organizations can better manage risks such as overlooking necessary targets or unnecessarily expanding the scope of an incident. It also recommends separating the roles of those performing fact-finding from those deciding on the suspension or continuation of operations.

The second white paper addresses the verification of completed corrective actions. It outlines a framework for managing response deadlines, implementation evidence, and recurrence prevention evaluations. The council advises that organizations should not treat the start of a corrective action and its completion as a single record. Instead, they should maintain distinct documentation for deadlines, actual evidence of work performed (such as training or material replacement), and long-term observation to ensure that recurrence prevention measures are truly effective.