Overview and Background
cGTP stands for “current Good Tissue Practice.”
It is a type of manufacturing control standard for products involving human cells and tissues, and can be considered a GMP-equivalent for tissues by analogy to pharmaceutical GMP.
cGTP is a regulation administered by the FDA’s Center for Biologics Evaluation and Research (CBER) in the United States, and applies to the handling of human cells and tissues, and human cells, tissues, and cellular and tissue-based products (HCT/Ps). The background is the growing need—along with the spread of transplantation and cell therapy—to ensure rigorous safety management so that infectious diseases are not transmitted via these human-derived products.
For example, risks include transmission of disease from donor to recipient in organ/tissue transplantation, and bacterial or fungal contamination during cell culture. cGTP was established as a systematic standard to prevent such issues.
In the U.S., the FDA issued the final rule in 2004, and cGTP compliance has been mandatory for human cells and tissues collected on or after May 2005.
cGTP applies broadly—to tissue grafts such as bone, skin, cornea, heart valves, and cartilage; to stem cells and cord blood; and even to sperm, oocytes, and embryos used in IVF.
However, items governed under separate regulatory frameworks (e.g., organ transplantation and blood for transfusion) fall outside cGTP. In addition, even for cells or tissues, if processing exceeds certain bounds (i.e., is “more than minimally manipulated”), they may be regulated as drugs or devices under other standards (e.g., GMP) rather than cGTP.
In other words, cGTP is the handling standard primarily for human cells and tissues with relatively low degrees of processing.
Main Requirements and Standards
In a word, cGTP requirements focus on controls to prevent the transmission of communicable diseases.
Specifically, standards are set across the entire chain—from donor recovery (collection) of human cells/tissues through to implantation in the patient—to ensure cleanliness and safety.
Key elements include:
Donor Eligibility Determination
To prevent transmission of infections from donors, donor health status and medical history are evaluated, and blood tests confirm absence of infections such as HIV and hepatitis viruses.
This donor screening and donor testing is a core cGTP requirement. Cells/tissues from donors determined ineligible must not be used.
Facility, Equipment, and Environmental Controls
Facilities handling cells and tissues maintain clean areas that enable aseptic operations—for example, cleanrooms and biological safety cabinets—and perform routine environmental monitoring (microbiological testing).
Verification and maintenance of instruments and equipment are also critical; deficiencies can cause microbial contamination or mix-ups, so periodic inspection and calibration are required.
Control of Raw Materials and Reagents
For items that contact cells/tissues—such as culture media, storage solutions, reagents, and containers/packaging—quality control and traceability are ensured. Where sterility or endotoxin limits apply, appropriately tested materials are used, and each lot is recorded.
Process Control (Recovery, Processing, Storage, Transport)
Cell/tissue recovery is performed aseptically, and after collection materials are promptly stored/transported under appropriate temperature conditions. Processing steps (washing, concentration, refrigerated storage, cryopreservation, etc.) follow defined procedures that preserve tissue function and prevent contamination.
Labeling is strictly controlled to indicate contents, donor information, expiry, etc., preventing misuse. During storage, temperature and inventory are tightly managed; during transport, appropriate conditions (e.g., cold chain) are maintained.
Quality Control and Documentation
Testing and checkpoints are implemented at each step to confirm there are no anomalies—for example, sterility testing and measurement of cell counts/viability.
Written standard procedures are prepared for all steps, and records are kept for each operation. If a problem occurs, root-cause investigation is conducted, and processes for Corrective Actions—such as stopping or discarding affected lots and assessing impacts on other products derived from the same donor—are defined.
These cGTP core requirements are detailed in FDA regulations [21 CFR 1271 Subparts C and D].
Put simply, the requirements come down to ensuring cleanliness and safety at every stage involving human cells and tissues, minimizing the risk of disease transmission.
cGTP has become a globally essential foundation for the safety of cellular and tissue products.
Significance and Benefits of Compliance/Certification
For organizations handling cells/tissues (banks and manufacturing facilities), cGTP compliance is both an ethical responsibility and a legal requirement.
