A Step-by-Step Guide to Implementing An Effective Track-And-Trace Program

Although a universal standard for pharmaceutical track-and-trace solutions has yet to emerge, the California Board of Pharmacy’s ePedigree requirements are currently driving action in efforts toward implementing serialization to provide supply-chain integrity to the public. While several states are actively pursuing similar legislation, California’s pending requirements are the most demanding in that they track product to the smallest saleable unit level.

Enforcement of California’s ePedigree legislation has been delayed several times; however, the current initial enforcement date of January 1, 2015, is expected to stand, and similar efforts on the federal level may not be far behind. This, combined with the accelerated pace of regulatory involvement worldwide in serialization and track and trace, means that it is now vital that the industry accelerate its efforts to put compliance measures in place.

At Aphena Pharma Solutions, we have developed a step-by-step process that has helped us establish a very effective track-and-trace program, and we are sharing the steps we followed in hopes that they might be beneficial to others in the industry seeking to implement compliant track-and-trace systems.