There is now less than 12 months to go before 100 per cent of medicine packs sold in the US must be serialized, and companies are now being advised to take the simplest route to compliance.
That means focusing on getting serialization in place without trying to build in aggregation –linking the individually coded packs with the codes used on cartons, cases, and pallets used in shipping, according to coding experts.
Steve Peterson of the Peterson Group and Mario Simard of Optel Vision told delegates at the Pack Expo pharma conference that aggregation is a 12-month project in its own right, and adding complexity that into the mix now will likely out too much stress on the serialization implementation process.
Implementing serialization on a line takes around 34 weeks on average – so companies starting out now will only be looking at 3-4 months for re-validation and to train staff on the upgraded lines. Running the two projects in sequence may end up costing a little more in the long run, but will help ensure companies successfully meet the November 2017 serialization deadline and avoid supply disruption.
Aggregation is likely to be required when the Drug Supply Chain Security Act (DSCSA) comes fully into force in 2023, and many larger drugmakers have been building the capability from the get-go as they serialize their packaging lines as this can reduce the overall cost of implementation.
There are an estimated 15,000 pharma packaging lines in operation worldwide, and if all the international regulatory initiatives for medicine traceability are added together it is clear that around 80 per cent of all drugs sold worldwide will have to be serialized by 2019.
“You will definitely miss the deadline if you try to do aggregation at the same time as serialization,” said Simard, who also noted that late adopters will start to face problems with capacity at serialization vendors.
Right now, it's thought that around 25 per cent of packaging lines worldwide are serialized, said Simard, although he suggested that could well be an over-estimate and it is clear that significant effort needs to be undertaken to meet the compliance deadlines.