Product Quality Review of the [18F]FDG radiopharmaceutical

Aims: A Product Quality Review (PQR) is an essential tool for analysing and verifying the consistency of established and validated production processes as well as the quality of the produced radiopharmaceuticals. In accordance with European GMP requirements, PQR must be performed annually, to confirm the consistency and suitability of existing processes and to identify opportunities to improve both the product and processes. This study aims to present the аnnual PQR for [18F]FDG radiopharmaceutical produced during the year 2024, at the University Institute for Positron Emission Tomography.
Methods: A retrospective study was performed on all [18F]FDG batches produced in 2024. The PQR covered: (i) number of manufactured and released batches; (ii) starting materials/consumables and their compliance with Abstracts EANM Innovation 2 (2026) 100027specification for starting materials; (iii) in process controls including decay-corrected radiochemical yield and bubble point test (BPT) results; (iv) quality control (QC) results of finished product and trending against final product specification (appearance, radionuclidic identity, pH, radiochemical purity/identity by TLC, residual solvents, radionuclidic purity, bacterial endotoxins and sterility); (v) out-of-specification (OOS) results and investigations; (vi) deviations; (vii) status of equipment qualification/calibration and preventive/corrective maintenance; (viii) complaints; and (ix) change control, including revised and newly introduced procedures.
Results: A total of 194 batches of [18F]FDG were produced; only one batch was not approved for injection, indicating that 99.5% was released. The yield decay corrected was 64% (ranging from 50–78%), and the filter integrity test results were in the range of 4.00–4.56, indicating that the manufacturing process was stable and met the defined acceptance criteria. A review of the quality control results showed stable performance throughout the whole year and they were closely distributed around the mean value, with no out-of-trend values. All batches released were in accordance with the finished product testing specification. One OOS event was recorded and, following laboratory investigation, the root cause was identified as operator error with appropriate follow-up actions. During the year, 15 deviations related to the [18F]FDG production process were opened, of which five were major, one critical and the others were minor. All were documented and closed in accordance with the deviation procedure. During 2024, no complaints were reported for [18F]FDG or associated services. The equipment used for production and quality control was routinely maintained and qualified. Through change control, four standard operating procedures (SOPs) were revised, and four SOPs were implemented during the year.
Conclusion: From the annual Product Quality Review of the finished product [18F]FDG radiopharmaceutical, it can be concluded that the production process is stable, consistent and GMP-compliant, ensuring that the finished product consistently meets the specifications for [18F]FDG solution for injection, as well as the incoming material complies with approved specifications for the quality of starting materials.
Keywords: PQR, GMP, radiopharmaceutical preparations, pharmaceutical quality system:

https://doi.org/10.1016/j.eanmi.2026.100074