Objective: Radiopharmacy is a high-risk hospital pharmacy carried out in a complex regulatory environment. Adopting an audit culture is a priority issue to secure the radiopharmaceutical drug circuit. The objective of the study is to demonstrate the value of cross auditing, a hybrid between internal and third party auditing.

Method: A 125-item evaluation tool applying to the entire radiopharmacy activity was designed. Two radiopharmacies were audited internally and then a cross-audit was organized between the two units.

Results: For one of the units, 12 items were rated differently during the two audits. Four of the ten non-conformities that were not observed during the internal audit were rated as critical by the radiopharmacist auditor. For the second radiopharmacy, 15 items were rated differently, two of which were rated as critical.

Conclusion: Personal opinion may unintentionally influence a reasoning, but the independence of the auditor during cross auditing is a guarantee of objectivity. It is an alternative to internal audits which have become routine and less efficient and unlike third party audits, the auditor is familiar with the constraints and concerns of the field. The interest of this approach goes beyond the simple evaluation of non-conformities. Cross auditing encourages the sharing of experience and know-how between professionals in the same field. It creates a dynamic collaboration between establishments and contributes to the individual and collective improvement of the safety of the radiopharmaceutical drug circuit.

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http://dx.doi.org/10.1016/j.pharma.2023.08.004DOI Listing

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