GTP refers to FDA requirements that are meant to ensure the safety of human cell, tissue, and cellular and tissue based products (HCT/Ps) by preventing the introduction, transmission, and spread of communicable disease. GTP requirements can be found in 21 CFR Parts 1270 and 1271.
Part 1270 contains requirements for determining the suitability of a donor of human tissue intended for transplantation, as well as requirements for written procedures, record keeping, and inspection. Part 1271 contains comprehensive requirements for HCT/P establishments including:
■ “Establishment Registration and Listing for Manufacturers of Human Cellular and Tissue-Based Products,” (Subpart B);
■ “Suitability Determination for Donors of Human Cellular and Tissue-Based Products,” (Subpart C); and
■ “Current Good Tissue Practice for Human Cell, Tissue, and Cellular and Tissue-Based Establishments;
Inspection and Enforcement,” (Subparts C and D).
