In February, the service provider announced a significant capital investment that effectively tripled its capacity and will enable the company to realize serialization installation for more than 80 packaging lines across its global supply network, Justin Schroeder senior executive director, Global Marketing and Design at PCI Pharma Services told Outsourcing-Pharma.com.
Most recently, PCI upped its serialization capabilities at its Hay-on-Wye, UK-based facility, an expansion which Schroeder said is focused on maximizing flexibility to support global requirements, as well as specialization for the specific needs of the EU market and Falsified Medicines Directive (FMD) requirements.
“The [Hay-on-Wye] installation is one segment of a significant capacity expansion for our global serialization capacity in support of the execution of our clients’ serialization initiatives,” explained Schroeder.
The custom-engineered solution, developed in collaboration with Antares Vision and Marchesini, includes serialization technologies as well as tamper evident solutions and vignette labeling.
“To that end, we have significantly invested to be ready for the US and EU requirements, including preparedness for the overall scale,” said Schroeder.
“Where we see that others may have piloted or prepared in the investment of a line, we have been actively serializing commercial drug product for over five years across a multitude of lines.”
The extended serialization deadline
The US Food and Drug Administration (FDA) recently published a draft guidance in which it explained enforcement of the Drug Supply Chain Security Act (DSCSA) will be extended until November 2018 – adding an additional year to the original deadline.
Schroeder said that while the announcement provides the industry some “breathing room,” which is “certainly welcome,” the overall resources and continued investment for the industry remains considerable.
“Many in the pharmaceutical industry will absolutely need this additional 12 months to be in a position to succeed by November 2018,” he added noting PCI continues to see a significant lack of preparedness across the industry.
“The pharmaceutical companies and CMO’s have simply been slow to react and we are seeing the hockey stick effect on resource demand across the supplier market,” he added. “The various organizations that have petitioned the FDA for this delay have brought attention that there are limited resources to call upon for this scale of an initiative, which is now at a fevered pitch.”
Equipment providers, integrators, EPCIS solution providers, IT and Operational consultants, as well as contract manufacturing organizations (CMOs) are stretched considerably thin, said Schroeder, “and many are running substantially behind.”
However, he said PCI was fortunate to have anticipated much of the situation and have therefore been executing a strategy to insulate themselves. “Despite our being ahead of the curve,” Schroeder added, “it continues to be an ongoing challenge for the industry as a whole.”