Regulatory Issues: Down to the Bare Bones - Engineered Bone: Tissue Engineering Intelligence Unit - page 215

Figure 2. Schematic summarizing the risk management/assessment for a GMP/GLP and/or certified
procedure.
Contaminating Agents
Risk of bacterial, viral, micoplasmic, fungal or yeast contamination during the manufactur-
ing process and in the intermediate/final products must be reasonably excluded. It is responsi-
bility of the manufacturer to grant the purity and safety of the final product.
In the U.S.A. the FDA requires testing of blood samples from allogeneic donors of he-
matopoietic stem cells in order to prevent the transmission of communicable diseases. The
implementation of regulatory procedures, paragraph A-2, states: “...For peripheral blood