Serialization in Pharma: Driving Compliance, Safety, and Traceability

Overview: Serialization in pharma has become the framework that supports traceability and regulatory alignment across the supply chain. By linking each product to a verifiable digital identity and sharing data through EPCIS standards, companies meet DSCSA requirements, reduce counterfeit risk, and maintain full visibility from manufacturing to dispensing.

How Pharmaceutical Serialization Connects Compliance and Supply Chain Trust

Every prescription medicine passes through a long chain of manufacturers, packagers, distributors, and dispensers. Tracking each step accurately keeps the supply chain secure and verifiable. Serialization in pharma assigns every product a unique digital identity that links packaging data to regulatory and partner systems.

Serialization supports two core objectives:

• Regulatory compliance under DSCSA and global traceability mandates.
• Product safety through detection of counterfeit or diverted goods.

When paired with EPCIS data exchange, serialization enables transparent, interoperable tracking across the entire pharmaceutical network—ensuring that every package can be traced back to a verified source.

How Serialization Works Across the Pharmaceutical Supply Chain

Pharmaceutical serialization begins during packaging, when a manufacturer assigns each saleable unit a unique serial number—typically encoded in a GS1 DataMatrix barcode.

That number is paired with product data such as the National Drug Code (NDC), lot number, and expiration date, forming a complete product identifier.

At each stage—commissioning, aggregation, shipment, and receipt—event data is recorded and transmitted using standardized formats such as the EPCIS standard developed by GS1. The result is a verifiable, end-to-end record of product movement.

Common stages of serialization include:

• Commissioning: Assigning serial numbers and linking them to product data.
• Aggregation: Building parent–child relationships between individual units, cases, and pallets.
• Shipment recording: Capturing EPCIS events that document the movement of serialized products.
• Verification and receipt: Confirming that products and serials match what was shipped.

Each step produces structured data that can be shared with trading partners and regulatory authorities as proof of compliance.

Regulatory Drivers for Serialization in Pharma

DSCSA and Interoperable Traceability

The Drug Supply Chain Security Act (DSCSA), enacted in 2013, mandates electronic traceability of prescription drugs across the U.S. supply chain. Earlier phases required serialization and product verification; the current phase emphasizes interoperable data exchange between trading partners.

That exchange relies on EPCIS files, which describe packaging and movement events in a standardized digital format.

By 2025, all DSCSA participants—manufacturers, repackagers, distributors, and dispensers—must exchange these files to demonstrate compliance. Serialization software capable of managing EPCIS data ensures that every serial number, transaction, and verification event meets DSCSA requirements and can be retrieved for audits.

Global Regulations and Market Expansion

Beyond the United States, more than 40 countries have adopted serialization mandates to prevent counterfeiting and diversion.

The European Union’s Falsified Medicines Directive (FMD), Brazil’s ANVISA, and India’s DGFT programs all depend on serialized identifiers to secure domestic and export markets. A single, interoperable serialization platform allows pharmaceutical companies to comply across multiple jurisdictions while maintaining data integrity and consistency.

Benefits of Serialization Beyond Compliance

Regulatory adherence may be the original purpose, but serialization now supports broader operational goals. Companies with mature serialization programs gain measurable advantages in efficiency and transparency.

Key benefits include:

• Accelerated recalls: Serialized data isolates affected lots instantly, minimizing waste and patient risk.
• Supply chain visibility: EPCIS events expose bottlenecks, delays, and potential diversion points.
• Authentication and brand protection: Serialized identifiers enable product verification at any point in distribution.
• Data-driven insight: Serialization data supports demand forecasting and quality-control analysis.

Serialization also builds public confidence by ensuring that every medicine dispensed can be traced back to a verified source.

Challenges in Implementing Serialization

Even experienced pharmaceutical manufacturers encounter obstacles when advancing serialization capabilities.

