What accreditation verifies the sterility and quality control of the therapeutic product's cell processing facility?
Good Manufacturing Practice (GMP) compliance or certification by a recognized international body.
Verifying the quality and safety of the actual therapeutic product requires examining the standards under which the cells are handled and prepared, separate from the surgical or administrative standards of the clinic itself. The most critical verification point for the sterility and quality control procedures in the cell processing laboratory is adherence to Good Manufacturing Practice (GMP). GMP compliance, or certification from an equivalent recognized international body that oversees the consistent and quality-controlled production of therapeutic agents, serves as the benchmark ensuring that the actual cells administered to the patient meet necessary safety and purity specifications.
