Cracking the Code

The FDA has given pharma businesses in the US a decade to come into full compliance with the Drug Supply Chain Security Act (DSCSA), and it will
come into force in November 2024. © Best – stock.adobe.com

Serialization that powers the future of pharma.

By David Gonzalez, Technical Account Manager, MM Packaging

For today’s leading pharmaceutical businesses, coding technologies, including serialization and pre-serialization, have never been more important – or as accessible.

Throughout the global pharma industry, serialization and pre-serialization are pivotal advancements reshaping the landscape of drug manufacturing, distribution and safety. The coding and marking systems industry is growing as a result, expected to reach a total value of $6 billion by 2030, according to data published by Research & Markets. Due to a focused push on safety, security and accountability, as well as expanding regulatory and legislative demands, it’s no surprise that the pharma industry is embracing the advantages of coding technology.

Understanding Serialization

Serialization is the process of assigning a unique identifier or code to each individual unit of a pharmaceutical product, typically at the filled packaging level, before distribution. This identifier is usually in the form of a barcode or data matrix, and today’s technology means it can contain a wide range of crucial information, such as Global Trade Item Number (GTIN), product origin, validating authenticity, batch number, expiry date and other relevant data points.

By implementing serialization as part of their packaging designs, pharmaceutical companies can track and trace each pack as a unique data node throughout the supply chain, from manufacturing to distribution to dispensing. Those that have been working in the pharma industry for a long time will understand that this level of traceability is unprecedented. It not only enhances supply chain security but also enables rapid and targeted recalls in the event of quality issues or safety concerns, ultimately safeguarding patient health and supporting regulatory compliance.

The Benefits of Pre-serialization

Pre-serialization, on the other hand, involves the coding of pharmaceutical packaging materials before they are filled with product. This process allows for the application of unique identifiers or codes to packaging components such as cartons, prior to their integration into the production line. By pre-serializing packaging materials, a process that is usually separate to packaging production and is often outsourced, pharmaceutical companies can streamline their manufacturing processes, reducing downtime through the filling and distributing process.

Additionally, pre-serialization services enable pharmaceutical companies to outsource coding tasks, particularly for small orders or products with specific coding technology requirements that would otherwise need to be outsourced, thereby optimizing operational efficiency and cost-effectiveness.

As the pharma industry is battling challenges such as the escalation in counterfeiting, safety and traceability remain paramount and serialization and pre-serialization technologies play a crucial role.

Escalating Legislation

International pharmaceutical regulations are increasingly mandating serialization as a critical component of the supply chain, aiming to enhance patient safety and combat the proliferation of counterfeit drugs, which the World Health Organization (WHO) reports may account for as much as 10% of the pharma market in certain regions around the globe.

Examples of such regulations include the European Union’s Falsified Medicines Directive (EU FMD) and China’s Drug Administration Law, both of which require pharmaceutical products to be serialized to enable traceability and authentication throughout the supply chain. In the United States, the Food & Drug Administration’s (FDA) Drug Supply Chain Security Act (DSCSA) stands as a prominent example of serialization becoming mandatory. Enacted in 2013, the DSCSA aims to protect public health by establishing requirements for the secure tracking and tracing of prescription drugs as they move through the supply chain.

The DSCSA mandates serialization by requiring pharmaceutical manufacturers, wholesalers, and dispensers to serialize prescription drug products with a unique product identifier (UPI). This UPI barcode must contain vital information such as the product’s serial number, lot number, and expiration date. The FDA had given pharma businesses in the US a decade to come into full compliance, which will now come into force in November 2024.

By implementing serialization, the DSCSA aims to prevent counterfeit, stolen, or otherwise harmful drugs from entering the US drug supply chain, thereby safeguarding patient health. Furthermore, serialization under the DSCSA facilitates the rapid identification and recall of suspect or illegitimate products, minimizing the potential risks associated with counterfeit medications. Overall, the DSCSA’s serialization requirements serve as a cornerstone of efforts to ensure the integrity and security of the pharmaceutical supply chain in the United States.

Innovation is Key

By partnering with industry experts, pharmaceutical companies gain access to innovative pre-serialization and serialization capabilities, and tap into extensive local market knowledge. For example, we have introduced a proprietary coating that is applied to cartons or labels. The solution uses a CO₂, fiber or UV laser to activate proprietary color-changing coating technology, producing accurate high-contrast patterns.

Offering cleaner code registration than typical laser based systems, this solution provides secure coding suited to Optical Character Recognition (OCR) vision systems for pharmaceutical packaging, safeguarding products against counterfeit threats while enhancing supply chain security. This innovative technology also ensures that codes remain both human and machine-readable, through even the most complex logistical operations.

In addition, pre-serialization services can deliver unparalleled flexibility and efficiency for pharmaceutical companies. With our in-house coding capabilities, we alleviate the burden on our customers by handling coding tasks for small orders and uncommon coding requirements. For example, we are able to code to international standards, including global GS1, as well as standards required by American, Russian and Chinese regulations.

Navigating Challenges

By outsourcing serialization and pre-serialization, pharmaceutical companies can streamline their operations, reduce costs and focus on their core competencies. The right packaging partner can empower pharmaceutical companies to navigate regulatory challenges with confidence, delivering serialization and pre-serialization solutions designed to meet the highest standards of quality, reliability and compliance.

As the pharmaceutical industry continues to evolve, it is important to partner with organizations that are committed to driving innovation and delivering value to customers. It’s clear that the rise of serialization and pre-serialization technologies in response to escalating global challenges is not going to slow down for the foreseeable future. These technologies are indispensable tools in today’s pharma sector, enabling enhanced safety, traceability, and efficiency. With an experienced team as a trusted partner, pharmaceutical companies can leverage these technologies to meet regulatory requirements, protect their products, and ensure the wellbeing of patients worldwide.

About the Author

David Gonzalez is a Technical Account Manager with MM Packaging. Together with their customers, MM Packaging is supercharging the future of pharma tech and advancing towards a safer and more secure pharmaceutical supply chain. MM Packaging is a division of MM Group and is a leading global producer of secondary packaging for industries including pharmaceutical and healthcare. Operating 64 sites in 24 countries, with 28 sites dedicated to pharma and healthcare, the business serves more than 800 companies worldwide with high quality folding boxes, leaflets, labels and booklets. Learn more at www.mm-packaging.com.