Foundation for the Accreditation of Cellular Therapy
Co-publisher with JACIE of the FACT-JACIE International Standards for hematopoietic cellular therapy and immune effector cells, and the voluntary accreditation arm of ASTCT and ISCT.
What this page does not claim
SPEQ curates and cross-references these bodies. It is not affiliated with, accredited by, or endorsed by any of them, and a count of decoded standards is a measure of SPEQ’s coverage, not of a body’s importance.
WHAT FACT COVERS
The Foundation for the Accreditation of Cellular Therapy (FACT) was formed in 1995 and incorporated as a nonprofit in 1996. It is the voluntary inspection and accreditation arm of two professional societies, the American Society for Transplantation and Cellular Therapy (ASTCT) and the International Society for Cell & Gene Therapy (ISCT). It writes consensus standards for cellular therapy, through international committees with public and legal review, and accredits programmes against them. With JACIE, the Joint Accreditation Committee of ISCT and EBMT, it co-publishes the FACT-JACIE International Standards for Hematopoietic Cellular Therapy Product Collection, Processing, and Administration (Ninth Edition) and the FACT-JACIE International Standards for Immune Effector Cells (Third Edition), both published on 29 October 2025. FACT also issues standards for immune effector cells given in community clinical settings.
WHAT FACT PUBLISHES
- 01FACT-JACIE International Standards for Hematopoietic Cellular Therapy, Ninth Edition, with its accreditation manual
- 02FACT-JACIE International Standards for Immune Effector Cells, Third Edition
- 03FACT Standards for Immune Effector Cells in the Community Clinical Setting
- 04Summaries of changes, self-assessment tools, document-submission requirements, and training and competency forms for each edition
HOW ITS REQUIREMENTS BITE
Accreditation is voluntary. FACT inspectors, who are volunteer peers, inspect a programme's clinical unit, collection facility and processing laboratory against the standards, and FACT inspects programmes around the world. In Europe the same standards are applied through JACIE. The accreditation manual for each edition states the intent of each standard and the evidence inspectors expect. FACT standards carry no legal force of their own, so regulatory obligations such as FDA's 21 CFR 1271 apply alongside them.
What practitioners get wrong
- Choose the right standard first. Programmes that perform transplantation use the HCT standards even for their immune effector cell work; programmes that give only immune effector cells use the IEC standards.
- The accreditation manual is where evidence expectations live. Preparing from the standards alone misses what inspectors will ask to see.
- The programme is inspected as one unit, so hand-offs between clinical, collection and processing, such as identity, labelling and records, are where gaps show.
- For the Ninth Edition FACT and JACIE published the public comments, which numbered more than 1,000, with the committee's decisions and rationale for the first time. That record is a useful guide to how a standard should be read.
WHERE IT SITS INTERNATIONALLY
FACT and JACIE publish one set of standards, so accreditation means the same thing in North America and Europe. The standards sit alongside, and do not replace, national regulation of cell and tissue products such as FDA's 21 CFR 1271. They overlap with AABB's cellular therapy standards and with the GMP rules that apply when a cellular product is manufactured as a licensed biologic.
FACT STANDARDS SPEQ DECODES · 1
DISCIPLINES IN FACT’S REMIT
FACT: frequently asked questions
Reference answers on Foundation for the Accreditation of Cellular Therapy’s mandate, what it publishes, and how its requirements acquire force.
What is the current edition of the FACT-JACIE hematopoietic cellular therapy standards?
The Ninth Edition of the FACT-JACIE International Standards for Hematopoietic Cellular Therapy Product Collection, Processing, and Administration, published on 29 October 2025 with its accreditation manual. The Third Edition of the Immune Effector Cell Standards was published at the same time.
Who runs FACT?
FACT was formed in 1995 and incorporated as a nonprofit in 1996 as the voluntary inspection and accreditation arm of ASTCT and ISCT. It co-publishes its standards with JACIE.
Is FACT accreditation mandatory?
No. FACT accreditation is voluntary. Regulatory requirements for cell and tissue products, such as FDA's 21 CFR 1271, apply independently.