A customer contacted Cleo to get help complying with serialization mandates in their supply chain.
Package serialization has been a hot topic in the wake of the US Drug Quality and Security Act of 2013. This federal law is meant to ensure consistency throughout the drug supply chain for prescription “track and trace” accountability.
In simple terms, serialization is the tracking of items at the product, pallet, and shipment level using unique serial numbers. This comprehensive tracking system is used mainly to reduce container tampering and product counterfeiting, a major problem in the pharmaceutical world.
California and Florida already had e-pedigree regulations in place, but those laws will be pre-empted by the new federal one. The rest of the U.S. and most European Union countries will follow suit by 2017.
The U.S. law began requiring a transaction document (TD) on Jan. 1, 2015, and serialization of all prescription products and their sealed containers by manufacturers will be required by Nov. 27, 2017. The TD contains transactional information and history, and several statements to certify compliance. After 2017, the TD must be in electronic form, and by 2023, further item-level mandates will be required.
So how does Cleo help? IT systems (including enterprise resource planning, product lifecycle management, and others) need to support serialization. All documents that will be electronically shared and every transmission must be secured. What good would it do if counterfeiters could intercept these documents and manipulate numbers and information for their own gain?
Also, a common method for sharing serialization information with trading partners is via electronic data interchange (EDI), which Cleo secures and reliably moves with its leading software solutions.
Of course, the tertiary benefit of serialization is the opportunity to use regulation as a business driver. Complex supply chains have led to a dispersion of supply chain control, which increases the chance of counterfeit goods infiltrating markets around the world.
However, having more visibility into a supply chain can help companies:
- Know exactly where their products are.
- Save money by reducing chargebacks.
- Limit liability when a product faces recall.
- Identify weaknesses in the supply chain.
Legislation that mandates drug serialization does not prescribe specific methods or technologies to be used, so it is left up to the manufacturers to select the appropriate means to securely transmit, track, and trace their drugs and their electronic documents.
How can better security, tracking, and supply-chain assurance help you? Find out with Cleo.