Pharma 'fears some CMOs are not ready for serialization'

There are concerns among the pharma industry that contract manufacturing organisations (CMOs) will not be ready to comply with emerging track-and-trace requirements.

That was one of the take-home messages at a roundtable meeting held earlier this year in Bethlehem, Pennsylvania, to gauge the readiness of the drug industry in serializing their products to meet new regulatory demands in Europe and the US, as well as emerging markets such as China, Brazil and South Korea.

Most of the top-tier pharmaceutical manufacturers are well on the way to compliance with the serialization demands of the Falsified Medicines Directive (FMD) in the EU and the US Drug Supply Chain Security Act (DSCSA), and there are signs that smaller drugmakers are also starting to get implementations underway.

There was however much less confidence that CMOs which are involved in packaging products for pharm clients will be ready in time, according to the serialization gurus who attended the event.

While there are certainly some CMOs who are aware of the task ahead of them and starting to prepare, an unnerving proportion are either completely ignorant of the ramifications of evolving legislation or - while aware - are at a loss how to get started.

"It became apparent through the discussions that a major component of capability for compliance for these global manufacturers is at risk," according to Tim Marsh (pictured), senior director serialization and supply chain security at Adept Packaging.

He noted that CMOs find themselves in a "tight spot", as they are being asked to make significant investments in people, equipment, software and implementation without being able to quantify a return.

Moreover, many do not have in-house staff tasked with staying abreast of regulatory developments, relying on input from their pharma manufacturer clients, and even if they are aware of the upcoming requirements lack the manpower to get a programme off the ground quickly.

As it stands, brand owners who contract production and packaging to the CMOs want to see programmes and investments in place well ahead of the compliance dates, as they know the implementation time is significant (typically as much as four to five years according to one recent survey).

"There was concern felt by the manufacturers given the low level of activity observed from the CMO sector," noted Marsh.

One solution to the issue proposed at the roundtable was to publish a CMO serialization tutorial and guidance document, something that does not exist at present but would be a boon to outsourcing partners aiming to start implementation.

Going a step further, those attending the roundtable discussed the possibility of developing a best practice guide - based on requirements the supply chain stakeholders have previously agreed to such as the use of interoperable GS1 standards - that could be used across the industry.

Rather than have a proliferation of guides from each pharmaceutical manufacturer, a single document developed by industry could be very beneficial.

Such a document would "help rectify disparate requirements emanating from individual companies and encourage proactivity on the part of the CMOs," said Marsh.

Adept Packaging now intends to start the process of developing a CMO serialization guide and would like to hear from pharma manufacturers and CMOs willing to participate in that programme.

"We won’t move the needle on any of this unless we continue to discuss this and plan for the future," concluded Marsh.