Saturday, May 26, the pharmaceutical industry will be just six months out from the DSCSA serialization enforcement date of Nov. 26, 2018. The deadline for compliance remained Nov. 27 of 2017, but last summer, the FDA stated they would not enforce the manufacturers’ unit-level product identifier requirements under the DSCSA for another full year.
With deadlines looming, resources for equipment and software have been put to the test, with some manufacturers citing long lead times for system implementation. With this in mind, many providers have developed preconfigured systems to get existing lines compliant quickly, without quite as many bells and whistles or customization.
Persistence Market Research suggests that the biggest issue facing those who require pharmaceutical traceability is the cost. “Estimates range from a conservative $250,000 all the way up to $1 million per line depending on how complex and automated it already is. These lines will experience production downtime while the changes are being made causing potential sales revenue losses,” says Persistence in its upcoming report, Track-and-Trace and Serialization Market: Global Industry Trend Analysis 2012 to 2017 and Forecast 2017 – 2025.
