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Interim Cellular Therapy Standards

Changes to a current edition of Standards are reserved for only those that are urgent in nature or frequently requested with compelling reasons.

2 February 2017 - changes to 6th edition

FACT and JACIE have published interim standards for the sixth edition FACT-JACIE International Standards for Hematopoietic Cellular Therapy Collection, Processing, and Administration.
The interim standards are intended to promote quality in administration of immune effector cell products, such as chimeric antigen receptor T cells (CAR-T cells), natural killer cells, virus-specific T cells, therapeutic cellular vaccines, and others.
The requirements primarily highlight unique aspects of administration and toxicities of immune effector cells.
For more information, click here.

21 August 2013- changes to 5th edition

FACT and JACIE published version 5.3 of the International Standards for Cellular Therapy Product Collection, Processing, and Administration and its accompanying Cellular Therapy Accreditation Manual on August 21, 2013 to reflect FDA requirements for donor eligibility documentation.
Specifically, this version removes the requirements for donor eligibility documentation for autologous donors in Appendix III.

The updated Accreditation Manual also includes updated guidance on DMSO lot-to-lot qualification for Standard D4.13.2.

This version of the Standards becomes effective on September 20, 2013.


31 October 2012 - changes to 5th edition

FACT and JACIE have published interim standards in the fifth edition FACT-JACIE International Standards for Cellular Therapy Product Collection, Processing, and Administration pertaining to the following topics:
  • Red cell antibody screening (B6.4.2, CM6.3.10 and C6.4.2)
  • Donor eligibility versus suitability (B3.4.3.3, D6.1.7, and D6.1.8)
  • General clarification (B4.10.5)
These interim standards were incorporated into the 5th edition in response to feedback received from transplant programs and related organizations. Because the changes relaxed a requirement, clarified regulatory requirements, or reinforced the original intent, no public comment period was opened. The interim standards will be effective after 30 days, or November 30, 2012.

The changes made are summarized in Appendix IV of the updated Standards.


Updated Guidance Information Published in Cellular Therapy Manual
FACT, in partnership with JACIE, has updated the Cellular Therapy Accreditation Manual to proactively share precedent-setting decisions with inspectors and programs so that everyone is able to accurately apply the Standards in the same manner as the Accreditation Committees. This information helps the intent of the Standards to be consistently applied by all programs and subsequently assessed by inspectors.

The Cellular Therapy Manual has been updated to explain the different areas of ASHI/EFI accreditation (Cellular Therapy Standard B2.4.6). In addition, the Cellular Therapy Accreditation Manual has additional information regarding the following:
  • Access to Marrow Collection Facilities and physicians trained and competent in marrow collection (B3.3.4)
  • HLA typing (B6.4.10)
  • Safe administration of preparative regimens (B7.4)
  • Representative samples (D6.1.2.2)
See current versions of Standards and Manual below.
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Eoin McGrath,
2 Feb 2017, 01:46
Ċ
Eoin McGrath,
2 Feb 2017, 01:47
Ċ
Eoin McGrath,
2 Feb 2017, 01:46