Executive takeaways
- Serialization is a regulatory requirement and a business asset: the Drug Supply Chain Security Act establishes the U.S. framework, but the same unit-level data improves authentication, supply chain visibility, and recalls.
- Authentication protects patients and the brand: a unique identifier on each saleable unit lets manufacturers detect and combat counterfeit and diverted product.
- The data is only as good as the systems behind it: serialization touches packaging, printing, vision, ERP, EPCIS, and warehouse systems, all of which must remain validated and under change control.
- Treat it as a quality program, not a one-time project: standards, trading-partner connections, and regulations evolve, so the supporting systems need ongoing governance.
The Drug Quality and Security Act (DQSA) was enacted on November 27, 2013. The DQSA calls for a 10 year implementation plan to track pharmaceuticals as they make their way from the manufacturer to a pharmacy.
But, there is more to the serialization regulations than compliance. Pharmaceutical companies will gain many internal benefits by adopting a serialization system.
What Pharmaceutical Serialization Actually Is
Serialization is the practice of assigning a unique identifier to each individual saleable unit of a drug product and capturing that identifier as the unit moves through the supply chain. In the United States this is anchored by Title II of the DQSA, the Drug Supply Chain Security Act (DSCSA), which directs the U.S. Food and Drug Administration (FDA) and the pharmaceutical supply chain toward an interoperable, electronic, package-level system for tracing prescription drugs. The serialized identifier typically combines a product code, a serial number, a lot or batch number, and an expiration date, encoded in a 2D data carrier on the package.
Most trading partners implement these identifiers using global standards from GS1, including the Global Trade Item Number (GTIN), a serialized GTIN (SGTIN) for the unit-level serial number, and Electronic Product Code Information Services (EPCIS) as the common language for exchanging event data such as commissioning, packing, shipping, and receiving. Standardized data is what allows a manufacturer, distributor, and dispenser to interpret the same event the same way.
Product Authentication
Serialization can prove a products authenticity, which means a manufacturer can detect and combat counterfeit products and ultimately protect their company brand.
Because each unit carries a unique serial number, a product presented for sale or return can be checked against what the manufacturer actually commissioned. Identifiers that are unknown, duplicated, or already decommissioned become signals of a suspect product. This unit-level verification supports the DSCSA expectation that trading partners be able to investigate and handle suspect and illegitimate product, and it gives brand-protection and quality teams concrete data to act on rather than anecdotal reports.
Coordination of Supply Chain Data
Manufacturers can get information about products as they move through the supply chain. Supply chain visibility can help a company control inventory and reduce costs. Manufacturers can also see the impact of supply chain disruptions.
When commissioning, aggregation, shipping, and receiving events are captured in a consistent EPCIS format, the resulting trail connects parent cases and pallets to the individual units inside them. That aggregation lets partners scan a single case and infer the units within it, reducing handling and reconciliation effort. The same connected data is what makes downstream interoperability and verification possible across distributors and dispensers.
How serialized data flows through the supply chain
- Commissioning: the manufacturer assigns and prints a unique serialized identifier on each saleable unit and records it as a created object.
- Aggregation: units are associated with the cases and pallets that contain them, creating a parent-child hierarchy.
- Shipping and receiving: trading partners exchange event data so each party can reconcile what was sent against what arrived.
- Verification: identifiers are checked for authenticity when product is dispensed, returned, or investigated as suspect.
- Decommissioning: identifiers are retired when product is dispensed, destroyed, or otherwise leaves the supply chain so they cannot be reused.
Efficient Recall Process
Manufacturers can conduct precise recalls by pinpointing locations that received the product in question.
Lot-level and unit-level data narrows a recall to the specific batches and shipment destinations affected, rather than forcing a broad sweep across the market. That precision shortens response time, limits disruption to product that is unaffected, and produces a clearer evidentiary record of which units were contained.
Grow Revenue
Reduce counterfeit activity that occurs when products are faked and diverted.
Counterfeiting and diversion erode revenue and trust. By making each unit verifiable and traceable, serialization reduces the room in which falsified product can circulate and helps protect legitimate sales channels and pricing integrity.
