Published in:
Open Access 01-04-2020 | Positron Emission Tomography | Special Topic
Transforming an Academic Radiochemistry Facility for Positron Emission Tomography Drug cGMP Compliance
Published in: Molecular Imaging and Biology | Issue 2/2020
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In light of the United States Food and Drug Administration (FDA) requirement of 21 CFR 212 current Good Manufacturing Practice (cGMP) for FDA-approved position emission tomography (PET) drugs, the University of California Los Angeles (UCLA) Biomedical Cyclotron (BMC) transformed from a pre-cGMP era academic cyclotron and radiochemistry facility to a current cGMP-compliant PET drug manufacturer. In this article, we share the financial and regulatory compliance aspects of the “transformation” required to develop a sustainable quality system to support the production of two PET drugs under Abbreviated New Drug Applications (ANDAs).