GMP Aspects of Medical Radionuclide Products

Session Organizer:
Sally W. Schwarz, Washington University School of Medicine, United States

This session will cover the regulatory requirements for Good Manufacturing Practice(GMP) and quality control (QC) of medical radionuclide production for human use. It will include therapeutic radionuclides such as Sr-89 Chloride (Metastron) used for palliation of bone pain and Ra-223 Chloride (Zofigo) for prostate cancer, and production of PET radionuclides, formulated into PET radiopharmaceuticals for diagnostic imaging. Additionally PET and SPECT radionuclide generators such as Ge-68/Ga-68, Sr-82/Rb-82 and Mo-99/Tc-99 will be discussed. The GMP requirements will be discussed in light of the new 21 Code of Federal Regulations (CFR) Part 212 for PET drugs, and under Part 211 for production of SPECT radionuclides, as well as requirements for alpha emitting radionuclides.

INVITED PAPERS

Quality Control of Reactor Produced Radioisotopes at MURR
Cathy Sue Cutler, University of Missouri, Research Reactor Center, United States