Educational presentations, roundtable discussions and live equipment demonstrations helped attendees plan their next steps on the path toward compliance with new pharmaceutical regulations.
As mentioned in my previous blog post, companies in the U.S. pharmaceutical supply chain are challenged to capture and exchange data regarding the pedigree of each saleable pharmaceutical unit by the Drug Supply Chain Security Act of 2013. This regulation spells out multiple deadlines, with increasing levels of participation each year until full compliance is reached in November 2023.
The DSCSA, and similar global regulations, demand error-free identification and tracking of billions of product transactions throughout the entire pharmaceutical supply chain. This data also must remain traceable through secure and auditable data. For companies who need to know more about regulations affecting them and how to meet that challenge, a focused event can allow them to learn from peers and industry experts.
In partnership with pharmaceutical industry experts, Bell and Howell hosted a one-day traceability and serialization forum to explore the new requirements and responsibilities on Nov. 17. Attendees benefitted from presentations delivered by serialization specialists and had time to discuss experience with peers who have had similar challenges. Watch the video.
The forum included a regulatory update delivered by Randy Feldman, Excellis Health Solutions’ Chief Solution Architect. Feldman provided an overview of the most up-to-date information pertaining to legislation, the status of serialization and track and track implementation, and how it affected different categories of companies.
We were also fortunate to hear from two study participants about the outcomes of the Healthcare Distributor Alliance’s Pilot Study for Saleable Returns. The results from the HDA Supply Chain Trial were publicly released only a week prior, so this was a well-timed topic. Kevan MacKenzie of McKesson and Andy Meyer of NC Mutual Wholesale Drug Company worked together to outline the operational impact of the DSCSA’s 2019 requirements for distributors to verify serialized saleable returns from customers.
The 2019 DSCSA deadline focuses on the distributor, and the trial tested different methods for saleable product information to be stored and routed between the manufacturer, distributor and dispenser. Distributors take in significant quantities of bundled and palletized product, therefore approaches to product aggregation was an issue of key importance. MacKenzie and Meyer gave a detailed description of the real-life scenarios and solutions that their companies tested.
“The HDA and their participating members were able to pilot four options for manufacturers and distributors to be able to meet the 2019 verification requirements put forth by the DSCSA,” Meyer said. “All of these methods have positives and negatives unique to each scenario. One scenario in particular has the potential to be leveraged to meet 2023 requirements as well but will require the use of aggregation and inference in order to allow it to work.”
MacKenzie and Meryer went on to explain the transmission times for each data-routing scenario and the challenges each method presented. They concluded with aggregation best practices, and opened the floor for questions.
There was also a panel discussion on the topic of lessons learned during serialization programs. Various points of view were represented by our panel participants who included Russell Hill from 3C! Packaging, Todd Walter from United Therapeutics, Mike Kipfer from GSK and John Howells, a serialization consultant. The panel offered candid and helpful descriptions of their implementation, integration timelines and unexpected hurdles on their serialization journey.
Near the manufacturing floor, Mark Paul, Bell and Howell’s director of product development, led an equipment demonstration, which emphasized the abilities of the Pharma Factory solution to manage serialization data. On this live pharmaceutical packaging line, Bell and Howell software and vision technologies worked seamlessly with equipment from Omega Design to illustrate the serialization process. Paul illustrated the flow of data from job initiation through carton printing, serial number commissioning and product aggregation. Pharma Factory uses proven iQ and JETVision technologies to ensure reliable and transferable product history data.