pharma serialization

What the U.S. DSCSA Deadlines Mean for Pharma

We live in an age where our medical community has extraordinary capabilities, but as operations scale and expectations increase, pharmaceutical manufacturing practices fall under more scrutiny than ever. While these new oversights and regulations introduce more transparency and accountability into the pharmaceutical supply chain, they also carry with them the tremendous costs of compliance.

In particular, mandates passed under the Drug Supply Chain Security Act (DSCSA) come into effect in November 2017, just a few months away. These mandates require drug manufacturers to begin providing serialized item-level traceability for every single product shipped, allowing any single defective product to be traced back to its individual production facility, lot number, and manufacture date. These changes are expected to be implemented in full by 2023, putting pressure on pharmaceutical companies and their processing units to adopt the technology needed to uphold compliance.

As a result of these major shifts, which include a revision to GS1 US guidelines, pharma manufacturers will need to make significant investments on printing, serialization, scanning, and packaging technology so that operations can continue to keep production rates high and overhead low.

How the DSCSA Changes Pharma Production

Signed into law by former president Barack Obama in 2013, the Drug Supply Chain Security Act (DSCSA) was created in response to manufacturing oversights that contributed to incidents like the fungal meningitis outbreak that occurred in 2012.

The law sets timetables for implementing phases that represent significant changes to supply chain management and internal manufacturing practices. For instance, new guidelines were published in 2014 governing minimum standards for transaction data and other supply chain management activities so that any tainted batches can be traced more clearly to specific shipments and production runs.

Guidelines coming into effect this year, with an intended 2023 full-implementation deadline, bring this focus down to the product level. In essence, every single bottle of pills in a shipment should be traceable back to an individual production run at a specific time and place in a facility. Abiding by these strict standards means that production facilities must have measures in place to individually label items with serial numbers that can be read and traced.

These measures can also help regulatory enforcement to rapidly identify counterfeit or tampered products.

Why the DSCSA Requires Automation, Coding, and Scanning

To outline the requirements of the DSCSA specifically: Each manufacturer must now mark individual retail packages or bulk shipments with a product identifier, unique serial number, lot/batch number, and expiration date.

Complying with these regulations — which include mandates on storing data for at least 12 years — means that manufacturers will need a system for creating serial numbers, tracking them, and storing them inside a massive, searchable database. On a physical level, each product must be marked by a unique serial number readable by both machines and human eyes.

In order to meet these demands, pharmaceutical manufacturers will have to invest in automated printing, coding, and scanning equipment within their production line along with variable print controller machinery that can interact with a product database.

If your current production facilities are not yet up to this task, you can reach out to a production equipment specialist who can help bring your manufacturing process up to compliance while helping you achieve the maximum ROI.


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