CMOs still not stepping up to serialization challenge; poll

A survey suggests pharma contract manufacturing organisations are still not moving fast enough to meet serialization deadlines in the US.

Audience surveys conducted at a TraceLink webinar at the end of March revealed that that 91 per cent of CMOs and 87 per cent of their customers believe they will be ready for the November 2017, the deadline for assigning serial numbers to individual packs of prescribed products sold in the US.

However, other responses seemed at odds with that assessment. Only one in five CMOs reported that they have a full picture of their customers' requirements, while in a third of cases discussions have not progressed beyond preliminary discussions.

Similarly, just one in five CMOs said they understand their customers' requirements with regards to the timing implementation, and only one in seven had selected a serialization vendor.

"Both parties need to start having conversations right away to ensure compliance readiness," according to TraceLink, which notes that only 6 per cent of CMOs reported they have secured slots in their customers' onboarding schedule.

"By now, line equipment should have been ordered, though only 14 per cent reported having done so," it continued. "CMOs should also have the technical requirements from their manufacturers, although only 9 per cent said they have received them."

The webinar was attended by hundreds of delegates who heard how four pharma companies - Abbott, Merck KGaA, Sanofi, and Teva - are collaborating with CMOs on the implementation of serialization.

"As they addressed the complexities of technical requirements, onboarding schedules, and choosing a serialization vendor, the message from the four top brands was clear: get going now to avoid the risk of halting supply and driving up costs," concluded TraceLink.