Implementation of Good Manufacturing Practice in small-volume production of [18F]FDG: a case report of performance measurements

Positron Emission Tomography has become increasingly relevant in clinical practice for diagnostic purposes. A major concern regarding radiopharmaceuticals in general is how quality requirements can be guaranteed in nuclear medicine departments or in cases where marketing authorization has been granted. This article focuses on issues related to the small-volume preparation of radiopharmaceuticals by a Research Institute after Good Manufacturing Practice implementation.