Radiopharmaceutical good practices: Regulation between hospital and industry.

Front Nucl Med

Nantes-Angers Cancer Research Center CRCI2NA, University of Nantes, INSERM UMR1307, CNRS-ERL6075, Nantes, France.

Published: September 2022

Radiopharmaceutical practices are divided into large-scale industrial manufacturing and small-scale "in-house" hospital radiopharmacy unit. The recent evolution of nuclear medicine involves deep consequences in this ever-present regulatory state, and hospital radiopharmacy units cannot be considered as contract manufacturing organizations (CMO). This review provides an updated status report of the official (and non-official) guidelines supporting the regulations required to meet hospital and industry common radiopharmaceutical manufacturing standards to facilitate the current and future innovative radiopharmaceutical development.

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Source
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC11440975PMC
http://dx.doi.org/10.3389/fnume.2022.990330DOI Listing

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