Guidance for Current Good Tissue Practice
Current Good Tissue Practices
Current Good Tissue Practices (CGTP) are governing methods and practices outlined by the US Food and Drug Administration (FDA). US-based tissue manufacturers are required to follow the core set of CGTP in line with their work.
Tissue manufacturers play an important role in identifying tissue cells from donors and recovering the best tissues for use in regenerative medicine techniques. Consequently, these companies are accountable to their clients’ health and should carefully implement the FDA tissue regulations.
The main aim of CGTP is to regulate the environment, equipment, and personnel of the manufacturing process of human cells, tissues, and cellular and tissue-based products (HCT/Ps) to stop the introduction and spread of contagious disease.
The FDA’s list of core good tissue practices for companies making and supplying HCT/Ps includes requirements about manufacturing facilities, donors, equipment, and personnel.
Facility Standards
All facilities involved in producing HCT/Ps must be sized and located in accordance with FDA regulations. Ensuring a clean, safe, and efficiently-run manufacturing process can improve the final quality of the product.¹ Facilities must be undamaged, well-lit, and ventilated to minimize the risk of disease transmission.
Environmental Controls
The facility’s environment plays an important role in the likelihood of disease transmission. The regulated environmental factors include temperature, humidity, ventilation, and appropriate aseptic processing.
Facilities are required to monitor environmental conditions if there is a reasonable risk of environmental factors contaminating biological products or materials.² Some facilities monitor viable and non-viable particulates in the air, positive pressure levels, and surface sanitation.
Donor Screening
Tissue regulation involves rigorously screening donors who offer their tissue for recovery and processing purposes. All companies producing HCT/Ps must comply with FDA written procedures, which are meant to protect future clients’ safety.
At BioStem Technologies, our donors are screened and consenting individuals. We test our donors for communicable diseases or disease agents (RCDADs), and individuals are eligible donors if their tests indicate no clinical evidence or risk factors.
Supplies and Reagents Validation
Supplies and reagents must be properly validated by the company using them or the company supplying these tools. This required process checks that supplies and reagents will not increase the danger of disease introduction and transmission through a known method.³
Safe Recovery Procedures
The FDA regulates tissue recovery for regenerative medicine purposes in two ways. Tissue manufacturing companies can be registered with the FDA or use donor-recovered tissues to comply with FDA safe recovery procedures.
Proper tissue identification practice is necessary to secure the right cells and tissues at the time of recovery.
Effective and safe tissue recovery can lead to innovative medical advances, like using perinatal tissue in regenerative therapies.
Processing and Process Control
In order for a cell to divide successfully, the cell must first complete DNA replication correctly.⁴ Effective processing, in turn, requires successful cell division.
The processing aspect of HCT/P manufacturing, including preparation, sterilization, and storage preservation, must take measures to prevent disease introduction and spread.
Manufacturers can promote safe processing by properly labeling, storing, and inventorying their materials and products.