Getting serious about serialization
The deadline for implementing serialization is rapidly approaching in the US and the European Union (EU)’s Falsified Medicines Directive (FMD) comes into action in February of next year. As a result, preparations for the process on both sides of the Atlantic need to be well advanced.
Testing on a national scale has already begun in several countries across Europe, with Ireland having conducted a pilot to determine how prepared the country’s system is when the FMD begins.
As the demand from within the industry preparing for the deadlines increases, a number of companies that offer track and trace services are expanding rapidly to cope.
With the US serialization deadline just one month away, in-PharmaTechnologist (IPT) spoke to Jack Tarkoff (JT), co-founder and chief strategy officer of rfxcel, about the challenges the deadline poses to the industry, and how adapting quickly is in everyone’s best interests.
IPT: What are the major challenges facing the pharma supply chain at present?
JT: Companies are focused on bringing their supply chains into compliance with domestic and international regulations. The global markets demand supply chains be nimble and shift based on where products are being sold. In addition, regulations are demanding tighter controls to prevent contamination and counterfeit drugs. This is a huge investment for pharma – pharma must not only comply but also implement solutions that help them extract value.
IPT: How well prepared are companies for the regulatory requirements of serialization?
JT: Despite the proximity of regulatory deadlines (Drug Supply Chain Security Act in November 2018, and EU FMD, February 2019), a surprising number of companies have not yet established the infrastructure and processes required for serialization. While it is not unusual for organizations to wait as long as possible before adapting operations to meet compliance obligations, it’s easy to underestimate the complexity of adding serialization capabilities to operations.
IPT: Working with those preparing for serialization, what has been the most common issue that clients have faced preparing for EU and US deadlines?
JT: Pharmaceutical companies must understand the laws, requirements, and the associated responsibilities of all parties in their partner networks. In addition, they must map their entire supply chain operations to systems to allow for visibility, collaboration, and agile workflow across a broad end-to-end process. It isn’t easy, it takes time, knowledge and expertise. Finding the right partner to expedite and implement systems, processes, and onboard partners to get them to go-live via the shortest, safest route is the most common issue.
In addition to meeting regulatory deadlines, smart pharma is looking for ways to extract value. Regulatory requirements are driving serialization at the lot and unit levels – this allows for tremendous value if companies look to build value long-term in their regulatory investments.
IPT: What kind of value can be extracted from the investment?
JT: Full track and trace capabilities can empower manufacturers, wholesalers, and dispensers to manage stock control and inventory more efficiently. This reinforces patient safety and helps businesses maintain profitability with better, real-time analytics. Crucially, it provides added value beyond regulatory requirements.
With a good end-to-end solution, and collaborative business partners, manufacturers can benefit from real-time analytics of performance across their partner network. This can provide greater visibility into product supply chain costs; immediate course correction; better understanding of product placement; and, inventory levels for just in time delivery.
IPT: How has rfxcel worked to provide technology that will ease the serialization process?
JT: Demands to track pharmaceutical products down to the lot and unit level has provided rfxcel the opportunity to pair serialization (product labels) with sensor (rfxcel Environmental Monitoring rEM) technology to track products in real time. Providing visibility into all aspects of the supply chain and the health of the products, as well as disruptions to shipments or diversion. rEM provides real-time tracking of products tied to product lines and serial numbers with real-time feedback like light exposure, tilt, temperature, geofencing, real-time route correction.
Jack Tarkoff is the chief strategy officer and co-founder of rfxcel. As a leader at rfxcel, Jack drives innovative efforts to build track and trace solutions that span industries.