Achieving Compliance with Pharmaceutical Serialization Requirements

Achieving Compliance with Pharmaceutical Serialization Requirements

With the introduction of the new Drug Supply Chain Security Act (DSCSA), the US has now joined many other countries that are are now mandating product serialization. This act is crucial in the attempt to establish a new system for the traceability of prescription drugs that will be phased in through a series of evolving requirements that will aid the law enforcement in the battle against prescription drug abuse. This act mandates pharmaceutical serialization for drug manufacturers and repackagers with the aim of enhancing pharmaceutical supply chain security and integrity.

This revision of the DSCSA which will be enforced in q3 of 2023 is an upgrade of the initial The Drug Supply Chain Security Act that was enacted in 2013 to strengthen the security of the pharmaceutical supply chain and prevent the distribution of counterfeit or adulterated drugs. The new revision also includes provisions for the investigation and enforcement of supply chain violations. The DSCSA is intended to improve the safety and security of the pharmaceutical supply chain and protect patients from receiving counterfeit or adulterated drugs, ads an extra layer of safety when it comes to prescription drug abuse and introduces additional safety measures to the complete pharmaceutical supply chain.

Serialization Compliance Considerations

The new revision of the DSCSA introduces new methodology for traceability of pharma products. The serialization needs to be carried out by a unique product identifier or serial number that are attached to packages or cases of drug products. The DSCSA requires that products come equipped with a Data Matrix, or 2D barcode, containing the product identifier and other unique data that serializes pharmaceutical products. The regulations of the DSCSA mandate that all participants in the US drug supply chain, including contract manufacturers and third-party logistics providers, to exchange compliance documentation with their trading partners and store the serialization data in a readily available location for a period of at least six years from the transaction date. All parties involved in the pharma supply chain need to introduce systems and processes to verify the accuracy of the documentation they receive along with the product identifier of suspect products.

There are many variables that need to be considered in your action plan for becoming compliant with the new Pharmaceutical Serialization Requirements. To name a few: the solution you opt in must be compatible with the ones that your associates that are integrated in your supply chain are using. You need to be aware of the type of serialization data is shared with you and whether your systems can parse it.

You need to be aware whether your current labelling hardware supports serialization and storing and sharing of serialized data. You need to be sure that your serialization hardware can work with the serialization software.

Facilities shouldn’t consider this new DSCSA requirements as an additional expense as there are many solutions that can be retrofitted on your current equipment. Just be sure that they are compatible. There are a ton of other important things to consider, but this can easily become a book and not a blog article.

Pharmaceutical Serialization Solutions

We are pleased to announce that we have partnered up with HICOF, a Swiss Serialization Systems Software and Hardware manufacturing company. HICOF is the innovative and dynamic technology leader in the Track & Trace industry.

All of the considerations that we’ve outlined in the previous chapter can be solved with HICOF. They solve all compatibility issues as their serialization solutions can be retrofitted to upgrade existing lines. HICOF have successfully upgraded machines from other manufacturers to assure they don’t go out of commission because of the new serialization act. What they typically do in such cases is to retrofit a serialization solution called “HECTOR” with camera and printer that upgrades the existing hardware.

HICOF is one of the very few companies on the market that understands the importance of scaleable serialization solutions based on your current needs. Their hardware and software can easily work with variable production speeds as well as packaging type and size. By design, HICOF’s serialization software is super flexible so their L4 serialization solution can be connected to any existing production line interfaces. In case you don’t have such, or you’d like to switch to their integrated solution, the software comes with interface generator a really useful feature that allows you to generate your user interface by yourselves based on your specific needs.

When it comes to integration with other parties within the supply chain, HICOF’s serialization software runs natively on the cloud that allows fast setup, data retrieval and rollout. Having the data stored on the cloud means that all parties in the supply chain can easily refer to the product info data in the cloud and verify the retrieved information.

One of the many unique things that makes HICOF a true leader in serialization solution providers is that they are both a Software and Hardware suppliers. They offer turn-key solutions combining their own serial data management software with industrial production lines for coding of packs and aggregation of serialized packaging hierarchies. For the customer this means: One solution – One supplier – One responsibility.

We’ve done a great presentation on the biggest challenges of the 2023 US serialization mandate and how we can guide you through those. Feel free to watch the embedded video below:

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