Good tissue practice

Good Tissue Practice (GTP) refers to the regulations and standards set by regulatory bodies to ensure the safety and quality of human cells, tissues, and cellular and tissue-based products (HCT/Ps). These practices are designed to prevent the introduction, transmission, and spread of communicable diseases by HCT/Ps. The principles of GTP cover all aspects of the HCT/P lifecycle, including donation, procurement, testing, processing, preservation, storage, and distribution.

Overview

Good Tissue Practice is a critical component of the regulatory framework for HCT/Ps. It complements Good Manufacturing Practice (GMP) and Good Clinical Practice (GCP), which are also essential for ensuring the safety and efficacy of medical products. GTP focuses specifically on the unique aspects of handling human tissues and cells, which can be sources of infectious diseases if not properly managed.

Regulatory Background

In the United States, the Food and Drug Administration (FDA) is the primary regulatory body overseeing the implementation of GTP. The FDA's regulations for GTP are outlined in 21 CFR Part 1271, which establishes the criteria for donor eligibility, as well as the methods for procuring, processing, storing, and distributing HCT/Ps. Similar regulatory frameworks exist in other jurisdictions, such as the European Union's directives on human tissues and cells, which aim to ensure a high level of human health protection.

Key Components of Good Tissue Practice

Good Tissue Practice encompasses several key components to ensure the safety and quality of HCT/Ps:

Donor Screening and Testing

Donor screening and testing are critical to reducing the risk of transmitting communicable diseases through HCT/Ps. This involves reviewing the donor's medical history, conducting physical examinations, and performing laboratory tests for infectious agents.

Procurement

Procurement refers to the process of obtaining cells and tissues from donors. It must be conducted in a manner that minimizes contamination and ensures the safety of both the donor and the recipient.

Processing and Preservation

Processing involves manipulating the tissue or cells to make them suitable for their intended use, while preservation involves maintaining their viability and function until they are used. Both processes must be carried out under controlled conditions to prevent contamination and degradation.

Storage and Distribution

Proper storage conditions must be maintained to preserve the quality and safety of HCT/Ps until they are used. Distribution practices must ensure that HCT/Ps are transported in a manner that maintains their integrity and traceability.

Compliance and Enforcement

Compliance with GTP is mandatory for establishments that handle HCT/Ps. Regulatory bodies, such as the FDA, conduct inspections to ensure adherence to these practices. Non-compliance can result in enforcement actions, including product recalls, seizure of products, and penalties.

Conclusion

Good Tissue Practice is essential for ensuring the safety and quality of human cells, tissues, and cellular and tissue-based products. By adhering to these practices, healthcare providers and manufacturers can minimize the risk of transmitting communicable diseases and ensure that HCT/Ps are safe for their intended use.