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How does serialization support pharmaceutical integrity?

Gianni Linssen
Written by
Gianni Linssen
/ Published on
April 11, 2024
serialization in pharmaceutical industry

In pharmaceuticals, there's a silent process that plays a critical role in the journey of a medicine from its manufacture to the moment it's in the hands of a patient. It's known as serialization, and while it might not be the stuff of headlines, its function is crucial for ensuring the authenticity and safety of medications worldwide.

A label that speaks volumes: How serialization works

Picture this: a line of cartons, wallets or bottles move steadily along a conveyor belt. At first glance, they're identical. But a closer inspection reveals something unique—a series of characters printed on each label, differentiating one package from the next. This series of characters is an essential part of pharmaceutical serialization. It provides a distinctive identity for each product, a digital fingerprint that follows it from inception to expiration.

Beyond the barcode: Why serialization matters

It's not just a tracking mechanism; serialization is a pact with the patient. When a medication is serialized, it carries a guarantee. It's a product that has been counted, recorded, and validated through every stage of its existence. This system roots out counterfeits, ensuring that the medicine reaching a consumer is genuine, intended for their use, and safe.

Compliance is just the beginning: Serialization and global standards

In the world of medicine manufacturing, rules aren't just suggestions—they're must-follow directives etched in the fabric of the industry's operations. Serialization is enforced by weighty regulations like the DSCSA in the United States and the FMD in Europe. These are not mere guidelines but blueprints that shape the landscape of drug distribution, designed to protect patients and ensure the veracity of pharmaceutical products at every turn. Learn more about effective pharmaceutical packaging design guidelines.

Technology's tightrope: Balancing speed and precision in serialization

Managing serialization is done by combining machinery and technology. It requires printers capable of etching codes at high speeds and software sophisticated enough to track these codes across continents and through various hands. The complexity is challenging, but the payoff is worth it — a world where every medication can be traced back to its source with the click of a button.

In the patient's palm: The end goal of serialization

Consider the journey of a single pill, positioned within a blister pack, embossed with a code. That pill's journey from a factory to a pharmacy shelf is full of checkpoints, each scan a reassurance of its legitimacy. For the patient, this is more than convenience; it's confidence. Confidence in the knowledge that their treatment is legitimate and safe, backed by an unbroken chain of accountability.

Sustainability: The unexpected dividend of diligent tracking

Serialization's benefits echo beyond patient safety. It's also about stewardship—of resources, of the environment. By pinpointing exactly where products are and how they move, pharmaceutical companies can slash waste, cutting down on the production of excess medication and minimizing the carbon footprint of their distribution networks.

A future proofed by numbers: The trajectory of serialization

Looking ahead, serialization is set to become even more integrated, more precise, and more integral to the fabric of pharmaceuticals. In this future, serialization will not only guard against counterfeit drugs but also pave the way for more direct and personalized patient care.

Recommended reading: Understanding why rare diseases need innovative packaging solutions

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Wim Henk Stoppkotte

Wim Henk Stoppkotte

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Gianni Linssen

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