Human tissue allografts are growing rapidly in surgery. To safeguard the quality, efficacy and safety of the muscoloskeletal grafts, it is mandatory to introduce suitable methods in the manufacturing processes to minimize pathogen contaminants while preserving chemical/physical and biological properties.

Despite the stringent safety measures commonly applied and the use of bactericide substances, the risk of trasmission of infections is not eliminated.

For this reason the American Food and Drug Administration (FDA) and the European Health Authorities released new regulations introducing pharmaceutical requirements for human tissue processing In November 2004 F.D.A. released the Current Good Tissue Practice (cGTP) that regulates the methods, the plants , the controls and the quality to be used in the human tissue processing.

While European Health Authorities released 2004/23/CE and 2006/86/CE Directives on the quality and safety requirements for donations, processing , storage and distribution of human tissues as well as traceability and pharmacovigilance.