Few CMOs ready for serialization, say experts

Many contract manufacturing organisations (CMOs) have delayed adding serialization capability and now face an uphill battle to meet the EU's safety feature deadline.

According to industry experts, very few CMOs have finished or even started implementing a serialization strategy as they were waiting for the delegated regulation to be officially published. With this taking place in January the deadline for compliance is early 2019.

Many contract manufacturers do not have enough practical knowledge about the safety features of the EU Falsified Medicines Directive (FMD) and those that have started the process quickly discover it is a time-consuming and expensive process.

"As CMOs are usually small companies, the consequences of a wrong investment could become critical for their business," said Jean-Pierre Allard, chief technology officer of Optel Vision.

"These concerns are often why many wait until the last minute to start the process – but what they don’t know is it takes months to implement such a complex process and they should start sooner rather than later."

Along with partners TraceLink and Be4ward, Optel Vision is holding a seminar on March 30 at London's Heathrow Airport that is specifically targeted at CMOs, who face a particular challenge as they often have multiple customers.

The one-day event will provide first-hand knowledge of successful serialization projects, a clear explanation of the European regulations and advice on developing a serialisation strategy, along with practical considerations on equipment and IT systems  and integration with pharma customers.

"As we talk with the industry, the most common concern we hear is the lengthy period of eight to 10 months that it can take to integrate just one pharmaceutical manufacturer with a CMO," said TraceLink's director of CMO business Graham Clark.

"Because only a few of these projects can take place simultaneously, achieving 100 per cent integration with a point-to-point infrastructure will take years and the costs will be astronomical," he added.

More information on the seminar can be found here.