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Interim Cellular Therapy Standards Published

posted 23 Aug 2013, 06:11 by Eoin McGrath   [ updated 9 Jul 2015, 01:06 ]
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.
Eoin McGrath,
23 Aug 2013, 06:11