FACT-JACIE 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 respective FACT and JACIE Boards.
The 6th edition of the Standards were published on 1 March 2015. Edition 6.01 was published on 2 February 2017 to incorporate standards for administration of immune effector cells. Edition 7 was published on the 1st of March, 2018, and implementation will begin the 1st of June, 2018.