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.

Serialization has moved from a best practice to a legal requirement. Most countries now demand that every saleable unit of medicine be uniquely identified and traceable through the supply chain. Without it, products can’t move, and patients can’t be protected.

FDA’s DSCSA and 21 CFR Part 11
In the United States, the Drug Supply Chain Security Act (DSCSA) defines how prescription drugs must be traced from manufacturer to dispenser. By 2024, all trading partners like manufacturers, repackagers, distributors, and pharmacies are required to share serialized transaction data electronically. The goal is simple: make it possible to verify product authenticity and act fast when there’s a recall or suspected counterfeit.

But compliance goes beyond labeling. The systems that hold and exchange serialized data must meet FDA 21 CFR Part 11 standards. That means validated software, secure access controls, and complete audit trails so every record stands up to inspection.

EU Falsified Medicines Directive (FMD)
In Europe, the Falsified Medicines Directive (FMD) has set a firm standard since 2019. Every prescription drug sold in the EU must include a unique identifier and tamper-proof seal. Each pack is verified through the European Medicines Verification System before it reaches a patient.

Manufacturers have to maintain data exchange with both the EU Hub and national repositories. Accuracy is critical, one mismatch in data or timing can block product release or trigger investigation.

WHO and ICH Guidelines
Global manufacturers also follow broader guidance from the World Health Organization (WHO) and the International Council for Harmonisation (ICH). These groups focus on alignment by defining how product identifiers, barcodes, and digital records should be structured to work across borders.

WHO’s “Technical Implementation of Track and Trace Solutions” is especially relevant. It lays out how data formats, barcode symbols, and system design should support interoperability among different national systems.

The Direction Ahead
Regulations will keep tightening. What’s consistent across regions is the expectation for reliable data, full traceability, and transparent product movement. Companies that build flexible, well-validated systems now will find it easier to adapt when new serialization rules appear, without interrupting production or risking shipment delays.

Serialization starts on the packaging line, but the work doesn’t end once a label is printed. Each code must link back to data that can prove where a product came from and where it’s going. The physical mark and the digital record have to move together.

Coding, Aggregation, and Verification
Each saleable unit gets a 2D data matrix with the product ID, serial number, expiration date, and lot number. Printers handle this at high speed. The marks need to be clean and easy to scan, one bad print can stop a line or waste a batch.

After coding, units are packed into cases and pallets. Each group receives its own code so the system knows what sits inside what. That structure makes it possible to trace one carton or a full shipment without confusion.

Scanners and vision cameras check every printed code. They confirm it’s readable and linked to the right batch. If one fails, the line stops or the pack is kicked out for rework.

The machines can manage these steps, but without a connected system the data sits in separate files. That’s where most compliance problems start.

Electronic Batch Records and Data Capture
Serialization depends on reliable data more than anything else. Electronic batch records keep that data organized. Each event like who printed, who verified, which line was used is logged automatically. No paper, no manual signatures, no lost entries.

When a regulator asks for proof, the record is already there. You can see the serial numbers, scan results, and equipment details in one place. The same record also ties to yield data, deviations, and quality checks, which helps track the impact of any error before the product ships.

Scanners, sensors, and line controllers feed data directly into the batch record. That link closes the loop between the physical and digital sides of production.

Integration with MES and LIMS
Serialization runs smoother when it connects to the systems that already control the line and manage quality.

The MES triggers the printing and aggregation steps, then verifies that the right serial numbers are applied before release. The LIMS holds the test results that decide whether a batch can move forward. When both connect to the serialization system, only approved batches receive active serials.

If those systems don’t talk to each other, you end up chasing data across spreadsheets and servers. When they do, traceability holds together and production keeps its pace.

Serialization isn’t about extra equipment or new software on the line. It’s about making sure every printed mark has a verified, retrievable history. Once that link is solid, compliance becomes routine instead of a scramble.

Serialization sits inside the GMP framework. It’s not an add-on or a separate function. The same expectations apply: the data must hold up, the systems must be proven, and the records must survive an audit.

Data Integrity
Each serialized pack tells a story. Where it came from. When it was printed. Who checked it? Whether it met quality limits.
If that story breaks at any point, the traceability fails.

Under GMP, the basics don’t change:

• Data has to be accurate and complete.

• Access must be limited and traceable.

• Records must be created when the work happens, not after.

A scanner rejecting a code or an operator logging a rework, those actions need to be captured right then, not filled in later. Paper and hybrid setups often leave blanks. Those blanks turn into audit findings.

Electronic systems close those gaps. They timestamp every entry, tie it to a user, and keep the data intact. That’s what inspectors want to see: a record that can be followed without guessing.

Validation
Serialization equipment and software affect how a product is identified, released, and, if needed, recalled. Because of that, they fall under validation control.

The common sequence still applies:
IQ checks the installation.
OQ tests that the system runs within limits.
PQ confirms it performs properly in production.

For serialization, that means proving the printers apply readable codes, the aggregation logic holds, and the data flows correctly between systems like MES, EBR, and ERP.
If any of that changes i.e. a software patch, a line reconfiguration, a new interface the validation needs to be revisited. Skipping that step usually shows up later during an inspection.

Why It Matters

A validated serialization setup isn’t just for compliance. It prevents small data errors from spreading into larger ones. It keeps the audit trail intact. It gives production and QA the same version of the truth.
When that happens, recalls move faster and investigations stop turning into hunts through paperwork.

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.

Serialization works best when it’s part of a connected digital system, not a patchwork of machines and spreadsheets. Tulip gives manufacturers that structure. The platform links packaging, quality, and compliance workflows so data moves cleanly through the process without constant IT intervention.

A Modular MES for Regulated Operations
Tulip’s MES is built from small, configurable components. You can start by digitizing a single line or by linking your printers and scanners to batch records. As requirements expand, new pieces can be added without rebuilding the system.

The platform supports 21 CFR Part 11, GMP, and similar global standards. Features like electronic signatures, audit trails, and user access controls are built in. Configuration replaces coding, which shortens deployment and keeps validation straightforward.

How It’s Used on the Floor

Pharmaceutical sites use Tulip to connect serialization to their wider production systems. A few typical setups include:

• Real-time monitoring of serialized units, with automatic checks when a scan fails

• Electronic batch records that include serialization steps and time-stamped approvals

• Direct connections from scanners, printers, and vision cameras to Tulip apps, removing the need for middleware

On most lines, operators run Tulip apps that verify every serialization event, tie it to the correct batch, and push the data into the record system. The information stays available for review or audit without manual file handling.

Compliance and Operational Gains
When serialization runs through Tulip, the benefits show up in daily work, not just during inspections.

• Fewer errors: Guided workflows help operators follow the right sequence and catch mistakes immediately.

• Faster audits: Every record is stored electronically and can be retrieved in seconds.

• Improved visibility: Real-time dashboards show the status of lines, batches, and exceptions so quality teams can act before deviations grow.

Scaling doesn’t require a rebuild. Because the platform is cloud-based, new lines or sites can be added with the same structure already validated elsewhere. That makes it easier to stay compliant as operations expand.

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!