What Serialization Means for Pharma Manufacturing

Serialization is the assignment of a unique serial number to each salable prescription product unit. Each prescription product contains information about the product's origin, batch number and validity date.

In the pharmaceutical industry, counterfeit and substandard drugs threaten public health all over the world. These drugs are not only ineffective, but also dangerous drugs that have side effects and can even cause death. These counterfeit drugs can be produced in more than one place. This makes it difficult to trace and remove substandard and counterfeit drugs from the supply chain.

Many countries have made legal arrangements to prevent this rapid spread. In the United States of these countries, the Drug Quality and Security Act (DQSA) was signed in 2013. DQSA has outlined the identification and tracking of prescription drugs from the manufacturing stage to the distribution stage. These regulations apply to manufacturers, repackers, wholesale distributors, and third-party logistics providers.

What Does Serialization Mean?

Serialization is the assignment of a unique serial number to each salable prescription product unit. Each prescription product contains information about the product's origin, batch number and validity date. In the United States, serialization of all prescription drugs at both the salable unit level and the case level became mandatory in 2017.

How Does Serialization Work?

In the United States, the Food and Drug Administration (FDA) recommends the use of standard numerical identifiers. However, in these transactions, the serialized national drug code combined with a unique serial number is used. Serialization codes can be randomly or sequentially generated by the customer or the manufacturer. After the serialization codes are received, the manufacturer prints 2D barcodes on the shipping box and on the label on each salable unit.

The packaging line scans each label to determine which unit goes in which box. Because not every label is visible. For example, the bottles are lowered inside the boxes and each bottle has a temporary code on the top printed with UV ink. Major distributors claim that the FDA will soon require the collection of serialization data and verification of what serial numbers are on each bundle, box, and pallet. In order to access this information without opening every box, manufacturers need to aggregate data throughout the process. This information can then be sent electronically to the necessary stakeholders.

On the other hand, by 2023, all manufacturers are required to implement an electronic system that can track all packages of prescription drugs throughout the entire distribution chain.

Key Challenges in Serialization

Although serialization provides significant benefits in many ways, there are some difficulties in implementing this system. We can list the most important obstacles to serialization as follows:

Label Redesign

For many manufacturers, serialization means significant redesign of labels to make room for the new 2D barcode. As a result, changes in labeling cause redesign of packaging structure or graphic elements.

Maintaining Production Efficiency

New labeling requirements affect multiple packaging processes. Attaching labels, scanning bundles, boxes and pallets slows down the packaging line. Therefore, the manufacturer needs to increase its workforce or automation to maintain current production levels.

Data Management and Availability

In addition to changes in physical packaging processes, data management needs to evolve very quickly. The IT architecture must be able to create, store, detect and transmit millions of serial numbers for countless supply chains.

Creating Cross-Functional Team

The serialization process has both a knowledge base and a production base. Processing and packaging, engineering, labeling, quality assurance and project management all need to collaborate to keep the process running smoothly.

High Cost

Serialization requires a significant investment to meet the installation costs. To these costs, we can add the costs of updating existing materials, software, hardware, and training. Therefore, serialization is a costly process to set up and maintain.

How Serialization Improves Security

End-to-end serialization counterfeiting increases transparency and visibility by preventing parallel trade and theft. Moreover, with the ability to track the location of drugs, supply chain partners can improve shipping accuracy and eliminate recalled or defective drugs. In this way, patients can get their medications much more safely.

In addition, you can get detailed information about essential patient engagement strategies by reading our article titled Essential Patient Engagement Strategies See you on different topics.