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

Although the 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 since they track product to the smallest saleable unit level.

Enforcement of the ePedigree legislation, combined with the accelerated pace of regulatory involvement worldwide in serialization and track-and-trace means that it is now vital for the industry to accelerate its efforts to put compliance measures in place.

Aphena Pharma Solutions has developed a step-by-step process to help establish an effective track-and-trace program:

• Compliance Matters
• Ask the Right Questions to Form Your Strategy
• Test, and Test Again
• Internal Corporate Requirements

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