Alertness of in-process controls: feedback on two production errors

Context
An analytical control by UV/Raman (QCRx^®) is in place since 2008 in the chemotherapy reconstitution unit (CRU). This control, although efficient, has some limits (poor recognition of antibodies, impossible control of syringes, etc) which requires a double visual control. In order to further secure the production of chemotherapies (CT), the CRU was equipped with the DrugCam^® digital video system since May 2021.

Objectives
The objective of this work was to highlight the advantage of combining in-process control by Drugcam^® with control by QCRx^®.

Material and method
The software programs used were: Chimio^® and Drugcam^®. Analytical assays were performed by QCRx^®. Two situations were selected because of their severity (impact on the patient).
Case 1
An initial error generated by the Chimio^® program, a modification of the lot number of the active substance on the manufacturing sheet (MS), resulted causing the edition of a non-conforming MS of oxaliplatin 120 mg (the expected volume was 24 mL whereas 40 mL was edited).
The production was performed using the wrong volume of 40 mL, transmitted through the Chimio/Drugcam interface. All in-process steps were validated by Drugcam^®. The QCRx^® analysis revealed a recovery rate (RR) of 158.2%. In view of this result, the complete video was viewed: a poor homogenization was incriminated because all the steps were judged to be conform by Drugcam^®, leading to the pharmaceutical liberation.

Case 2
A bag of cisplatin 72 mg was produced : the Drugcam® in-process control did not detect any error, but the QCRx^® analysis with a TR of 71% required the pharmacist to view the control video. This step identified a handling error during fabrication: 22 mL taken from the bag itself and not from the cisplatin vial. The preparation was refused and then re-made.

Discussion – Conclusion
Corrective measures were put in place: checking the dose/volume ratio during MS modifications, viewing the entire video if analytical results are not compliant. A correct in-process control by Drugcam^® should not decreases alertness of the whole pharmaceutical team, especially if the analytical control is not compliant.
The possibility to combine these 2 methods appears to be a major advantage in order to secure the production of CT.

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