5PSQ-111 Risk analysis of advanced therapy medical products (ATMPs) circuits within a university hospital

<h3>Background and Importance</h3> The diversity of Advanced Therapy Medicinal Products (ATMPs), together with their high cost and regulatory requirements, necessitate the establishment of complex pharmaceutical circuits. Their deployment within our hospital requires the collaboration of many partners, located at different sites. The complexity of ATMP circuits and the large number of people involved increase the risk of errors during the process. One of the most widely used methods to identify and manage potential risks in a process is FMEA (Failure Modes and Effects Analysis). <h3>Aim and Objectives</h3> We aimed to map and analyse all risks inherent to our ATMP circuits in order to propose corrective and preventive actions (CAPAs) for unacceptable risks, following the FMEA method. <h3>Material and Methods</h3> Multidisciplinary working groups evaluated each stage of the circuit using an experienced-base risk assessment, identifying known or potential risks, their causes and effects. The criticality of each risk was scored out of 125, according to its frequency, severity and detectability, each coded from 1 to 5 following institutional recommendations. Risks were categorised according to their score: low (&lt; 10), moderate (10–20) and critical (&gt; 20). Critical risks, deemed unacceptable, led to the formulation of CAPAs. <h3>Results</h3> A total of 291 potential risks were identified across 7 stages, from prescription to administration. Of these, 86% were considered acceptable (low and moderate risks), while 14% were deemed critical, with reconstitution being the most critical step. Of the critical risks, 90% were attributed to our facility, 7% to the manufacturer and 3% to our cryopreservation partner. Human factors accounted for 50% of these risks, organisational and logistical for 25%, and technical for 25%. The main consequence affected patients (58%). CAPAs for critical risks required human resources in 62% of cases, technical resources in 28% and laboratory coordination in 10%. <h3>Conclusion and Relevance</h3> This analysis showed that our circuits are generally secure, as the majority of the risks identified were acceptable. The main sources of risk included the absence of a dedicated team within the pharmacy, inexperience, increasing workload, and the diversity of ATMPs. An evaluation of the implementation and effectiveness of CAPAs is planned as part of an ongoing effort to improve the quality of our circuits. <h3>References and/or Acknowledgements</h3> <h3>Conflict of Interest</h3> No conflict of interest