Risk Management in Good Manufacturing Practice (GMP) Radiopharmaceutical Preparations

Risk assessment and management during the entire production process of a radiophar- maceutical are pivotal factors in ensuring drug safety and quality. A methodology of quality risk assessment has been performed by integrating the advice reported in Eudralex, ICHQ, and ISO 9001, and its validity has been evaluated by applying it to real data collected in 21 months of activities of 18F-FDG production at Officina Farmaceutica, CNR-Pisa (Italy) to confirm whether the critical aspects that previously have been identified in the quality risk assessment were effective. The analysis of the results of the real data matched the hypotheses obtained from the model, and in particular, the most critical aspects were those related to human resources and staff organization with regard to management risk. Regarding the production process, the model of operational risk had predicted, as later confirmed by real data, that the most critical phase could be the synthesis and dispensing of the radiopharmaceuticals. So, the proposed method could be used by other similar radiopharmaceuti- cal production sites to identify the critical phases of the production process and to act to improve performance and prevent failure in the entire cycle of radiopharmaceutical products.