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7th edition of FACT-JACIE Standards released

by Eoin McGrath

The seventh edition of the FACT-JACIE International Standards for Hematopoietic Cellular Therapy Product Collection, Processing, and Administration has been published on 1 March 2018 and becomes effective on June 1, 2018. 

See here for key dates for applications.

These Standards are designed to provide voluntary minimum guidelines for programs, facilities, and individuals performing cell transplantation and therapy or providing support services for such procedures. 

The Standards apply to all phases of collection, processing, storage, and administration of cellular therapy products, including various manipulations such as removal or enrichment of various cell populations, expansion of hematopoietic cell populations, and cryopreservation. 

For hematopoietic progenitor cells or therapeutic cells derived from umbilical cord and/or placental blood, these Standards apply only to the administration of the cellular product and the preparation of the product for administration, applying the clinical and/or processing standards as appropriate. These Standards do not apply to the collection, processing, or banking of umbilical cord and placental blood cells. Standards for these processes are found in the current edition of NetCord-FACT International Standards for Cord Blood Collection, Banking, and Release for Administration.

The documents below are:

  • Standards
  • Manual
  • Crosswalks (mapping of references in respective editions)
    • 6th - 7th
    • 7th - 6th
  • Summary of main changes
  • Side-by-side comparison 6.01-7 editions indicating changes in text.
  • Inspection checklist

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