FDA 21 CFR Part 606
The 21 CFR Part 606 regulation establishes CGMP requirements for blood and blood components. Its aim is to ensure quality in blood banks and other organizations that process blood products. Its guidelines help them appropriately manage records, reports, labeling, equipment, facilities, personnel and controls for production, processes and laboratories. It is enforced by the Center for Biologics Evaluation and Research (CBER), a division of the U.S. Food and Drug Administration (FDA). Process automation simplifies compliance with Part 606 and gets blood and related products to patients sooner.