A Guide to Serialization For Pharmaceutical Manufacturers

Over the years, governments and regulatory bodies have been forced to crack down on the rise of counterfeit pharmaceutical products entering the market to prevent harmful medicines from being distributed to consumers.

As a result, manufacturers in the pharmaceutical and medical device industries invest significant time and resources to ensure their production processes align with stringent regulatory requirements and enable them to trace the ingredients and actions involved across their supply chain and production facilities, all the way to distribution.

To reduce the significant risk of harm that can result from faulty medicines entering the market, governments and regulatory agencies have implemented strict laws enabling them to impose harsh penalties on individuals and businesses found to be producing and distributing counterfeit and/or unapproved medicines.

For instance, in 2019 alone, investigations conducted by the US Food and Drug Administration’s Office of Regulatory Affairs netted 257 arrests, 239 convictions, and $2.3 Billion in forfeits, fines, and restitution resulting from the manufacture and distribution of counterfeit pharmaceutical products.

In order to avoid the potential consequences associated with the enforcement of these regulatory policies, manufacturers have adopted a serialization process that enables governments and oversight agencies to track medical products once they’ve been distributed into the market.

In this post, we’ll provide an overview of pharma serialization, why it’s important for manufacturers, and how businesses are simplifying their serialization processes to increase efficiency and streamline compliance efforts.

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Product serialization in the pharmaceutical industry is the practice of generating a unique identifier for pharmaceutical products and printing the code on the label or packaging prior to distribution.

While serialization may look slightly different from country to country, the labels generally all include a unique serial number, identification code, batch number, and expiration date.

Serialization is a critical tool used by regulatory agencies to prove the validity of pharmaceutical products, enabling them to track the item(s) back to the original manufacturer. The serialization process can also provide a lot of value to the manufacturer as well.

Some of the benefits of serialization include:

Clear and comprehensive supply chain visibility: The pharmaceutical industry possesses one of the most complex supply and logistics processes. Because of this, manufacturers need unique product identifiers to keep an eye on where the materials and ingredients are located along their supply chain.

Serialization helps pharmaceutical manufacturers monitor and supervise their complex logistics operations more effectively and efficiently. With proper serialization, manufacturers have a clearer picture of their processes in all areas of their operation.

Authentication of brand products to combat counterfeiting: Unfortunately, it’s not uncommon for criminals and counterfeiters to take advantage of the high demand for drugs and medical devices to provide alternatives to desperate and unwitting consumers. These alternatives are usually counterfeit, bearing a genuine pharma brand.

However, such products don’t pass the necessary quality and compliance standards, putting end-users at risk of serious harm and even death. Therefore, pharma serialization is essential because it allows parties to discern between genuine products and counterfeits.

Scannable codes can quickly show whether or not specific items are part of a batch from the stated pharmaceutical company.

Coordinated and effective product recalls: Sometimes, drugs and medical devices can harbor unforeseen issues, requiring them to be withdrawn from circulation in the market. Serialization allows manufacturers to track and trace problematic batches in conjunction with government agencies.

Well executed pharma serialization makes these recall efforts more efficient because companies can rely on their systems to track the products from their origin in the factory to pharmacy shelves around the globe.

Assessing product consumption rates to inform manufacturing decisions: Pharmaceutical manufacturers can utilize serialization to label and track products from when they leave the factory to the market. With this practice, manufacturers can track different batches to determine and examine their uptake by the consumers.

Such information allows pharma manufacturers to better understand the demand for their products, allowing them to procure raw materials as needed for the next production run to fulfill orders.

Modern pharmaceutical businesses run sprawling manufacturing operations, requiring more advanced serialization methods. For instance, basic serialization processes involve appending unique identifiers to all primary, secondary, and tertiary packaging.

These identifiers are broad, ranging from the country of origin and narrowing down to the granular product level. As mentioned, serialization labels typically include information such as:

1. Global Location Number (GLN) to show country of origin

2. Global Trade Item Number (GTIN) to identify the type of product

3. Serial Number as a unique identifier for each product under the particular GTIN

4. Lot information to identify manufacturer-specific batches of products from the same production run

5. Expiration date

Different regulatory jurisdictions require various serialization technologies to make the above information readable by humans and machines. Many manufacturers rely on thermal InkJet to print 2D barcodes or QR codes with identifying information onto product packaging.

The advent of Pharma 4.0 technologies makes the serialization easy to digitize and seamlessly build into the production process.

For instance, using Tulip, pharmaceutical manufacturers are easily able to incorporate the production data that is collected throughout the manufacturing process into their serialization efforts, reducing the amount of human input necessary.

Ultimately, this eliminates the possibility of human error and ensures that manufacturers are able to make compliance a seamless part of their production and packaging processes.

If you’re interested in learning how you can implement Tulip to optimize your quality and compliance initiatives, please feel free to reach out to a member of our team today!