26/27 January 2021
GMP News |
FDA's CBER Updates Q&A List Concerning the Current Good Tissue Practice (CGTP) 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. You may find the Q&A list at
http://www.fda.gov/cber/rules/gtpq&a.htm |