JRQ releases white papers on quality standards and information disclosure

The Japan Regenerative Medicine Quality Standards Council (JRQ) has released two white papers providing neutral guidance on quality management and information transparency within the regenerative medicine and health food sectors.

The first white paper focuses on information disclosure and update procedures. It outlines methods for distinguishing between public-facing documents (such as organizational charts and quality standards) and internal management records. It emphasizes the importance of maintaining consistent revision histories, ensuring that version numbers, publication dates, and reasons for changes are clearly documented to support accountability and prevent confusion during inquiries.

The second white paper addresses conformity verification procedures, specifically regarding the preparation of audit and application materials. It advises practitioners to clearly separate application summaries from actual verification records to ensure rigorous assessment. Key operational focuses include defining roles for various stages of review, documenting specific requirements for document revisions, and establishing a traceable link between different records—such as processing, testing, and storage—to allow third parties to accurately interpret quality information.