On July 5, 2007 the US Food & Drug Administration's Center for Biologics Evaluation and Research (CBER) announced an update of its comprehensive Q&A list on the GCTP Final Rule.

The list addresses a very broad range of issues - from "What is current good tissue practice?" to "Does FDA require that HCT/Ps be sterile? - and unexpected questions like "Are FDA HCT/P establishment inspections conducted during regular business hours?"

This Q&A document provides a good overview on basic CGTP requirements and gives a direct reference to the provisions.

Therefore, it is of high value for those who are dealing with tissues in an FDA environment.
Those who would like to get an introduction into the most critical topics concerning tissues and CBER's point-of-view will also benefit significantly from reading this document.

You may find the Q&A list at http://www.fda.gov/cber/rules/gtpq&a.htm
 
Author:
Dr Ulrich Herber
On behalf of the European Compliance Academy (ECA)