The window for timely serialization compliance is closing in. Pharma companies, contract manufacturing organizations (CMOs) and contract packaging organizations (CPOs) may have breathed a sigh of relief last June, when the U.S. FDA announced a one-year postponement on enforcing the Drug Supply Chain Security Act (DSCSA), a regulation which, among other mandates, necessitates printing unique product identification codes on all Rx units of sale and homogenous cases distributed domestically. But that was then, and this is now—once again, there are mere months before the November 2018 enforcement deadline is upon us.

Smart pharma companies are seeking out partnerships with CMOs and CPOs who demonstrate serialization readiness. Those contract organizations offering serialization solutions that go beyond basic requirements are in the driver’s seat. Success lies in working with companies whose systems offer high capability, scalability and flexibility, and in turn, a high level of integration in terms of data exchange and process alignment.

The bottom line? Big Pharma companies will give preference to serialization management partners whose track and trace systems are robust and highly configurable—rather than restrictively remedial. Those same preferences will apply to the track and trace solutions of contract manufacturers and packagers.

Unique challenges
While pharma manufacturers face similar challenges to CMOs and CPOs, the situation is a bit more tangled for contract organizations. Considering the complexities of reporting to brand owners who have different standards based on differing, product-specific rules and regulations, you can see how difficulties are compounded. Comprehensive solutions need to address the needs of a quickly changing manufacturing and packaging environment.

As such, the need for next-level thinking becomes exceedingly important. As awareness grows of the complexities and interconnectivity of all players in the serialization process, the importance of choosing the right partner—one whose solutions offer modularity and flexibility—becomes paramount. And therein lies an enormous upside of the enforcement postponement: it has provided valuable extra time for all parties involved to look beyond short-term compliance needs and consider long-term solution viability.

Forward-thinking companies have come to understand that in order to assure long-term success, they need to implement flexible, hardware-agnostic serialization solutions that can adapt or scale-up to meet future track and trace mandates, as well as help improve business practices. For those who, until now, have been hurrying toward compliance, the postponement has afforded time to rethink the overall process and incorporate tools that can better utilize—for the sake of production improvements and personnel allocation—the troves of data generated by serialization mandates. This data can be mined and analyzed to have worth far beyond its primary purpose of tracking and storing for brand owner regulatory reporting.

Questions to ponder
In order to take full advantage of the DSCSA enforcement suspension, pharma companies, CMOs and CPOs must ask themselves several questions as they move toward implementing more comprehensive, beyond-compliance serialization systems.

Does my overall strategy meet my long-term needs?
The DSCSA postponement provides a chance for those spearheading serialization initiatives to reassess their overall strategy. For those companies who have been rushing toward compliance via the most basic, expedient routes available, the time is now for some honest soul-searching.

The big question to ask: Is the solution we have chosen to implement a marriage of convenience, or a truly happy one? Scenarios like these exemplify the adage that “speed kills.” Amidst the sprint to meet the original November 2017 deadline, did we feel the need to do some “settling” in terms of what was achievable in a fast-narrowing timeframe?

The most common flaw with many serialization solutions currently being embraced is that they are inherently shortsighted and, as a result, will be obsolete sooner rather than later. It is worth remembering that the initial DSCSA mandate for unit-level serialization will be followed, in subsequent years, by increasingly stringent requirements ending with full supply chain traceability in 2023.

Why invest in a technology that will need to be replaced in five years? The yearlong enforcement suspension gives pharma companies, CMOs and CPOs enough time to reimagine their serialization solutions into scalable systems that can address rolling deadlines with phased-in requirements, and there is no time like the present.

What have we learned since starting the serialization implementation process?
Fact: Having been charged with implementing a workable track & trace solution—and with the business’ entire viability at stake, no less—we know more about serialization now than when we first started out. The postponement gives us the opportunity to employ this newfound knowledge, and ask what we have learned since we began. What have we done correctly? What might we have done differently in hindsight? What improvements can be made going forward?

A real world example: One of our newest customers needed to add bundling operations on seven packaging lines. A huge problem arose when they realized that a few of the lines couldn’t be updated using the existing serialization solution they’d been utilizing. That’s alarmingly inadequate, and our customer was fortunate to have discovered this limitation early enough to correct it—an onerous exercise involving costly downtime and the requisite validation that any system used in the pharma industry must complete.

Another typical issue here lies with cyber-security. As we move toward enterprise-level serialization, solutions will need to be interconnected in a way that, in the age of “Internet of Things,” can expose vulnerabilities. As the widespread grief caused by the aptly named WannaCry ransomware attacks exemplifies, it’s become all too easy for criminals to take the cyber-backdoor into the networks of large companies and, once inside, wreak havoc.

For those pharma companies considering, for example, forgoing a previously planned transactional-only (Level 2) serialization system in favor of a more flexible enterprise-level solution (Level 4), the importance of proper encryption and virus protection cannot be overstated. Nor can the necessity of protected Cloud storage and secure data transmission between trading partners.

How can we implement solutions that lower operational costs and increase beyond-compliance ROI?
It’s inevitable. The vast majority of serialization solutions are going to reduce overall productivity. Whenever a new step is introduced to an extended process, such as pharma packaging, there will be some degree of slowdown.

The important question is this: To what degree? Too many pharma companies have realized too late that their chosen serialization solutions are significantly diminishing production output, and are expressing an urgent need to mitigate this drop-off.

Unfortunately, some are already in too deep, having installed on a multi-site, company-wide basis systems that, in order to be significantly improved upon in terms of speed or other matters of import, essentially need to be ripped out and replaced. That’s tens of millions of dollars in infrastructure alone—an investment simply not possible for many manufacturers.
To avoid this pitfall, here are two key buzz phrases: “hardware-agnostic solutions” and “beyond-compliance return on investment.”

Simply put, hardware-agnostic solutions are less likely to become obsolete, and are more suited to making adjustments as production needs change or evolve. A process as intricate as serialization requires an outsized number of components to “play nice” with each other; these sorts of ongoing transactional relationships are best mediated by software.

Beyond-compliance ROI alludes to ways of utilizing the massive amount of data generated by serialization efforts to improve business practices, including the potential to reduce or even eliminate production slowdown caused by the system’s line incorporation. Solutions now exist that open up new horizons beyond regulatory compliance in terms of data analysis and machine learning tools, among other capabilities.

In actuality, the data pharma companies are required to gather, store and report to regulatory authorities can be as valuable as they choose to make it. For example, tools exist that monitor overall equipment efficiency (OEE) to pinpoint potential production bottlenecks. Associated systems track and predict production scenarios that allow companies to allocate the proper personnel for specific projects, maximizing individual strengths while limiting unnecessary overtime. 

Conclusion
The DSCSA enforcement postponement gives pharma companies, CMOs and CPOs an opportunity to address both current and emerging regulations, while also minimizing impact on production processes and productivity. The time is now to move toward solutions that are flexible, scalable, and relatively painless to deploy. Often, this means selecting serialization management partners that offer hardware agnostic systems compatible with a wide range of equipment, and “smart factory” solutions that allow for data-driven business practice improvements that offer beyond-compliance ROI. 

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William Minaeff is Senior Project Director for Adents, a leading provider of serialization solutions for unique product identification and traceability. Adents serializes pharmaceutical products for Top 50 Global Pharma companies to help them and their contract manufacturing organizations (CMOs) adapt to market changes and comply with regulations on drug traceability. www.Adents.com.