GTP
Good Tissue Practice
What a definition is not
A definition is SPEQ’s plain-language decode of how a term is used in practice, cited to the documents that define it. It is a practitioner reference, not legal or regulatory advice, it does not replace the definition in the source, and where a regulator’s wording differs the regulator’s wording governs.
Good Tissue Practice is the set of US requirements governing the manufacture of human cells, tissues, and cellular and tissue-based products (HCT/Ps) — covering donor eligibility, and the methods, facilities, and controls used in recovery, processing, storage, labeling, packaging, and distribution. Its overriding purpose is to prevent the introduction, transmission, and spread of communicable disease through these products. It is a distinct regulatory scheme for HCT/Ps, separate from — though sometimes overlapping with — drug and device GMP.
GTP is preventive-control logic applied to biological materials of human origin: donor screening and testing, contamination and cross-contamination control, and traceability from donor to recipient are its central concerns. The core control (CGTP) provisions focus specifically on those aspects most likely to affect the risk of communicable-disease transmission.
Some HCT/Ps are regulated solely under this tissue framework, while others also meet the definition of a drug, device, or biologic and carry those additional requirements — determining which regime(s) apply is a threshold question for any tissue product.
- —US requirements for human cells, tissues, and HCT/Ps
- —Primary goal: prevent transmission of communicable disease
- —Covers donor eligibility, recovery, processing, storage, labeling, distribution
- —Distinct scheme; some products also fall under drug/device/biologic rules
US Current Good Tissue Practice, 21 CFR Part 1271 (donor eligibility, Subpart C; CGTP, Subpart D).
Frequently asked questions
What does GTP stand for?
GTP stands for Good Tissue Practice.
What is GTP?
Good Tissue Practice is the set of US requirements governing the manufacture of human cells, tissues, and cellular and tissue-based products (HCT/Ps) — covering donor eligibility, and the methods, facilities, and controls used in recovery, processing, storage, labeling, packaging, and distribution. Its overriding purpose is to prevent the introduction, transmission, and spread of communicable disease through these products. It is a distinct regulatory scheme for HCT/Ps, separate from — though sometimes overlapping with — drug and device GMP.
Which regulations cover GTP?
US Current Good Tissue Practice, 21 CFR Part 1271 (donor eligibility, Subpart C; CGTP, Subpart D).