ESTABLISHING GLOBAL STANDARDS IN CELLULAR THERAPIES
The FACT Standards promote improvement and progress in cellular therapy. Meeting these requirements demonstrates a commitment to controlling every aspect that impacts the quality of products and therapeutic care. With regular updates through the collaboration of the most knowledgeable minds in cellular therapy, the depth and breadth of these Standards are unmatched. These international requirements instill confidence in cellular therapy products from FACT accredited organizations around the world.
About the FACT Standards
The Standards are the cornerstone of the FACT accreditation program. Believing that quality care can only be achieved if both clinical and laboratory issues are effectively addressed, the FACT Standards are the only set of requirements that include both clinical and laboratory practices. The Standards currently apply to Hematopoietic Progenitor Cells (HPC) and Therapeutic Cells (TC) obtained from bone marrow, peripheral blood, and umbilical cord blood.
FACT Standards are evidence-based requirements set by international teams of world-renowned experts vested in the improvement and progress of cellular therapy. Standards are developed by consensus within committees consisting of knowledgeable clinicians, scientists, technologists, and quality experts that span the entire continuum of cell manufacturing. International leaders in cellular therapy programs, cord blood banks, and registries serve on the Standards Development Committees. Liaison representation from consumers and regulatory bodies are consulted throughout the development process. This results in detailed, comprehensive Standards that address every aspect of cell manufacturing and administration that impacts the quality of products and therapeutic care.
The Standards are based upon published medical evidence whenever possible. When published data is not available, requirements are based upon accepted scientific theory. The development process includes a period for public review and comment, legal review, and approval by the FACT Board of Directors.
International Standards for Cellular Therapy Product Collection, Processing, and Administration
These Standards apply to cellular therapy programs that collect, process, or administer cells isolated from bone marrow or peripheral blood, including organizations that provide support for such services. They also apply to programs that administer cells derived from cord blood.
Obtain Cellular Therapy Standards
International Standards for Cord Blood Collection, Processing, and Release for Administration
These Standards apply to cord blood banks that perform cord blood donor management and collection, processing, testing, cryopreservation, storage, listing, search, selection, reservation, release, and distribution. Obtain Cord Blood Standards