Pharmaceutical Serialization Requirements
The US and other countries are now mandating product serialization requirements and track and trace systems in pharmaceutical supply chains to combat the growing problem of counterfeit medicines. In the US, the Drug Supply Chain Security Act (DSCSA) is helping to establish a new system for the traceability of prescription drugs that will be phased in through a series of evolving requirements. It mandates pharmaceutical serialization requirements for drug manufacturers and repackagers with the aim of enhancing pharmaceutical supply chain security.
It is expected that the US pharmaceutical industry will have a track and trace system in place by 2023 to enable the tracking of an individual unit of drug product through the supply chain and back to the original manufacturer. Pharmaceutical serialization requirements are the first step in making every drug product traceable, thereby strengthening the integrity of the global medical supply chain and protecting the patients that depend on it.
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Pharmaceutical serialization requirements and regulations
Pharma serialization is carried out by affixing a unique product identifier or serial number to packages or cases of drug products. In the US, pharmaceutical serialization requirements apply to drug manufacturers, repackagers, wholesale distributors, and dispensers. Currently, manufacturers and repackagers are required to affix a product identifier to each individual package of prescription medication and homogeneous case of prescription drug product or repackaged drug product. In the US, EU, UK, Iceland, Norway, and Switzerland, a Data Matrix, or 2D barcode, containing the product identifier and other data is used to serialize pharmaceutical products.
The regulations of the DSCSA mandate that all participants in the US drug supply chain—including contract manufacturers and third-party logistics providers—exchange compliance documentation (Transaction Information, Transaction History, and Transaction Statement) with their trading partners and store the information/serialization data in a readily available location for a period of at least six years from the transaction date. All players in the pharma supply chain must also put in place systems and processes to verify the accuracy of the documentation they receive and, if requested, the product identifier of suspect products.
In the EU, pharmaceutical serialization requirements mandate that product authentication be carried out at the point of dispensation. Over 36 countries including Egypt and Russia now have pharmaceutical serialization, track and trace, and product authentication compliance requirements in place. And in many other countries, legislation for pharmaceutical serialization and track and trace systems is being drafted or in the planning stage.
Benefits of achieving compliance with pharmaceutical serialization requirements
While achieving compliance with globally unaligned and evolving pharmaceutical serialization requirements can be challenging for companies working in different parts of the world, the benefits of compliance are clear. Firms that comply with serialization regulations not only avoid legal problems and but help protect global populations from the threat of counterfeit, stolen, and tainted medicines.
This data can be analyzed and used to enhance supply chain and sales visibility, contributing to improved demand forecasting and inventory management, more accurate order fulfillment and shipping, and more effective and efficient product recall management and returns processing. Serialization data can be used to inform pharmaceutical quality control and create a more robust pharmaceutical quality system. It can also be used to streamline and automate procurement, invoicing, warehouse performance analysis, and other processes involved in the pharma supply chain.
Pharmaceutical serialization requirements have introduced unprecedented challenges for companies in the areas of data exchange, storage, and management. This is why forward-thinking firms are investing in technological solutions that can help them more easily generate, capture, verify, manage, share, and report on serialization data. They are leveraging powerful pharmaceutical supply chain solutions that can help them not only ensure compliance with pharmaceutical serialization requirements but also maximize the value of their serialization-related investments.
Serialization data is actually a rich repository of information that can be mined to provide business value and insight. The actionable insights obtained from this data can be used to improve transparency and efficiency, promote data-driven and demand-aware decision making, and enhance responsiveness across the end-to-end pharma value chain. With the help of technology, pharma serialization compliance becomes less of a burden and more of an enabler of long-term success.
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Driving operational excellence with pharmaceutical serialization data
Serialized Product Intelligence is a fully automated, self-service analytics application that is helping TraceLink customers increase their ROI from serialization compliance-related investments. Built on TraceLink's Digital Network Platform, the only digital supply network platform designed to support the needs of pharmaceutical firms, it enables companies to proactively aggregate and analyze their serialization data at various levels of granularity.
Organizations can use it drive compliance with global pharmaceutical serialization requirements and leverage their serialization data to better monitor serialized operations, detect and resolve supply chain disruptions or compliance issues faster, and improve on-time delivery of medicines. Users get end-to-end visibility into serialization processes, automated reporting that saves time and expense, and access to a fully integrated digital supply network platform that they and their trading partners can use to create new processes that produce actionable intelligence, deliver business value, and drive operational excellence across the global pharma value chain.
Pharmaceutical Serialization Requirements FAQs
What are the main objectives of the DSCSA?
Its main purpose is to strengthen the security of the US drug distribution supply chain by mandating pharmaceutical serialization requirements and establishing a national pharmaceutical track and trace system. The goal is to minimize or reduce vulnerabilities in the drug supply chain by developing a digitized and interoperable system that improves the traceability of prescription drugs and enables supply chain partners to verify the legitimacy of individual drug products.
What is the purpose of serialization requirements in the pharmaceutical industry?
Serialization requirements make it easier for participants in the pharmaceutical industry to determine the authenticity of drug products, identify and remove illegitimate or expired products from the supply chain, and accelerate the processing of drug product recalls.
How can the pharmaceutical industry use serialization data?
Partners in the pharma supply chain can aggregate and analyze serialization data to increase supply chain visibility and efficiency, accelerate detection and resolution of potential supply chain disruption or compliance issues, and enhance supply chain responsiveness and agility.