Safety and Quality Control Protocols
Quality control (QC) in a radiopharmacy is rigorous because the final product must be both chemically pure and radiologically accurate. Every batch of medicine undergoes testing for radiochemical purity—ensuring the radioactive atom is properly attached to the targeting molecule—and radionuclidic purity, which checks for unwanted radioactive contaminants.
Because of the short shelf-life, these tests must be performed rapidly before the dose is released to the clinic. Automated systems are increasingly used to perform these checks to minimize radiation exposure to the pharmacy staff. Documentation is exhaustive; every vial must have a complete "batch record" that tracks the medicine from the initial raw isotope to the moment it is injected into the patient.
