Comment from Scott Brubaker
AnonymousSupportIndividual
Summary: The commenter supports the issuance of the guidance but suggests including references to CGTP requirements in 21 CFR part 1271. They specifically recommend referencing CBER's 2011 guidance and donor eligibility requirements to ensure comprehensive manufacturing controls.
Thank you for issuing this guidance. Was it intentional to omit any reference to the CGTPs in 21 CFR part 1271 regulations? HCT/Ps regulated as biological products are regulated under sections 351 and 361 of the PHS Act and the FD&C Act, and certain CGTP requirements would require additional manufacturing practices. Manufacturing controls could include up to eleven CGTP requirements that would not be partly or completely covered by a corresponding CGMP regulation requiring the same practice. It may be helpful to include parts of, or reference in this guidance, CBER's CGTP final guidance for manufacturers of HCT/Ps (dated December 2011) where this is explained very well in section III. at listings E. and F. At a minimum and as applicable, a reminder regarding an expectation to follow all donor eligibility requirements in 21 CFR part 1271 subpart C may prove helpful. Thank you!