Implementing a Serialization Project Post DSCSA

Drug Supply Chain Safety Act

To comply with the new DSCSA, manufacturers are to investing in the systems, equipment, and processes to ensure that their drugs are serialized at each level of packaging.

It will be a significant investment regardless of size.

One of the leading global pharmaceutical manufacturers quickly came to recognize the enormity of what compliance meant.

Major changes were needed to systems, processes, equipment, and packaging as well as the very culture that defined how inventory was managed.

We have been successful in our recent serialization products but we have learned a few things about what to do, and what not to do.

1. For starters, don’t oversimplify the serialization project
2. For slower moving products you may not be able to justify the cost of retooling your manufacturing process to place serialized labels on units
3. Don’t make the mistake of assuming you will need to replace all of your scanning devices
4. Capturing serial numbers in a piece-pick operation will impact productivity
5. Your system needs to manage whether or not the product is serialized at the Lot level, not at the SKU level
6. Serialization projects bring other challenges that don’t have quite the clear-cut solution
7. When choosing a new system, be sure to look for a product that will grow and change with you

Serialization and track-and-trace concerns began with the Prescription Drug Marketing Act of 1987. Since then regulations have changed, been rewritten and reevaluated and have become the Drug Supply Chain Safety Act (DSCSA).

With patient safety driving the charge for serialization, no manufacturers can argue that it's the prudent thing to do but what history has shown us is that changes are inevitable and change is good.

How you deal with the change in your own business environment is the true question.