Drugmakers will be required to give unique serialisation numbers and bar codes to the smallest saleable unit of pharmaceutical product later this year, as the second phase of the serialisation rules of the Drug Supply Chain Security Act (DSCSA) rolls out.
Meanwhile, from 2018 the EU Falsified Medicines Directive will require a unique serialisation number and bar code on every saleable unit of drug product intended for dispensation to a patient – a batch of 48 boxes of blister pack pills will need 48 different identifiers, for example, not just one for the lot.
“Industry is progressing very quickly in the US and EU toward supporting the serialization regulations,” Graham Clark, director of worldwide channels at TraceLink told in-Pharmatechnologist.com.
However, third-party manufacturers are falling behind, he said.
“TraceLink estimates that almost 50% of CMOs in the US and EU will not be ready in time to support their customers' serialization requirements. There are many reasons for this but it might account for up to 400 CMOs not being ready and could lead to a large restructuring of the CMO landscape.”
A number of service firms – including Recipharm, GEA and Zenith Technologies – have been upping their offerings in efforts to address the demand from CMOs, and TraceLink is no exception, recently becoming a reseller of Advanco’s ARC Suite packaging line management software.
“Advanco provides a site server that is independent of any Line Management System (LMS) and is implemented in production with several of the main vendors,” Clark told us.
“Because it does not compete directly with any LMS a customer may implement it with multiple different LMS solutions gaining delivery and procurement flexibility.”
He added most large pharmaceutical companies and CMOs have more than one packaging Line Management System (LMS) vendor, either due to historic, or strategic and risk mitigation reasons, and this latest offering could provide an option to aid integration between these systems while complying with serialisation regulations.