cGTP requirements govern the methods used in, and the facilities and controls used for, the manufacture of HCT/Ps in a way that prevents the introduction, transmission, or spread of communicable diseases by HCT/Ps (§ 1271.150(a)).4 Manufacture, as defined in
§ 1271.3(e), means, but is not limited to, any or all steps in the recovery, processing, storage, labeling, packaging or distribution of any human cell or tissue, and the screening or testing of the cell or tissue donor. Under § 1271.145, you must recover, process, store, label, package, and distribute HCT/Ps, and screen and test cell and tissue donors, in a way that prevents the introduction, transmission, or spread of communicable diseases. Under § 1271.150(a), communicable diseases include, but are not limited to, those transmitted by viruses, bacteria, fungi, parasites, and transmissible spongiform encephalopathy agents.
What Are Core CGTP Requirements?
• Core CGTP requirements (§ 1271.150(b)) are those requirements that directly relate to preventing the introduction, transmission, or spread of communicable disease by HCT/Ps. The core CGTP requirements include requirements for:
• Facilities (§ 1271.190(a) and (b));
• Environmental control (§ 1271.195(a));
• Equipment (§ 1271.200(a));
• Supplies and reagents (§ 1271.210(a) and (b));
• Recovery (§ 1271.215);
• Processing and process controls (§ 1271.220);
• Labeling controls (§ 1271.250(a) and (b));
• Storage (§1271.260(a) through (d));
• Receipt, predistribution shipment, and distribution of an HCT/P (§ 1271.265(a) through (d)); and
• Donor eligibility determinations, donor screening, and donor testing
(§§ 1271.50, 1271.75, 1271.80, and 1271.85).
Other CGTP requirements discussed in this guidance support the core CGTP requirements (e.g., the required records management system in § 1271.270(b)). Although we have identified core CGTP requirements, you must follow all CGTP requirements (§ 1271.150(a).