With the introduction of the Drug Supply Chain Security Act (DSCSA) in 2013, all pharmaceutical manufacturers, distributors, packagers and retailers will be required to provide full traceability of goods across the supply chain by 2023. The date may seem far off, but now is the time for these entities to be looking at the challenges holistically by proactively developing their operational future-state maps that enable compliance with the act.
While the regulation is far-reaching and is the first of its kind on a national scale, it’s premise is simple: Drug packaging must contain a unique identifying 2D barcode that can be referenced as it moves along the supply chain—enabling the FDA to trace a drug’s path should a problem arise. The regulation’s objectives are noble, as some estimates have counterfeits making up 15% of medicines in circulation. Consumer safety will rise tenfold through increased supply chain visibility, preventing these falsified drugs from reaching the end user.
With such reform comes a whirlwind of serialization discussions in Life Science publications, forums, and by solution providers, primarily focusing on the technical and IT changes that will facilitate data transfers along the secure supply chain. Rightly so, manufacturers are busy serializing their products and overhauling packaging lines. Distributors are piloting new software and physical infrastructure to scan products from receipt through order fulfillment.
While these changes are no doubt critical to the success of an effective serialization program, it is not the end-all be-all solution that will satisfy the FDA’s pedigree regulations—it only lays the groundwork.
To become a best-in-class Pharmaceutical business in the age of serialization, Life Science manufacturers, distributors and vendors cannot implement these technical changes without addressing the human and operational process hurdles. In short, the pharmaceutical industry needs to be redesigning their operational processes in tandem with IT pilots, creating a track-and-trace system that is truly end-to-end.
To avoid bottlenecks, map out the current state of all operational processes. Design the future-state map to include the new implications brought on by DSCSA and identify the gaps between the two. Pharma organizations should be asking themselves, “What changes can we preemptively design, standardized and develop training?”
The story is not an unfamiliar one. Too often companies implement new ERP systems, manufacturing modules, or equipment presuming it will be the answer to their operational challenges. No IT solution can succeed without well-designed and well-documented standard operating procedures, management routines and a culture that is bought into the changes.
The Drug Supply Chain Security Act is leading to radical reform of pharmaceutical traceability and requires a tremendous amount of work. With this effort come the opportunity for companies to get ahead of the serialization curve to be a best-in-class company. Companies that wait too long to develop the business processes that support the scanning and processing of drugs are only doing themselves a disservice and risk not meeting the deadlines set by the FDA over the next 7 years. Company-wide initiatives addressing the processes surrounding these changes should be developed now to avoid delay in meeting regulation.
By Leah Schultheis, Consultant Tefen USA