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8th edition of FACT-JACIE Standards

See Key Dates and other information on the 8th edition.

The FACT-JACIE International Standards for Hematopoietic Cellular Therapy Product Collection, Processing, and Administration, eighth edition includes hematopoietic progenitor cells (HPCs), nucleated cells or mononuclear cells from any hematopoietic tissue source collected for therapeutic use other than as HPCs, immune effector cells (IECs), and genetically modified cells.

This the sixth collaboration to publish comprehensive quality-based Standards in cellular therapy between the Foundation for the Accreditation of Cellular Therapy (FACT) and JACIE, the Joint Accreditation Committee of ISCT and EBMT of the European Society for Blood and Marrow Transplantation (EBMT). FACT was founded in 1996 by the American Society for Transplantation and Cellular Therapy (ASTCT) and the International Society for Cell and Gene Therapy (ISCT), published the first edition of Hematopoietic Cell Standards that year, and initiated the North American inspection and accreditation program based on these Standards in 1997. JACIE was established in 1999, adopted the first edition of FACT Standards, and jointly reviewed the second edition in 2002. Subsequent editions of Standards have been jointly developed, approved, and published by FACT and JACIE.

The objective of the FACT-JACIE International Standards for Hematopoietic Cellular Therapy Product Collection, Processing, and Administration is to promote quality medical and laboratory practice in hematopoietic progenitor cell transplantation and therapies using hematopoieticderived cellular products. FACT-JACIE Standards are unique in depth and breadth, being applicable to all phases of cell collection, processing, storage, transportation, and administration, and to all phases of clinical application including standard of care therapies and products, products administered under regulatory-approved clinical trials, and licensed (or other regulatory approval) products.

 

Note - the Inspection Checklist will be available by mid-June 2021