Common challenges include:

• System integration: Legacy packaging or ERP systems may lack EPCIS compatibility.
• Data quality: Incomplete or inconsistent serial data can cause EPCIS file rejections.
• Partner readiness: Trading partners may be on different EPCIS versions or data formats.
• Scalability: High transaction volumes require robust databases and automated validation tools.
• Regulatory variation: Requirements differ across markets, demanding flexible configuration.

Successful programs address these challenges through standardized data governance, validated interfaces, and ongoing coordination with trading partners.

How Serialization Software Streamlines DSCSA Compliance

Serialization software connects production, warehousing, and distribution systems to maintain accurate, compliant product data. The right platform manages every step—from serial-number assignment to EPCIS file exchange—while ensuring that event data remains accessible and audit-ready.

EPCIS Data Management and Exchange

Software automates the creation and validation of EPCIS events. Each transaction is structured according to GS1 schema and transmitted securely through channels such as AS2 or HTTPS. Error handling and reporting features reduce manual rework and accelerate partner data exchange.

Aggregation and Traceability Control

Serialization systems maintain parent–child hierarchies across packaging levels, allowing full traceability from pallet to individual package. During a recall or investigation, those hierarchies make it possible to isolate specific serials without interrupting broader distribution.

Data Governance and Secure Storage

Regulatory compliance depends on reliable access to historical data. Modern serialization software uses controlled access, encryption, and automated backups to preserve EPCIS event records for mandated retention periods.

Case Example: Serialization Implementation for a Contract Manufacturer

Covectra recently supported a mid-size pharmaceutical contract manufacturer developing serialization capabilities to meet DSCSA requirements for multiple brand-owner customers. The company needed a flexible, cost-effective approach that could be deployed quickly across manual packaging lines.

Covectra delivered an integrated, turnkey serialization system along with a ten-month expansion plan for additional lines. The project included deployment of Covectra’s AuthentiTrack Cloud Level 5 database for customers who required a complete end-to-end solution. For brand owners already using Level 5 systems, Covectra provided a secure gateway for transferring data between the contract manufacturer and the brand owners’ traceability databases.

The result was a scalable compliance framework that enabled the manufacturer to meet diverse customer requirements while maintaining DSCSA alignment.

Future Trends in Pharmaceutical Serialization

Serialization continues to evolve beyond static data exchange. Several emerging developments are reshaping how companies approach traceability:

• EPCIS 2.0 adoption: The latest version introduces JSON-based data sharing and improved real-time visibility, simplifying system integration.
• Global data harmonization: Initiatives led by GS1 and the World Health Organization aim to align serialization frameworks across regions.
• Advanced analytics: Companies are beginning to use serialization data to detect distribution anomalies and optimize inventory planning.
• Digital authentication: Serialization combined with mobile verification tools enables field-level counterfeit detection.

As traceability technologies expand, serialization remains the structure connecting regulatory requirements with operational insight.

FAQs: Serialization in Pharma, DSCSA, and EPCIS

What does serialization mean in pharma?

Serialization assigns a unique identifier to each saleable unit of a pharmaceutical product, enabling traceability and regulatory compliance throughout the supply chain.

How does serialization support DSCSA compliance?

It provides the serial data required to create EPCIS files and share transaction information between trading partners, ensuring electronic, interoperable traceability.

What is the role of EPCIS in pharmaceutical serialization?

EPCIS defines how event data—such as packaging, shipping, and receiving—is structured and exchanged, allowing systems from different organizations to interpret product movements consistently.
Source: GS1.org – EPCIS Standard

How does serialization improve product safety?

Serialized identifiers prevent counterfeit products from entering legitimate distribution channels and enable targeted recalls of affected lots.

Can serialization data enhance business operations?

Yes. Aggregated serialization data provides insights into supply-chain efficiency, shipment accuracy, and product demand trends.

Advance Traceability with Proven Serialization Software

Covectra helps pharmaceutical companies capture and share serialized data securely across trading partners, maintaining traceability and compliance readiness. Contact Covectra to discuss how our pharmaceutical serialization and compliance solutions can help you achieve your goals.

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