Radiopharmaceutical Production and Quality Control

With the development of shorter-lived, organ-specific radiopharmaceuticals, much of the manufacture and quality control of these products have shifted from commercial manufactures to individual nuclear medicine laboratories. Recognizing this fact, the Nuclear Regulatory Commission (NRC) is encouraging quality assurance by proposing that an authorized physician may permit technicians and other paramedical personnel to perform the preparation and quality control testing of radiopharmaceuticals... Cohen has categorized pharmaceutical controls into chemical, biological, and physical. Figure 1 is a diagram of these controls. In each control a degree of purity is implied and is often determined by comparison to standard