In the complex world of pharmaceutical manufacturing and distribution, ensuring product safety and integrity goes far beyond the medicine itself. It demands a rigorous system to track, verify and trust every single unit throughout its journey from the production line to the patient’s hands. At Systech, we understand that achieving this level of confidence isn’t just about ticking an IT compliance box. Many pure track-and-trace vendors may label themselves as “serialization providers,” but without true operating-technology capabilities, they offer only one piece of a much larger, multifaceted solution.

By contrast, Systech delivers end-to-end hardware and software that seamlessly integrates every step of the packaging and supply chain. This integrated approach is essential for achieving true supply-chain confidence and meeting the stringent global regulations, including the U.S. Drug Supply Chain Security Act (DSCSA) and the EU Falsified Medicines Directive (EU FMD). In this first installment of our series, we’ll lay the groundwork by defining serialization, exploring its critical components, and explaining why it forms the indispensable foundation for a secure pharmaceutical supply chain.

What is serialization? The digital fingerprint

At its core, serialization is the process of assigning a unique identifier (serial number) to each saleable unit of a pharmaceutical product. Think of it as giving every single carton, vial or blister pack its own unique “digital fingerprint.” This unique ID, often encoded in a 2D Datamatrix barcode, is not just a random number. It ties the physical unit back to crucial product data, including:

• Global Trade Item Number (GTIN): A globally unique product identifier.
• Lot number: Identifies the specific batch the product belongs to.
• Expiration date: Crucial for managing product shelf life.

By establishing this individual identity, serialization is the first and most fundamental step in preventing counterfeit drugs from infiltrating the legitimate supply chain. It provides the granular detail needed for granular tracking and verification.

The operational heart of serialization: Level 3 systems and beyond

The process of associating a serial number with a physical unit begins at the packaging site, orchestrated by a Level 3 (L3) solution. This L3 system plays a pivotal role:

• Work order management: It receives production work orders, typically from an Enterprise Resource Planning (ERP) system, and assigns them to specific packaging lines.
• Data collection and audit Trails: It collects vital data from the production lines, including serialized codes and comprehensive audit trails for every packaged unit.
• Orchestration with Line-Level systems: The L3 system communicates seamlessly with:
  • Device level (L1) systems: These manage printing and vision inspection based on print recipes provided by L3. They are responsible for precisely applying the serial numbers to the packaging.
  • Line level (L2) systems: These ensure that the vast variety of packaging controllers and equipment (e.g., cartoners, case packers) can be communicated with. L2 enforces specific workflows communicated by L3, manages material rejection based on verification failures (e.g., unreadable barcodes) and integrates with diverse packaging machinery.

The sophistication of this multi-level communication is paramount. As each packaging line can be used for different products, robust shared master data between L1, L2 and L3 is essential. This standardized information ensures consistency and avoids significant challenges in “mix and match” environments. Shared master data typically includes:

• Product identifiers: GTINs, batch numbers and other unique product codes.
• Packaging hierarchies: Definitions of how products are grouped (e.g., units per carton, cartons per case).
• Serialization parameters: Code formats, serial number ranges and expiration date logic.
• Print templates & Label layouts: Ensuring correct information in the required format.
• Validation rules: For print quality, barcode readability, and handling reworks or rejects.
• Device-specific configurations (“Recipes”): Guiding how printers, scanners, and other equipment operate for each product.

By sharing this crucial data across all system levels, manufacturers significantly reduce errors, enable faster changeovers between products and maintain strict compliance with global traceability requirements.

Global mandates for serialization

The foundational requirement of serialization is reflected in numerous regional and country-specific pharmaceutical compliance regimes worldwide. These include:

• DSCSA (Drug Supply Chain Security Act): The primary U.S. regulation mandating a serialized supply chain.
• EU FMD (European Union Falsified Medicines Directive): Requires unique identifiers and anti-tamper devices on prescription drug packaging across the EU.
• ANVISA (Agência Nacional de Vigilância Sanitária): Brazil’s health surveillance agency with its own serialization requirements.
• SFDA (Saudi Food and Drug Authority): Saudi Arabia’s regulatory body with serialization mandates.

These regulations universally start with the imperative to associate a serial number with a physical unit of a package at the manufacturing and packaging site.

The Systech difference: Full-stack serialization

It’s critical to understand the distinction between vendors who offer a full-stack L1-L5 solution (covering Device, Line, Site, Enterprise, and Partner Integration levels) and those who provide only L4-L5 traceability and partner integration.

Without integrated packaging line capabilities – such as on-line vision inspection for quality control, unit, batch, and lot level line control recipe enforcement, secure print and verification enabled high-speed vision equipment, seamless line controller integrations, and real-time data capture – what you end up with is merely an application software layer that generates codes. While this might suffice for a “virtual” pharmaceutical company that outsources all manufacturing and packaging, it falls short for actual manufacturers.

Systech’s commitment to delivering a comprehensive, end-to-end hardware and software solution ensures that your serialization process is not just a digital concept but a physically verified reality at the source. This robust, integrated approach is the bedrock upon which true supply chain integrity is built.

Stay tuned for Part 2 of our series, where we will explore aggregation – how these individual serialized units are grouped to streamline operations and further enhance traceability.

For help with finding your exact solution to your serialization needs, explore our Product Finder now!