On August 18th and 23rd, LSPediA teamed up with Jennason to share crucial information on how trading partners should be preparing for the Drug Supply Chain Security Act’s (DSCSA) November 2023 implementation deadline, focusing on the challenges presented by serialization and interoperability.
No time to lose
Michael Ventura, LSPediA’s Vice President of Solutions and Innovations, emphasized that time is of the essence, and that much of the work for manufacturers and suppliers must be executed this year. Ventura clarified the FDA deadline as well as the industry deadline for DSCSA, and warned that without adequate preparation, any number of possible EPCIS data issues will halt product movement and send it to quarantine.
The challenge of serialization
LSPediA CEO Riya Cao detailed the increase in complexity between serialization at the package level and throughout the supply chain, as numerous issues can surface if data is inconsistent between partners. She noted that every part of the industry will be impacted by serialization, boosting the need for accurate data to support product movement at every trading partner level. Additionally, it’s not possible for any company to work their own data to perfection without interaction with their trading partners. Many factors are out of one’s individual control: trading partners may not have up-to-date master data; a pharmacy may not have a GLN number; syntax and semantic errors can easily occur; files can be sent late. Cao highlighted the direct connection of data to physical business outcomes: where data is stuck, a shipment is stuck.
A webinar poll asked the audience if they feel DSCSA is “Easy”, “Hard,” “Super Complex,” or “Over my Head.” Just 18% felt that DSCSA was “Easy.” The rest expected a significant challenge in compliance, with 45% finding it “Super Complex.”
While serialization might never be “Easy,” Cao said LSPediA is leading the industry by making DSCSA implementation easier by launching programs such as Compliance Guarantee, inclusive of training, technology, and qualified resources to execute serialization. The same Compliance Guarantee offers expert advice to review customers’ compliance position and create a customized plan to resolve gaps. Further, LSPediA seeks to ensure that customers benefit from serialization rather than simply meeting compliance targets.
Finding a place to start
Scott Pugh, Principal at Jennason, picked up the presentation to review key facts about how the 2023 DSCSA deadline will affect manufacturers, including the potential misstep of assuming that compliance solely requires establishing connections with downstream customers; rather, manufacturers must ensure that serialization is managed as a dependent process throughout packaging and distribution. They also need to be ready for an increase in exceptions that must be managed for operations to continue smoothly.
Pugh presented how trading partners can evaluate their existing capabilities and systems, and advised that they ensure that their planning for 2023 covers extensive testing, business process development, and efforts to identify automated tools and procedures for exceptions management.
Before signing off, Pugh presented a second poll, where attendees could give their view of their own serialization process. The options were “100% DSCSA compliant, “Mostly compliant, with some gaps,” “Has major gaps,” “How do I know?” and “I need help.”
Only 22% felt secure that their serialization efforts were DSCSA compliant, while the rest either felt they were somewhat compliant, were feeling pressure from compliance gaps, or were simply unsure.
The data suggests that 78% of companies have more to do with DSCSA implementation. LSPediA can help you take the next steps. Join us for future webinars, available on our Upcoming Events page, or contact us today.