Transforming an Academic Radiochemistry Facility for Positron Emission Tomography Drug cGMP Compliance

Mol Imaging Biol. 2020 Apr;22(2):256-264. doi: 10.1007/s11307-019-01395-6.

Abstract

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).

Keywords: Academic; Compliant; FDA; PET drugs; Transformation; cGMP.

MeSH terms

  • California
  • Cyclotrons
  • Drug Approval
  • Drug Industry / standards*
  • Facility Regulation and Control / standards*
  • Guideline Adherence*
  • Humans
  • Positron-Emission Tomography / standards*
  • Quality Control
  • Radiochemistry / methods*
  • Radiopharmaceuticals
  • United States
  • United States Food and Drug Administration
  • Universities

Substances

  • Radiopharmaceuticals