The serial number on a package is not the deliverable. The trustworthy, connected data behind it is what protects patients, the brand, and the bottom line.
Serialization Lives Inside a Larger Compliance Picture
Serialization rarely stands alone. The systems that generate, print, inspect, and exchange serialized data are typically GxP-relevant, which means they fall under expectations for validation, change control, and data integrity. The records these systems create are subject to electronic records and electronic signatures expectations under 21 CFR Part 11, so attributes such as audit trails, access control, and record accuracy matter as much as the encoded number itself. Maintaining data integrity across these connected systems is what makes serialized data defensible during an inspection or investigation.
Many of the same organizations face parallel identification programs on the device side, where Unique Device Identification (UDI) requirements and submissions to the FDA Global Unique Device Identification Database (GUDID) follow a comparable logic of unique, verifiable identifiers. The disciplines overlap: standardized identifiers, controlled data, and validated systems that keep that data trustworthy over time.
Validation and Governance Keep Serialized Data Trustworthy
A serialization program introduces or changes packaging, printing, vision inspection, warehouse, ERP, PLM, and EPCIS systems, plus the interfaces between them and external partners. Each of those changes needs to be qualified and kept under control so the data stays reliable as software is updated and trading-partner connections evolve. A risk-based Computer Software Assurance (CSA) approach helps teams focus testing effort where patient safety and data integrity are most at stake, while a validation lifecycle management mindset keeps systems in a controlled state rather than treating validation as a one-time event.
Because serialization depends on data exchanged with many external trading partners, it also intersects with broader governance concerns such as third-party risk management. The reliability of a manufacturers traceability data is only as strong as the partners and connections that contribute to it.
How USDM Can Help
USDM Life Sciences will help you assess, plan and execute the changes and enhancements necessary to meet these regulations. Our team of experts will assess your products, the markets where they are sold and determine an implementation strategy for the changes that need to be made. USDMs assessment methodology is extensive and includes the labels and packaging, the management of identification changes to each product, the changes to PLM, ERP, EPCIS and packaging systems, changes to printing, vision inspection and warehouse/inventory management systems and interfaces to foreign medical agency databases for pharmaceutical tracking. Also, USDM experts ensure that all changes and enhancements are implemented under the governing GMP regulations, under change control and validated prior to release for production.
Whether you are standing up serialization for the first time, connecting new trading partners, or maturing an existing program, USDM can help you align the technology, validation evidence, and governance so your serialized data stays compliant and useful. Contact USDM to discuss your serialization and traceability goals.
FAQ: Pharmaceutical Serialization
What is the difference between the DQSA and the DSCSA?
The Drug Quality and Security Act (DQSA) was enacted on November 27, 2013 and is the broader law. The Drug Supply Chain Security Act (DSCSA) is Title II of the DQSA and is the portion that lays out the multi-year plan to build an interoperable, electronic system for tracing prescription drugs through the U.S. supply chain.
How does serialization help with counterfeit drugs?
Each saleable unit carries a unique serial number that can be checked against what the manufacturer actually commissioned. Identifiers that are unknown, duplicated, or already decommissioned indicate a suspect product, giving manufacturers and trading partners a concrete way to detect and investigate counterfeit or diverted goods.
What systems are affected by a serialization program?
Serialization typically touches labeling and packaging, printing, vision inspection, warehouse and inventory management, ERP, PLM, and EPCIS systems, along with the interfaces that connect them to trading partners and external databases. These systems are generally GxP-relevant and need to be validated and managed under change control.
Is serialized data subject to data integrity and 21 CFR Part 11 expectations?
Yes. The records produced by serialization systems are electronic records, so attributes such as audit trails, access controls, and record accuracy under 21 CFR Part 11 apply, and the connected data must meet data integrity expectations to be defensible during inspections and investigations.
Is serialization only a compliance exercise?
No. Compliance is the floor. The same unit-level data delivers internal benefits including product authentication, better supply chain visibility and inventory control, faster and more precise recalls, and reduced counterfeit and diversion activity.