Pius Haas Jun 16, 2020 1:52:15 PM 10 min read

How to Manage Pharmatrack, Traceability and Serialization in the Pharmaceutical Industry

Learn how U-NICA helps manage the transition and business processes required to meet medical serialization standards.

Transitions in business models are inevitable, especially in our globally interconnected, technology-dependent era. Counterfeiting is one more pressure element that necessitates change, and pharma’s next big adaptation to that is a focus on product traceability through serialization.

It’s a long-established tracking process that has new standards to fight a new age of counterfeiting. Here are some examples of what global pharma regulations now expect and how U-NICA can help your supply chain meet these standards.

New traceability and serialization standards around the world

The goal of transitioning to a system that enables location and verification of medication throughout the pharma supply chain has become universal, and there are common themes in how it’s being implemented between countries. Let’s take three locations — the United States, the EU and China — as examples.

U.S. pharma management measures stem from the Drug Quality and Security Act of November 27, 2013. Also called the Pharma Track and Trace Bill, this federal law has two main goals: To protect traditional pharmacies and clarify laws related to human drug compounding and to strengthen the prescription drug supply chain to protect against counterfeiters.

Implementation is ongoing, and 2020 is a crucial point in the management process. By the end of this year, American pharma dispensers are legally required to accept or distribute only prescription drug products that incorporate a product identifier. Serialization numbers proving product origin, production batch and expiry data are the primary means to satisfy these requirements, but U-NICA can complement this for superior product and brand protection.

Enforcement in the EU

The EU’s Directive 2011/62/EU, also called the Falsified Medicines Directive, was enacted to lay down rules for the management, manufacturing, importing, bringing to market and wholesale distribution of medicinal products. It was a response to the alarming increase of such products in the EU with falsified information regarding their identity, history or source, some of which posed a deadly threat to human health.

The Directive acknowledged that counterfeit medicines also reach patients via the legal pharma supply chain. As the first tracking management step, the EU made unique, tamper-proof identifiers an obligatory element of all medicinal packaging as of February 2019. 

Traceability standards in China 

China’s solution to pharmatrack and traceability was also serialization of 20 digits printed on both primary and secondary packaging as well as batch pallets. (Clearly, serialization is a favored method because these very different countries chose a similar global practice.)

The problem is that serialization alone is not enough. These long numerical sequences are sometimes scanned and sometimes manually entered, but each method is highly vulnerable to machine and human error. A single digit incorrectly entered could invalidate a legitimate batch of medication or even worse, validate a batch of counterfeits that then go to market.

Serialization also requires that every stage of the pharma supply chain, sometimes 10 nodes deep, is able to rely on the data it’s receiving. While their national governments and regulatory bodies can guide pharma producers on serialization procedures, pharma producers themselves need a partner who can make the transition to greater traceability compliance simple, efficient and cost-effective.

Cost and staff training are common barriers to more immediate and wide-ranging adoption of serialization. Manufacturers fear they’ll need expensive new equipment or must disrupt their current production process with new hardware or staff education breaks.

Not so with U-NICA. We can integrate our solutions seamlessly while promoting company-wide understanding of security to create a cross-functional anti-counterfeiting team.

04_Blog_Content_How_to_Manage_Pharmatrack_Traceability_Serialization_Pharmaceutical_Industry_01

How U-NICA solutions help global pharma manage traceability

We provide innovative and robust options that meet the necessary global standards of being inarguable tamper-proof identifiers. By integrating these identifiers seamlessly into your current production models, U-NICA enables your company to cost-effectively manage the pharma supply chain beyond serialization and ensure regulatory compliance, brand and product protection, and patient safety.

Our scryptoTRACE®  solution is the foundation for brand protection architecture. It’s flexible because it can integrate with other enterprise systems and new or foreign marking and recognition technologies. It’s fully scalable with a smartphone app for product verification, authentication and user engagement. This option also provides a flow of real-time anti-counterfeiting information to enable faster security decisions.

scryptoTRACE® attacks counterfeiting from two directions. First, it provides an easy smartphone app that allows consumers to identify genuine products anywhere at any time. That app collects information on counterfeit activity from around the world, allowing brand owners and law enforcement to track, identify, apprehend and press charges against the criminals.

plastoTRACETM brings invisible trademark protection for pharmaceutical products with security depths ranging from overt to covert and forensic. This provides simple, clear authentication that’s customizable and can be made machine-readable for in-process tracking. These taggants and inks are tamper-proof because only the manufacturer and approved supply chain partners know they exist. 

U-NICA solution introduces holographic elements tailored uniquely to your product and embedded directly into the product design, which enables cost-effective lifetime authenticity checks. The non-transferable nature of this solution makes it more than compliant with the pharma industry’s tamper-proof requirements.

Ease the transition to traceability with U-NICA

We appreciate that change can be confusing. Each of our clients becomes a part of the U-NICA Protection Circle®, which was developed to collect, analyze and share information on how products move in their specific markets and to study regional and product-specific risks.

This constantly evolving knowledge base combined with our practical pharmatrack solutions powerfully compliments serialization and give manufacturers, staff and partners the tools they need to manage a holistic anti-counterfeit approach.

Any pharma company reluctant to make tracking changes due to money and time concerns must remember that counterfeiters, government penalties and consumer lawsuits will be guaranteed impacts on future business. U-NICA helps ensure none of these happen to you.

U-NICA is a team with a single purpose: supporting you in the fight to protect your brand’s integrity and value. Our staff operates globally and partners with universities and agencies to deliver the future of brand protection. Connect with me for more information on our constantly evolving open solution suite.

avatar

Pius Haas

Has more than 30 years of experience in IT / IS management of strategic developments and business areas. Proven history as innovator, entrepreneur and business pioneer, able to launch, develop and implement tailor-made programs for customer needs in key industries. Has the ability to drive the conception, design and implementation of leading-edge technology solutions while motivating and supporting employees and partners to achieve performance goals with a single mission.

COMMENTS