The path towards compliance has many twists and turns. Presentations, discussions, and live demonstrations helped forum attendees navigate this path with new pharmaceutical regulations. Mentioned before, companies in the U.S. pharmaceutical supply chain face challenges ahead. They must capture and exchange data about each pharmaceutical unit, driven by the Drug Supply Chain Security Act of 2013. This regulation spells out multiple deadlines, with increasing demands each year until reaching full compliance in November 2023.
The DSCSA, and similar global regulations, demand error-free identification, and tracking. This covers billions of product transactions throughout the entire pharmaceutical supply chain. Data must also 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 such as this can allow them to learn from peers and industry experts.
Track-and-Trace Takes Center Stage
In partnership with pharmaceutical industry experts, Bell and Howell hosted a one-day traceability and pharma serialization forum in order to explore the new requirements and responsibilities on Nov. 17. Attendees benefitted from presentations delivered by serialization specialists and had time to discuss experiences with peers who have had similar challenges.
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 pharma 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. It also focuses on tested methods for storing and routing product information between manufacturer, distributor, and dispenser. Distributors take in many bundled and palletized products. Therefore, approaches to product aggregation served as 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 particular scenario may meet 2023 requirements as well. However, it will require the use of aggregation and inference in order to allow it to work.”
MacKenzie and Meyer 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.
Pharma Serialization Programs
A panel discussion also took place about lessons learned during pharma serialization programs. Various points of view were represented by our panel participants. Such members 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 pharma serialization journey.
Near the manufacturing floor, Mark Paul, Bell and Howell’s director of product development, led an equipment demonstration. It emphasized the abilities of the Pharma Factory solution to manage pharma serialization data. On this live packaging line, Bell and Howell software and vision technologies worked with Omega Design equipment, illustrating the serialization process. Then, Paul illustrated the flow of data from job initiation through carton printing, serial number commissioning, and product aggregation.