Half of CMOs unprepared for serialisation requirements, says Tracelink

By Dan Stanton contact

- Last updated on GMT

Image: iStock/cosinart
Image: iStock/cosinart

Related tags: Pharmacology, Pharmaceutical drug

As many as 400 contract manufacturing organisations (CMOs) will not be ready for upcoming US and EU track-and-trace regulations, says supply chain services firm TraceLink.

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.”

Service offerings

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.

Related news

Show more

Related products

Transforming Clinical Development

Transforming Clinical Development

PerkinElmer | 01-Jun-2021 | Technical / White Paper

The estimated cost of bringing a drug to market in the U.S. according to JAMA is $1 billion.1 The extreme cost of clinical trials urge biopharmaceutical,...

Why Blister Packaging: Things to Consider

Why Blister Packaging: Things to Consider

Catalent Pharma Solutions | 03-Dec-2020 | Insight Guide

The decision to use blister packaging for either clinical trials or commercial drug manufacturing comes with a host of factors to consider. Pharmaceutical...

Vaccine Innovation in the Era of COVID19

Vaccine Innovation in the Era of COVID19

Covance Patient Safety | 01-Oct-2020 | Sponsored Link

During this time of worldwide crisis, there is an increasing demand for the acceleration of a vaccination for COVID19. Regardless of the great recent advancements...

Related suppliers

Follow us


View more