Safety & Quality
All amniotic tissue used in the formulation of our products is voluntarily donated by expectant mothers undergoing cesarean sections. Per PHSA requirements, all prospective donors and tissue are stringently tested and screened for disease. Our amniotic membrane grafts are formulated in an FDA-registered tissue bank, which is an accredited member of the American Association of Tissue Banks and adheres to the Current Good Tissue Practices (cGTP) established and enforced by the U.S. Food and Drug Administration (FDA). A few of these practices include:
• Registering the tissue bank with the FDA.
• Maintaining proper records and documentation.
• Adhering to good tissue practices associated with the production of our products.
• Following strict FDA requirements for donor tissue screening.
What are cGTPs?
CGTP requirements govern the methods used in, and the facilities and controls used for, the manufacture of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) in a way that prevents the introduction, transmission, or spread of communicable diseases by HCT/Ps. Communicable diseases include, but are not limited to, those transmitted by viruses, bacteria, fungi, parasites, and transmissible spongiform encephalopathy agents. A formal system of controls is necessary to fulfill core CGTP requirements that cover facilities, environmental control, equipment, supplies and reagents, recovery, processing and process controls, labeling controls, storage, receipt, predistribution shipment, distribution, donor eligibility determinations, donor screening, and donor testing. Read more about FDA’s cGTP requirements here.