DUE JUNE 30, 2022: Standards Coordinating Body Seeks Comments on Chain of Identity Identifier Definitions and Requirements

Posted in :: 2022 Volume 2 :: Friday, June 17th, 2022

The Standards Coordinating Body (SCB) assembled a multi-stakeholder working group, including FACT, to develop proposed definitions and requirements for Chain of Identity (COI) identifiers titled, “Key Requirements and Definitions for Chain of Identity Identifier.” Standard definitions and requirements have become increasingly important as the number of players in the cellular therapy supply chain has increased and become more diverse. FACT strongly recommends its accredited organizations and inspectors review the draft and submit comments. Comments are due by June 30, 2022.

As SCB explains in the draft, COI identifiers are essential to demonstrating adequate control of biological material. FACT-accredited organizations have expressed concern about the challenges of implementing several identification systems at a single institution and how they pose risks of mix-ups. These definitions will hopefully lead to consistent use of COI identifiers and potentially allow the development of common COI identification systems for multiple cellular therapy products.

Please review the draft and submit your comments via the commenting template to Dawn Henke at dhenke@regenmedscb.org.

Read the draft Key Requirements and Definitions for Chain of Identity Identifier
Download the Commenting Template