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Health authorities and regulators are increasingly looking for much higher traceability levels during the manufacture of parenteral medicines. The most common processes and technologies applied to achieve compliance are now reaching their technical limitations. As such new approaches are needed to deliver the traceability requirements, traceability at the individual container level could become very important to drive patient safety by preventing product mix-up. There are other strong business drivers for uniquely coded containers. These include improved batch visibility and accountability whilst simplifying investigation work in case of potential deviations during fill and finish operations. This reduces risk and can limit the direct financial impact of missed revenue or drug shortages.
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Core Team Leader
Tod Urquhart has more than ten years’ experience working in the field of product serialization and traceability.
He has extensive knowledge of planning, managing, and delivering cross-functional serialization projects for pharmaceutical regulatory compliance and product interaction and traceability. Previous projects include working with Pfizer, GSK, Lucozade, Red Bull, and Danone.
Tod is currently the Core Team Lead for the Stevanato Group project, working on Primary Container Traceability [PCT].
The project covers a range of areas from developing new printing processes through systems integration to commercial modelling and creating a common standard for the Pharmaceutical industry.