Guideline on current good radiopharmacy practice (cGRPP) for the small-scale preparation of radiopharmaceuticals

TLDR

This guideline outlines current good radiopharmacy practice for small‑scale preparation of radiopharmaceuticals, reflecting the European Association of Nuclear Medicine’s Radiopharmacy Committee. The guideline follows EU GMP standards, targets non‑commercial sites such as hospital radiopharmacies and research PET centres, and is organized into sections covering general aspects, small‑scale preparation with licensed generators and kits, and complex preparations from non‑licensed materials requiring purification and sterile filtration. The guideline aims to assist radiopharmacies in preparing safe diagnostic and therapeutic SSRPs for human administration.

Abstract

Abstract This guideline on current good radiopharmacy practice (cGRPP) for small-scale preparation of radiopharmaceuticals represents the view of the Radiopharmacy Committee of the European Association of Nuclear Medicine (EANM). The guideline is laid out in the format of the EU Good Manufacturing Practice (GMP) guidelines as defined in EudraLex volume 4. It is intended for non-commercial sites such as hospital radiopharmacies, nuclear medicine departments, research PET centres and in general any healthcare establishments. In the first section, general aspects which are applicable to all levels of operations are discussed. The second section discusses the preparation of small-scale radiopharmaceuticals (SSRP) using licensed generators and kits. Finally, the third section goes into the more complex preparation of SSRP from non-licensed starting materials, often requiring a purification step and sterile filtration. The intention is that the guideline will assist radiopharmacies in the preparation of diagnostic and therapeutic SSRP’s safe for human administration.