GSK's Global Strategy For Serialization
By Louis Garguilo, Chief Editor, Outsourced Pharma
The biopharma industry throws around the term “serialization” as if it were some global singularity to be tamed by an equally universal, technical silver bullet.
Terry Crawford, Serialization Technical Manager of GSK – and former serialization support specialist at Zenith Technologies – quickly shoots down that type of talk. “We have new regulations from various country and regional markets coming at us all the time,” he says. “Russia has a regulation that isn’t quite like Jordan’s. Differences are evident in the Arab Emirates. China changed their regulations, and Brazil, too, is another recent example we’ll need to adjust to.”
The list goes on. And as his title suggests, Crawford’s knee-deep in ensuring GSK and its packaging partners meet already-in-place (but maybe shifting) and looming regulatory deadlines for pharmaceutical package serialization. Of course no deadline is bigger than the one set for November 2017 by the FDA for U.S. serialization – or “track and trace” reporting requirements.
“At the moment,” he tells me from his office in Middlesex, UK, “serialization for GSK means implementation at about 24 of our sites, 200 packaging lines, 600 or more products, and some 90 contract manufacturers [packaging partners] to work with.”
Remarkably – or maybe that’s why among other reasons GSK hired him for the job in 2012 – the enormity of the task never tilts Crawford off an utterly calm demeanor, and matter-of-fact delivery like he’s talking about that changeable British weather as much as the vicissitudes of serialization.
“The key to all this variability in global serialization,” he says evenly, “is the design of a robust, flexible business and process solution that is centralized at each pharmaceutical company.”
Serialization Spectrum For Packaging Partners
Crawford knows OutsourcedPharma.com focuses on the partner side of the business, and he graciously starts our discussion there.
“As well as the differences from country to country, we have a dissonance from one to another of our contract packaging manufacturers,” he says. “It seems currently all 90 have arrived at different levels of understanding, commitment and capabilities.”
At the most positive end of that spectrum, says Crawford, are the partners who have responded to the early discussions about serialization this way:
We’ve been doing this for years for Pharma; we’re compliant for China, Turkey, Argentina and South Korea, which are important markets for your products. We’re working on the next deadline you’ll need to consider, Saudi Arabia ...
“You get a warm feeling from those vendors,” says Crawford. “You know their packaging lines are equipped, and their culture is proactive.” These most advanced partners have also established standard pricing models to manage the costs for the additional work of data labeling, collecting and sharing. “They immediately start making the technical connections that allow GSK to exchange serialization product data with global regulatory bodies and others.”
Then there’s the other end of the spectrum. “Some contract manufacturing companies have hardly heard the word serialization. Those are the scary ones,” Crawford deadpans. “It’s about trying to handhold them through the learning process.” He adds: “Of course in the end, they’re providing the service and have to meet all required regulations for GSK products and markets, or we have to consider getting somebody else to do it.”
Crawford’s initial advice to service providers around the globe?
“Get fully involved now, if you haven’t already. Have people in your organization dedicated to going out in the industry to talk to contemporaries, interest groups, regulators, specialists, and your customers. Nowadays, when Big Pharma turns up on your doorstep, they need a positive response about serialization – for each product and intended international market.” Crawford again role-plays the ideal answer from a packaging provider to its Pharma customer:
We have systems in place and validated for most of your products; for the others we will be ready by this date. We have the IT and training people involved, and/or we’ve hired standard equipment vendors, solutions providers, and the integration partners proficient in serialization that we require.
We’ll talk much more about those third-party partners – the “serializers” as I’ve become fond of calling them – in part two of this article. Here we’ll continue with words of advice to other Pharma from GSK’s Crawford.
A State Of “Business As Usual”
Crawford starts with this: Big Pharma particularly must come to a realization of the effort and the length of time it takes to accomplish market-by-market serialization preparation and integration. With that understanding then comes the next realization of the need to devise a flexible, robust and centralized process.
“When I arrived at GSK, serialization was considered the second largest companywide initiative,” says Crawford. In other words, GSK had the first epiphany.
“Subsequently, a major component of GSK’s operational success will be because we moved forward to implement strategy and process through a central serialization office and strategy. We simply won’t allow for ad-hoc, site-by-site solutions.”
Crawford continues: “We haven’t yet reaped all the benefits of having a flexible, but centralized mentality, but we’ll get there. By just the pure fact of having similar versions of software, printers and track-and-trace equipment, and a flexible but robust project-managing process on each packaging site, we’ll derive great efficiencies and cost savings.”
Crawford draws a familiar analogy: “Think of this as establishing a standard batch: You validate that once, and then deploy many times. Key is getting it written down and agreed by the various quality groups and all others as early as possible. Now you can run the whole process through the cycle in the U.S., EU markets, China, Turkey, Argentina … and on and on. And, by the way, in a few years time don’t be surprised if you need to go through the process again for the same market.”
There is also a third, essential realization for Pharma; perhaps the most difficult.
“This ‘project’ is never-ending,” says Crawford, “which is certainly not what a Pharma CEO wants to hear.”
But it’s the reality, and GSK has learned to take this head on by turning the “project” into “business as usual.”
“When a country issues regulations, or new products enter new markets, key is how that’s translated into receiving and internalizing the track-and-trace requirements, working with government entities and your packaging partners, and if necessary updating every piece of software that’s involved in those serial numbers. Turning that whole exercise into an established and robust business-as-usual process – as opposed to a project-by-project mad dash for compatibility – is the essence of surmounting global serialization of your products.”
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In part 2, we’ll look more closely at the utilization of outside resources, and bring in the current director of serialization at Zenith Technologies, Carlos Machado, for further insight into the challenges of serialization.