# Risk Management in Good Manufacturing Practice (GMP) Radiopharmaceutical Preparations
## 3 Results
\begin{table}
\begin{tabular}{c c c c c c} \hline \hline \multicolumn{6}{c}{**Failure Mode and Effect Analysis (FMEA)**} \\ \hline
**Main Process** & **Activity** & **Ipoteticals Risks** & **Effects** & **Type of Damage** & **SxOxD** \\ \hline \multirow{4}{*}{Analysis LAL test} & Device faulty or not calibrated & Production delay or loss of production & Sustainability & 1 \\ \cline{2-5}  & Value out of range in sample measurement & OOS final product & Product safety & 4 \\ \hline \multirow{4}{*}{GC residual solvent analysis} & Error in the standards preparation & Production delay & Sustainability & 2 \\ \cline{2-5}  & Device faulty or not calibrated & Production delay or loss of production & Sustainability & 1 \\ \cline{2-5}  & Value out of range in sample measurement & OOS final product & product safety & 4 \\ \hline \multirow{4}{*}{Chemical and radiochemical purity analysis by HPLC} & Error in the standards preparation & Production delay or loss of production & Sustainability & 4 \\ \cline{2-5}  & Device faulty or not calibrated & Production delay or loss of production & Sustainability & 2 \\ \cline{2-5}  & Value out of range in sample measurement & OOS final product & Product safety & 4 \\ \hline \multirow{4}{*}{CQ} & Error in the standards preparation & Production delay & Sustainability & 1 \\ \cline{2-5}  & Device faulty or not calibrated & Production delay or loss of production & Sustainability & 2 \\ \cline{2-5}  & Value out of range in sample measurement & OOS final product & Product safety & 2 \\ \hline \multirow{4}{*}{Radionuclide purity: gamma spectrometry analysis} & Device faulty or not calibrated & Production delay or loss of production & Sustainability & 4 \\ \cline{2-5}  & Value out of range in sample measurement & OOS final product & Product safety & 2 \\ \hline \multirow{4}{*}{Sterility control} & Loss of samples, shipment not carried out & GMP deviation & Product safety & 2 \\ \cline{2-5}  & Value out of range in sample measurement & GMP deviation & Product safety & 3 \\ \cline{2-5}  & Value out of range in sample measurement & GMP deviation & Product safety & 1 \\ \cline{2-5}  & Value out of range in sample measurement & GMP deviation & Product safety & 2 \\ \hline \multirow{4}{*}{Microbiological control} & Value out of range in sample measurement & OOS final product & Product safety & 2 \\ \cline{2-5}  & Microbiological control & Device faulty or not calibrated (oven and SAS) & GMP deviation & Product safety & 1 \\ \cline{2-5}  & \multirow{4}{*}{Preparation for shipment} & Suitcases not available & Inability to ship & Sustainability & 8 \\ \cline{2-5}  & & Shipping documents not available & Shipping delay & Sustainability & 1 \\ \cline{2-5}  & & Mixup of the shielded container and Suitcases & Customer dissatisfaction & Product safety & 2 \\ \cline{2-5}  & Delivery to the carrier & Courier not available & Inability to ship & Sustainability & 2 \\ \hline \multirow{2}{*}{Batch Release} & \multirow{2}{*}{BR verification} & Human error in data verification & release of non-compliant product & Product safety & 3 \\ \cline{2-5}  & & verification & product & safety & 3 \\ \hline \hline \end{tabular}
\end{table} 
Table 8: _Cont._The most critical activities (productivity, reliability, non-conformities) were analyzed as suggested in Chapter 1 of the EUGMP guidelines Volume 4 for a period of 21 months of activity of the production site after restart. The results of these analyses are summarized in the following figures. The first analysis concerns the productivity of the site evaluated through the number of productions/months. Figure 3 shows that over those 21 months, the productivity went from 2 productions per month to 27 productions per month. Regarding reliability evaluation, the collected data were grouped into 17 slots of 20 productions, and for each slot, the reliability percentage value was calculated using the following formula: Reliability = scheduled lots/released lots \(\times\) 100.