The Drug Supply Chain Security Act (DSCSA) and EU Falsified Medicines Directive (FMD) have forced the pharmaceutical industry to sharpen its focus on serialization, supply chain security and quality. The regulatory measures are aimed at preventing counterfeit products from infil-trating the supply chain—a problem that costs the industry almost $40 billion annually.

Despite the urgency from all segments of the pharma supply chain to meet various deadlines, many drug manufacturers are still behind schedule. Supply chain expert Tracelink predicted last year that as many as 400 contract manufacturing organizations (CMOs) would not be ready for the U.S. and EU serialization compliance deadlines. The firm said this equates to roughly 50 percent of CMOs in these regions, leaving many pharma firms without the support they need to meet the serialization deadlines. At the same time, research firm KPMG said in a recent report that more than 70 percent of manufacturers believed that serialization requirements would have a positive impact on their business processes.

In this issue we hear from Martin Van Trieste, the former chief quality officer for Amgen, cur-rent CEO of Civica Rx, and board member at supply chain solutions provider rfxcel talk about why a quality-first approach to serialization can deliver long-term value beyond compliance. In, “Serialization: Don’t Just Tick the Box, Think Outside Of It,” Mr. Van Trieste says the key to an effective serialization strategy is good technology and why identifying the right partner and the best software is critical to success. However, he says “there’s more to serialization than simply acquiring the basic functionality of track and trace. The design, configuration and implementation of a system will ultimately be the difference between an approach that’s content with compliance and one that’s striving for added-value far beyond it.”

We also hear from the serialization team at Bristol-Myers Squibb, led by Miguel Pitarch, the executive director of global serialization at the Big Pharma firm. In “Serialization Compliance,” the team talks about why automated data controls during packaging help improve compliance. “At Bristol-Myers Squibb we are implementing the same data reconciliation pro-cesses in all our packaging sites regardless of market. Our team has concluded that the benefits of standardizing operational processes, and implementing automated ‘checks’ in the recon-ciliation process to ensure data integrity far outweigh the temporary impact of making the changes.”

From a contract packager perspective, with Pieter Vercruysse, commercial director at Tjoapack and Geoff Lemin, production support and packaging technology manager for the Wasdell Group, we had to chance to talk about overcoming the challenges of implementing serialization. Click here to find out what they have to say about the considerations companies must make when implementing serialization capabilities across packaging lines.

Tracking and tracing drug products offers benefits beyond simply achieving compliance. More importantly, integrating serializition into operations allows for heightened transparency into a company’s inner workings, which ultimately enhances trust with partners and end-users, and benefits all stake holders along the pharma supply chain.


Tim Wright, Editor
twright@rodmanmedia.com