Serialisation consortium reborn as coding mandates approach

Resurgence in interest in track-and-trace and electronic pedigree among drugmakers has prompted four companies to pool their resources and offer an end-to-end serialisation system that can "ensure patient safety, prevent counterfeit drugs entering the supply chain, and minimise diversion."

The 4 Serialisation consortium brings together specialists from data-handling specialist Acsis, printed packaging producer Nosco, vision systems specialist Cognex and Omega Design, which provides machinery and packaging expertise in what the partners claim is a comprehensive and flexible serialisation offering.

Gregg Metcalf, industry market manager for strategic initiatives at Nosco, told SecuringPharma.com that the new 4 Serialisation consortium is very new - with the foundations laid just a few weeks ago - but came on the back of what appears to be increasing appetite in the drug industry for serialisation.

"Momentum for serialisation waned after California's Board of Pharmacy put back the implementation deadline for ePedigree from 2011 to 2015, but with the new deadline on the horizon, coupled with the potential for an earlier pronouncement from the Food and Drug Administration, companies are moving ahead with due-diligence programmes," said Metcalf (pictured, with Acsis' chief technology officer John DiPalo).

Nosco and Acsis were actually part of an earlier consortium called California Express, which was set up in 2008 to help companies meet California's requirements. That group also included SupplyScape (now TraceLink, Hewlett-Packard, Systech and inCode) but dissolved after the deadline was set back.

In the interim of course, initiaitves from governments in countries such as Brazil, China and Turkey, as well as the prospect of federal guidance on pedigree and Europe's deliberations surrounding the proposed directive on falsified medicines, have put serialisation firmly back on the agenda for many companies.

"The new consortium has a platform that can deliver 'soup to nuts', in other words whatever a customer may need, including an entire end-to-end solution," according to Metcalf.

And while a client may not need such a comprehensive solution, access to the consortium means they deal with just one specialist team which can advise how to reach compliance with approaching ePedigree and serialisation mandates around the world, and cherry pick technology to their requirements, he added.

4 Serialisation can also offer some recently-developed products that the partners had the opportunity to showcase at the Pack Expo convention in Chicago last week, including Acsis' new Serialised Packaging Data Management (SPDM) solution and new machinery in Omega Design's OmegaTrack range.

"We had a complete demo running at Pack Expo illustrating how all the components can link together," said Metcalf, adding that Omega Design is also planning to set up the demo at its own facilities so customers can see the systems in operation.

Although most of the larger biopharmaceutical companies have started to adapt their internal production systems to accommodate serialisation, there is still a large number of tier two and three drugmakers, as well as contract manufacturing organisations, which have yet to start the process, mainly because of resource constraints.

And while generic pharmaceutical companies with narrower margins have hitherto been wary of investing in serialisation without a clear mandate from the federal government, attitudes seem to be changing.

"I'm aware of several generic drug manufacturers who are already conducting serialisation pilots," said Metcalf.  "The generic industry is looking at this just as seriously as the brandname drug industry."

From a data carrier perspective, it seems there is a mobilisation in the USA behind 2D datamatrix coding - in the same way as has occurred in Europe - as probably the least expensive way to get started with serialisation and this is helping to encourage generic drugmakers to get involved.

Meanwhile, some companies are continuing to make use of radiofrequency identification (RFID) tagging, although this is not generally for serialisation but for other processes such as inventory control and management. Down the line, however, Metcalf sees great potential for a hybrid approach of RFID tags on the case and pallet level with 2D datamatrix on the unit package level, an approach which was demonstrated well in the EU BRIDGE project.

"That approach makes the process a lot easier for the wholesaler, for example, as they don't need to hand scan every pack," he noted. "We're talking with a couple of Nosco customers right now about implementing exactly that kind of scenario."

Regulatory uncertainty

From a regulatory perspective there are clearly still many unknowns for companies. In Europe for example, the emphasis seems to be on a bookend approach to serialisation initially - with numbers applied at production and read at the point of dispensing and no attempt to track or trace the product in between. One advantage of this approach of course is that it can serve as a staging post on a path towards a full track-and-trace system in the future.

"I think that's an interesting idea that will probably come up as the USA moves its own serialisation discussions forward," said Metcalf, although with some states looking at pedigree without serialisation, the situation is extremely complex and many people are looking to the US Food and Drug Administration for guidance on a harmonised approach.

"FDA director Margaret Hamburg has come out in favour of pedigree and serialisation as a tool to secure the US supply chain, but I think we're at least a year to 18 months away from the federal government deciding whether to get involved on this issue."  

All that aside, "somewhere in the future, we will see some type of serialisation and potentially pedigree system mandated in the USA," he concluded.

 
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