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The Drug Supply Chain Security Act (DSCSA) of 2013 requires packagers of pharmaceuticals to uniquely identify products according to the following simplified timeline.

2015

Supply chain capabilities.

2017

Product is serialized at the saleable unit.

2019

Distributors must track the shipment of serialized product.

2023

Product must be fully aggregated from item to case to pallet.

Our engineers have experience specifying, commissioning, and qualifying serialization systems. We have validated the serialization process and converted 70 products from non-serialized to serialized versions. These are complicated projects that require a range of skills, as well as a good understanding of the manufacturing process and how it will be affected.

Serialization Systems: We have enabled serialization systems from the industry leaders:

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Antares Vision

Packaging Line Equipment: Serialization systems must be integrated to existing line equipment. This adds a layer of complexity that is often out of the serialization vendor’s scope.

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Printers

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Printers

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Cameras

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Printer & Apply Units

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Case Packers

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Labelers

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Labelers

IT Interfaces: In addition to the line level systems there is a significant amount of IT interface development to link the serialization databases to Enterprise and External Data Repositories. Our engineers have done a significant amount of work in troubleshooting these interfaces and resolving the numerous errors that can occur when combining different systems and levels of systems.

Put our experience to work for you.

Online Resources:

Drug Supply Chain Security Act (DSCSA)

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Drug Supply Chain Security Act (DSCSA) Implementation Plan

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Drug Quality and Security Act

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Info@cGMPConsulting.com | Give us a call at 312-420-7682