Types of Accreditation for Cord Blood Banks
Within the United States, cord blood banks are subject to U.S. Food & Drug Administration (FDA) and state regulations. The FDA governs all aspects of cord blood preservation, including the collection, processing, storage, labeling, packaging, and distribution of cord blood stem cells. Within the United States, all cord blood banks must be registered with the FDA.
There are two different standards which can apply: cGTP (current Good Tissue Practices) and cGMP (current Good Manufacturing Practices)
- cGTP standards apply to the collection, processing, and storage of human cells, tissues, and cellular/tissue based products (HCT/Ps), and are regulated by the Center for Biologics Evaluation and Research. All U.S. cord blood banks must be compliant with cGTP standards.
- cGMP standards apply to the manufacturing of a product that is considered a drug, and the determination for whether or not a cord blood bank must be compliant with cGMP standards is based upon the nature of the product that a facility manufactures. Because cGTP standards are based upon cGMP standards, there are many similarities between the two systems.
In addition, there are a number of other agencies in the U.S. that accredit cord blood banks. The primary optional accrediting agency for cord blood banks is the AABB (formerly the American Association of Blood Banks). [Read more…]