Serialization in Pharmaceuticals: A New Approach in 2025

Serialization in pharmaceuticals plays an increasingly crucial role in ensuring the safety, security, and traceability of pharmaceutical products. This system is designed to combat the growing concerns surrounding counterfeit and falsified medications, which pose a serious threat to public health worldwide. These counterfeit drugs are not only ineffective but can also be harmful, leading to adverse reactions or even death. They are often manufactured across different regions, with components such as active ingredients being produced in one country, fillers in another, and packaging occurring in a third. This complex and fragmented production process makes it incredibly difficult to trace and eliminate counterfeit drugs from the supply chain.

In response to these growing concerns, the United States government passed the Drug Quality and Security Act (DQSA) in November 2013. Title II of the DQSA outlines the steps necessary to build an electronic system capable of tracking and tracing pharmaceutical products throughout the supply chain, from manufacturing to distribution, and ultimately to patient consumption. The regulations apply to manufacturers, repackagers, wholesale distributors, dispensers, and third-party suppliers involved in the pharmaceutical supply chain.

Serialization in Pharmaceuticals: What it Does

Serialization in the pharmaceutical industry involves assigning a unique identifier to each product, which allows the tracking of a product’s origin and batch details, such as its batch number and expiration date. The serialized product is tracked from the manufacturer to the end consumer, ensuring transparency and traceability at every stage of the supply chain.

The process begins when the manufacturer generates a unique serial number for each product. This number is printed on labels or cartons using a barcode system. The manufacturer maintains a comprehensive record of these serial numbers for every batch of product that is produced. As the product moves through the supply chain—from manufacturing to retail distribution and, finally, to the patient—each unit is tracked and traced via its serial number.

In the U.S., the Drug Quality and Security Act mandates that every pharmaceutical product sold within the country must be serialized at the marketable unit level. This includes the individual packages of medication, which must be identifiable with a unique serial number that is tracked through each phase of the distribution process.

Serialization Process Flow

The serialization process involves several stages to ensure that every unit of a pharmaceutical product is traceable from its production to its final distribution. The Food and Drug Administration (FDA) has established guidelines that recommend using standard numerical identifiers (SNRIs) for serialization. The serialized National Drug Code (sNDC) combines the traditional NDC with a unique serial number, creating a distinct identifier for each product unit.

The typical serialization flow includes the following steps:

1. Initial Processing and Serialization Code Generation: During the manufacturing process, a serial number is generated randomly, and this code is associated with the product. The manufacturer then prints a 2D barcode on each label, which contains the serialized code.
2. Tracking and Scanning: Each label is scanned to track which specific unit goes into which final packaging. For example, the first carton is printed with a 2D barcode, and after scanning, it is associated with a particular shipper. Several shippers may be grouped together on a pallet.
3. Data Aggregation and Electronic Reporting: Distributors are required to collect and verify serialization data, ensuring that serial numbers are included in each package, shipper, and pallet. This data is aggregated and transmitted electronically through an Advance Shipping Notice (ASN). The data is retained by all parties in the supply chain to comply with FDA regulations and audits.
4. Traceability through the Entire Distribution Chain: By 2023, manufacturers will need to implement an electronic system that traces every pharmaceutical package through the entire distribution chain. This will provide end-to-end visibility, from production to the final dispensing to the patient.

Key Challenges in Serialization

While serialization provides numerous benefits, it also introduces several challenges at different stages of the pharmaceutical manufacturing process:

1. Redesign of Packaging: Manufacturers often face the challenge of redesigning packaging to accommodate serialization requirements. This may require significant changes to label formats, packaging structure, and the incorporation of new technologies, which can be costly and time-consuming.
2. Reduced Production Efficiency: The serialization process can slow down the manufacturing line due to the added steps of printing labels, scanning products at each stage, and verifying serial numbers. To mitigate these delays, manufacturers often need to allocate more manpower and resources to maintain production efficiency.
3. Data Storage and Management: The generation, storage, and retrieval of large amounts of serialization data can create challenges for IT departments. Companies must invest in secure, scalable storage systems that can handle vast amounts of product-related information.
4. Lack of Trained Personnel: The complexity of the serialization process requires a highly skilled workforce. Personnel from various departments, including IT, maintenance, packaging, and quality assurance (QA), must be adequately trained to ensure the smooth operation of the serialization system.
5. Cost Considerations: Implementing serialization can be costly, particularly for companies that need to upgrade or replace existing machinery, software, and hardware. The investment in new technologies can be a significant financial burden for manufacturers, especially smaller companies.