In the U.S., manufacturing or marketing HCT/Ps without cGTP compliance violates FDA law (the Public Health Service Act) and is subject to strict penalties. Because this directly affects patient safety, regulation is stringent.
Conversely, demonstrating cGTP compliance serves as evidence of excellence in quality and safety. For example, U.S. cell/tissue banks can supplement FDA inspections with third-party accreditations—such as AABB—to demonstrate that their facilities meet international cGTP-level standards.
Such certifications build trust among users (hospitals and pharmaceutical companies) and confer business advantages.
Foremost among the benefits of cGTP compliance is protecting patients and end recipients.
By achieving the goal of preventing donor-derived infectious disease transmission, patients receiving transplants or cell therapy avoid unnecessary infection risks. In the past, untested organs/tissues led to transmission of hepatitis C or HIV; rigorous application of cGTP helps avoid such events.
This also strengthens trust in healthcare and supports the safe spread of cellular and tissue therapies.
Facilities compliant with cGTP are also better positioned for international collaboration and business.
Regenerative medicine and cell therapies often operate globally; when exchanging cellular materials with foreign partners, whether the counterpart meets cGTP is a key criterion.
cGTP compliance provides assurance that “cells from this bank can be used safely,” facilitating international cooperation and partnerships. It also aids relations with regulators: rigorous cGTP adherence tends to yield favorable inspection outcomes and smoother reviews during new product submissions.
In sum, cGTP compliance not only contributes to patient safety and quality but also enhances the credibility of related organizations and supports international expansion.
Impact of Certification on Products, Services, and Consumers
As a standard centered on healthcare, cGTP’s benefits directly reach patients and users of medical services.
For example, cellular products for regenerative medicine prepared in cGTP-compliant culture facilities have extremely low risks of contamination with microbes or viruses. Patients can derive maximal therapeutic benefit while reducing secondary concerns such as therapy-associated infections.
In tissue transplantation (bone, skin, cornea, etc.), grafts supplied by cGTP-compliant tissue banks carry documented donor testing and appropriate processing, assuring safety for recipients. This can improve transplant success rates and reduce postoperative complications.
Providers also benefit from handling cGTP-compliant cells/tissues.
Physicians and hospitals can focus on care by sourcing safe materials from trusted banks, reducing the likelihood of unanticipated infection incidents. For pharmaceutical companies, partnering with cGTP-compliant suppliers for cell-derived vaccine or therapeutic raw materials lowers product quality risks.
This raises the overall standard of care, benefiting both patients and healthcare providers.
From the general public’s perspective, the term “cGTP” may be unfamiliar. However, amid recent news about the safety of regenerative medicine or problems such as unauthorized provision by cord blood banks, society is increasingly concerned about whether only properly managed cells/tissues are used in medicine.
If cGTP-certified institutions take the lead in providing safe cellular therapies, a climate of confidence will grow and more people can receive advanced care with peace of mind. In this sense, cGTP underpins patients’ rights and safety and contributes to consumers by enabling higher-quality medical services.
Relevant International Bodies and Regulators
Although cGTP is primarily a U.S. FDA concept, its principles are shared internationally. In the U.S., FDA/CBER administers cGTP under the Public Health Service Act (PHSA), conducting facility inspections and issuing enforcement or corrective actions for violations.
Among private organizations, AABB (Association for the Advancement of Blood & Biotherapies) and FACT (Foundation for the Accreditation of Cellular Therapy) offer international accreditation programs. AABB, originally a blood banking organization, has expanded into cellular therapy, accrediting cord blood banks and cell processing facilities worldwide to its standards.
FACT accredits facilities in areas such as hematopoietic stem cell transplantation; these third parties complement regulators by promoting cGTP-like standards. In addition, the WHO issues guidance for cellular and tissue therapies and supports regulators through training.
Overall, with the FDA at the center, national authorities and international bodies are collaborating to advance global safety oversight (cGTP) for human cells and tissues.