Chapter 19: Quality Considerations in Radiopharmaceuticals Check Access

Radiopharmaceuticals are widely used for the diagnosis and therapy of disease. Similarly to conventional drugs, radiopharmaceuticals are subjected to quality control (QC) tests before administration to patients. Nevertheless, due to the presence of radionuclides, radiopharmaceuticals undergo additional QC testing. High quality diagnostic radiopharmaceuticals are required for accurate diagnosis and administration of optimal treatment and dose to patients. High quality therapeutic radiopharmaceuticals are necessary to minimize extra radiation burden to patients. To obtain high purity radiopharmaceuticals, it is imperative to guarantee quality at every step of the entire process, from production to release. This chapter describes (a) good manufacturing practices in radiopharmaceuticals, (b) QC tests – physicochemical and biological – and (c) practical considerations in quality assurance of radiopharmaceuticals.