FACT Standards Development Activities
FACT Common Standards, Second Edition Nearing Publication
The Second Edition FACT Common Standards for Cellular Therapies will be published on March 15, 2019. Once published, the updated Standards, summary of changes, and crosswalks will be available on the FACT website for reference, and printed copies of the Standards will be available for purchase from the FACT store.
The major objective of the FACT Common Standards for Cellular Therapies is to promote quality medical and laboratory practice in a broad range of cellular therapies. These Standards represent basic principles of quality in cellular therapy that can be applied to any cell source or therapeutic application, and are intended to be used throughout product development and clinical trials. In early stage product development and early phase clinical trials, these Standards provide the quality management infrastructure to facilitate patient and data accrual to advance the therapy.
NetCord-FACT International Cord Blood Standards, Seventh Edition Available for Public Review and Comment
The NetCord-FACT Standards Committee completed its initial review of the draft Seventh Edition NetCord-FACT International Standards for Cord Blood Collection, Banking, and Release for Administration.
The draft Standards and accompanying Accreditation Manual are published for inspection and public comment for a 90-day period. Comments will be accepted through April 1, 2019.
These Standards apply to all phases of cord blood collection, banking, and release for administration, including donor management, collection, processing, testing, cryopreservation, storage, listing, search, selection, reservation, release, and distribution to clinical programs.
Description and Instructions for Review and Comment
Draft NetCord-FACT Cord Blood Standards
Draft NetCord-FACT Accreditation Manual
Comments regarding the draft Seventh Edition NetCord-FACT Cord Blood Standards can be submitted by accessing the Comment Form. Comments will be accepted through April 1, 2019.
Standards Committee to Initiate FACT-JACIE International Hematopoietic Cellular Therapy Standards and FACT Immune Effector Standards Development
FACT is creating the Steering Committee and Subcommittees that will develop the Eighth Edition FACT-JACIE International Standards for Hematopoietic Cellular Therapy Product Collection, Processing, and Administration and the Second Edition FACT Immune Effector Cell Standards.
In addition to the existing subcommittees (clinical, collection, processing, and quality management), an immune effector cell subcommittee will be added to the Hematopoietic Cellular Therapy Standards development process to ensure consistency between the two sets of Standards.
Standards development will begin this summer, with the first draft scheduled for public comment in April 2020.
