The EU Falsified Medicine Directive (EUFMD), which requires serialisation and bar codes on the smallest saleable units of drugs, is set to be implemented from 2019 in Europe.
Similarly, certain serialisation requirements are set to come into force in the US next year, under the US Drug Supply Chain Security Act (DSCSA), part of the Drug Quality and Security Act (DSQA) signed into law in 2013.
As such, Cork, Ireland-based manufacturing software firm Zenith has partnered with SEA – a pharmaceutical packaging vision system producer based near Milan, Italy – in order to offer what the firms say will be a full, non-disruptive service for drugmakers to manage these regulatory expectations.
“Together both Zenith Technologies and SEA Vision can provide not only leading serialisation software, but also on the ground integration, ongoing technical support and training at a local level, thanks to Zenith Technologies' global network of expert engineers,” Jim Lehane, Director at Zenith Technologies told Outsourcing-Pharma.
“This ensures that pharmaceutical manufacturing and packaging companies have the necessary support to deal with the continuous challenge that serialization will bring, ensuring seamless compliance with the new regulations without impacting productivity and product supply.”
The offering will see Zenith integrate and deliver ongoing technical support for SEA’s track-and-trace software, which generates randomised serial numbers compliant with local regulations.
“Thanks to its modular structure based on plugin and external services - that can be integrated in time without affecting the application core - SEA Vision's solution is scalable, completely configurable and has a low impact on validation processes,” Marco Baietti, Commercial Director at SEA, told us.
The partnership comes as a number of third-parties invest in technologies to help support pharma firms ahead of the regulatory deadlines. Recently contract development and manufacturing organisation (CDMO) Recipharm invested €40m ($45m) into such technology, while other suppliers such as TraceLink has also been advancing its own serialisation capabilities.