Global pharma is teetering on the brink of a new world in which ground-breaking regulations impose strict serialization, traceability and verification obligations on the medicine supply chain. With deadlines for the adoption of DSCSA and FMD imminent—and similar legislation in other important regions just around the corner—it’s no surprise that companies are ramping up their efforts to assure regulatory compliance.

Pharma is in the jaws of change and no-one wants to get bitten. But perhaps, at times, companies’ emphasis is imbalanced. In some organizations, an understandable but blinkered focus on achieving compliance may be driving operations at the expense of a far more important attribute: quality. Many businesses are adopting compliance-first, or indeed compliance-only, approaches that concentrate solely on ensuring they do the bare minimum to meet regulatory requirements. They’re ticking a box. The most proactive companies, however, have taken a different approach: they’re not ticking the box, they’re thinking outside of it—by focusing on quality and long-term value. It’s the right way to go. Here’s why.

Serialization is much more than a rule to be obeyed, it’s a huge opportunity for industry. But seizing it requires a visionary approach. Pharmaceutical companies should look beyond the functional requirements of compliance and instead design ‘quality-first’ strategies that explore how serialization data can be leveraged to deliver long-term value. The potential is significant. With innovation and creative forward-thinking, future applications of serialization data could help transform old models of care. But the possibilities, which we’ll examine later, will only emerge through a focus on quality right from the outset when developing a serialization strategy and procuring the tools to deliver it.

So what does a quality-first approach look like? Here are the main considerations.

Key constituents of quality
The key to an effective serialization strategy is good technology. It’s why identifying the right partner and the best software is critical to success. However, 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.

A good technology partner will therefore seek to build quality into their product, their service and their culture. That focus on quality will show itself at all the key phases of the adoption life-cycle.

These typically include:

1. Defining requirements
This requires robust insight into regulatory requirements, the holistic needs of the market and, later in the development curve, the specific business needs of individual organizations. It requires deep, broad and sustained engagement. Clearly defined requirements outline the scope of the opportunity and provide the baseline for your approach. Getting them right is imperative.

2. Designing a solution
The development of core software, which will later be configured to meet individual business requirements, requires continuous collaboration with a broad set of stakeholders to ensure the solution marries regulatory needs with recognizable industry processes and unique business characteristics. It also requires a full appreciation of the nuances of the medicine supply chain. It’s an iterative process.

3. Characterizing processes
Process characterization is an essential component of a quality-first approach. It’s vital that all stakeholders have a deep understanding of the solution, how it operates and the areas where it may break. It’s only by understanding how all the individual components interact with each other that it’s possible to build an optimal system where everyone has confidence in the data that comes out of it.

4. Validating processes
This phase goes hand-in-hand with characterization. With data integrity the hallmark of a quality system, achieving it requires robust validation of the processes established in the characterization phase. The best systems adopt ISPE’s GAMP 5 guidance for validation as a minimum.

5. Monitoring
Quality-led systems build in automated, ‘always on’ monitoring so that organizations can detect and respond to problems or anomalies quickly and effectively.

Change control
These crucial aspects form a virtuous circle of quality that enables companies—through continuous monitoring and engagement—to take an agile, iterative and collaborative approach to system design and implementation. However, success is ultimately contingent upon having an effective change control system that allows companies to modify and maintain the quality of both the processes and the data within the system.

GMP guidelines stipulate that users of computer systems must always be in control, yet some multi-tenant serialization solutions impose software updates on users without warning, leaving them out of control. The impact on quality is substantial. Fundamentally, serialization depends on having accurate, secure and accessible data—as well as appropriate processes that can reliably and transparently accommodate change across a global organization. Insufficient change control can adversely impact performance in these key areas and significantly impair quality.

Why bother?
The value of working with a trusted partner that takes a quality-first approach to serialization cannot be overstated. The compliance benefits are obvious, but they’re the minimum requirement. The long-term advantages, which are dependent on designing a system that maximizes all the data flowing through it, extend far beyond satisfying regulations.
Serialization naturally introduces traceability to the medicine supply chain. However, this data could also be used to provide added value for pharma, providers and, crucially, patients. From a patient safety perspective, in addition to providing reassurance around the authenticity of medicines, it can help also accelerate and improve the granularity of product recalls—benefitting wholesalers, pharmacists and patients.

There’s also great potential to use serialization data to monitor and support patient compliance. Medicines adherence is a major, and costly, global challenge. Serialization could help companies identify poor adherence, as well as understand who is buying a product and where and how they’re using it. This powerful data can inform marketing strategy, improve patient support and stimulate patient-centered innovation.

The possibilities are boundless. Some of the best ideas are yet to be conceived. However, to be in with a chance of developing and exploiting them, pharmaceutical companies must seize the moment and take a long-term view on serialization. The potential benefits reinforce the importance of working with a trusted partner that takes a quality-first approach. An expert partner will work with you from the outset to help shape strategy and design solutions that provide value beyond compliance.

A quality ambition
Ultimately, the success of your serialization efforts all comes down to ambition. Are you simply looking for compliance or striving for something more? The answer is common sense. The long-term, quality-first approach is underscored by a profound logic: compliance is a natural by-product of quality-driven objectives, but the reverse is seldom true. If the limit of your ambition is compliance, you may never achieve a quality solution. But if your unwavering focus is on quality, you’ll always be compliant. That’s why, when it comes to serialization, it makes sense not to just tick the box, but to think outside of it. Aim for quality, and you’ll be a serial winner. 

---

Martin Van Trieste is the former chief quality officer for Amgen. In September 2018 he was named chief executive officer of Civica Rx, a new not-for-profit generic drug company set up to help patients by addressing shortages and high prices of lifesaving medications. Mr. Van Trieste has more than 35 years of experience in pharmaceuticals and currently sits on the board at supply chain solutions provider rfxcel in addition to serving as past chair of the Parenteral Drug Association’s (PDA) 2018 officers.