Benefits of Serialization

Despite the challenges, serialization offers numerous advantages for the pharmaceutical industry:

1. Improved Supply Chain Visibility: Serialization allows companies to gain real-time insights into the location and status of products at every stage of the supply chain. This visibility helps improve demand forecasting, inventory management, order fulfillment, and delivery accuracy.
2. Enhanced Product Recall Management: In the event of a product recall, serialization allows companies to quickly identify and retrieve affected products. This helps mitigate the risks associated with widespread contamination or faulty products.
3. Streamlined Supply Chain Operations: Serialization data can be used to automate various aspects of the pharmaceutical supply chain, including procurement, invoicing, warehouse management, and performance measurement. This automation reduces errors and improves operational efficiency.
4. Combat Counterfeit Drugs: The most significant benefit of serialization is its ability to prevent the proliferation of counterfeit drugs. By tracking the movement of each product from manufacturing to the point of sale, serialization makes it easier to identify and eliminate counterfeit medications from the supply chain, protecting patient safety.
5. Regulatory Compliance: Serialization helps pharmaceutical companies comply with increasingly stringent regulatory requirements. It ensures that all products meet the standards set by the FDA and other regulatory bodies, which is critical for market access and patient safety.

Information Contained in Serialization Labels

Serialization labels contain several key pieces of information that help identify and track each pharmaceutical product:

• Global Location Number (GLN): This identifies the country of origin of the product.
• Serial Number: A unique identifier assigned to each product, ensuring that it can be traced through the supply chain.
• Global Trade Item Number (GTIN): This identifies the type of product and is used in conjunction with the serial number to track the product’s journey.
• Lot Information: This provides details about the production batch, helping distinguish between different batches of the same product from the same manufacturer.
• Expiration Date: The expiration date is crucial for ensuring the safety and efficacy of pharmaceutical products. Serialization ensures that expired products are removed from the supply chain.

FAQs

What is product serialization?

Serialization is the process of assigning a unique identification number to each pharmaceutical package, typically in the form of a 2D barcode or DataMatrix. This identifier allows the product to be tracked through the supply chain, ensuring its authenticity and safety.

What is track and trace serialization?

Track and trace systems allow companies to monitor the movement and location of products in the supply chain. Track refers to understanding where the product is at any given time, while trace refers to understanding the history and journey of the product throughout its lifecycle.

How is RFID used in pharmaceuticals?

Radio Frequency Identification (RFID) is a technology used to track pharmaceutical products via RFID tags. These tags can be attached to products to provide additional security and traceability, making it more difficult for counterfeit drugs to enter the supply chain.

What type of information is contained in serialization labels?
Serialization labels include information such as the Global Location Number (GLN), a unique serial number, the Global Trade Item Number (GTIN), lot information, and expiration dates. This data helps ensure that each product is properly identified, tracked, and traced throughout the supply chain.

Conclusion

Serialization in pharmaceuticals is an essential tool for improving the safety, security, and efficiency of the global pharmaceutical supply chain. By assigning a unique identifier to each product and tracking its movement through every stage of the distribution process, serialization helps prevent counterfeit drugs from entering the market and ensures the safety of patients. Despite the challenges involved in implementing serialization, the benefits far outweigh the costs, making it a critical component of modern pharmaceutical manufacturing and distribution practices. As technology continues to evolve, serialization will become even more streamlined and efficient, further enhancing the integrity of the global pharmaceutical supply chain.