ABSTRACT
PET radiopharmaceuticals have played an important role in diagnostics and been further evolved towards precision medicine with the rise of theragnostics in the early 2000s. However, compared to conventional drugs, radioactive and time-related decay properties of PET radiopharmaceuticals attached to various radionuclides with a specific half-life result in significant manufacturing challenges and thus the in-hospital small-scale preparation of PET radiopharmaceutical provides a potential solution for delivering such special medicines at affordable cost. Because PET radiopharmaceuticals are commonly administered parenterally as a sterile injection, the aseptic production process under high-maintenance environmentally controlled cleanrooms usually results in high drug cost when produced by a large-scale commercial manufacturer. However, during these years, GMP-compliant quality systems have been requested to be implemented in hospital radiopharmacies, and this further causes considerable discussion concerning the rationality and appropriateness of such an implementation. Thus, this chapter aims to provide an overview for the environmental control in a cleanroom and further comparison between the above different PIC/GMP guides for PET radiopharmaceutical production by commercial manufacturers and hospital radiopharmacies.
