FACT-JACIE International Standards for Hematopoietic Cellular Therapy Product Collection, Processing, and Administration, Ninth Edition
The accreditation standards co-published by FACT and JACIE for programmes that collect, process and administer hematopoietic cellular therapy products. They cover hematopoietic progenitor cells from any source, nucleated and mononuclear cells, immune effector cells, and genetically modified cells, across the clinical, collection, processing and quality-management domains. The Ninth Edition was published on 29 October 2025 with its accreditation manual.
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Scope & applicability
Hematopoietic cell transplantation and cellular therapy programmes — their clinical units, collection facilities and processing laboratories — seeking FACT or JACIE accreditation. Programmes that give immune effector cell therapy without transplantation use the separate FACT-JACIE Immune Effector Cell Standards (Third Edition, published alongside).
Key requirements
- A quality management programme spanning the clinical unit, collection facility and processing laboratory
- Separate requirement sets for the clinical programme, the collection facility and the processing laboratory, which accreditation inspects together
- Documented training and competency for staff in each facility
- Inspection by FACT or JACIE inspectors against the standards, using the accreditation manual's evidence expectations
Implementation tips
- Treat the accreditation manual as part of the standard: it states the intent of each standard and the evidence inspectors will ask to see
Revision notes
The Ninth Edition HCT Standards and Third Edition IEC Standards were co-published by FACT and JACIE on 29 October 2025 after more than 1,000 public comments, which were published with the committee's decisions and rationale for the first time.
Where this control fails
live FDA enforcementLive FDA recalls SPEQ maps to this standard’s topics — a SPEQ interpretation, not an FDA classification.
FACT-JACIE HCT Standards, 9th ed.: frequently asked questions
Quick answers to common questions about FACT-JACIE HCT Standards, 9th ed..
What is FACT-JACIE HCT Standards, 9th ed.?
FACT-JACIE HCT Standards, 9th ed. — FACT-JACIE International Standards for Hematopoietic Cellular Therapy Product Collection, Processing, and Administration, Ninth Edition — is a standard issued by the Foundation for the Accreditation of Cellular Therapy. The accreditation standards co-published by FACT and JACIE for programmes that collect, process and administer hematopoietic cellular therapy products. They cover hematopoietic progenitor cells from any source, nucleated and mononuclear cells, immune effector cells, and genetically modified cells, across the clinical, collection, processing and quality-management domains. The Ninth Edition was published on 29 October 2025 with its accreditation manual.
Who does FACT-JACIE HCT Standards, 9th ed. apply to?
Hematopoietic cell transplantation and cellular therapy programmes — their clinical units, collection facilities and processing laboratories — seeking FACT or JACIE accreditation. Programmes that give immune effector cell therapy without transplantation use the separate FACT-JACIE Immune Effector Cell Standards (Third Edition, published alongside).
What are the key requirements of FACT-JACIE HCT Standards, 9th ed.?
FACT-JACIE HCT Standards, 9th ed. requires, among other things: A quality management programme spanning the clinical unit, collection facility and processing laboratory; Separate requirement sets for the clinical programme, the collection facility and the processing laboratory, which accreditation inspects together; Documented training and competency for staff in each facility; Inspection by FACT or JACIE inspectors against the standards, using the accreditation manual's evidence expectations.
When was FACT-JACIE HCT Standards, 9th ed. last updated?
The current version of FACT-JACIE HCT Standards, 9th ed. dates from October 2025. The Ninth Edition HCT Standards and Third Edition IEC Standards were co-published by FACT and JACIE on 29 October 2025 after more than 1,000 public comments, which were published with the committee's decisions and rationale for the first time.
This standard in practice
Recall domain is a SPEQ mapping of this standard’s topics, not an FDA classification.