Serialization: Why manufacturers and packagers must prepare now

By Pharmaceutical & Medical Packaging News staff in Serialization on November 04, 2015

It is time for pharmaceutical companies and their supply-chain partnersincluding their contract manufacturing and packaging partnersto establish all expectations for serialization projects and begin. 

By Graham Clark, TraceLink

In response to increasing drug integrity concerns, more than 40 countries have introduced track-and-trace laws to help regulate product as it passes through the supply chain. By 2019, more than 75% of the world’s prescription medications will be protected by legislation. While no two countries have passed the exact same requirements, they all rely on one core component: serialization. Serializing product—assigning unique, traceable numbers to individual saleable units—is the cornerstone of all the regulations.

Serialization is a complex process that will have a ripple effect throughout operations at both pharmaceutical companies and their contract manufacturing and packaging partners. The process of implementing serialization in your company—whether you represent a pharma company or an outsourced partner—goes far beyond creating a number and affixing it to the side of a package. Serialization introduces a paradigm shift for the industry. As a manufacturer, your company has been focused on producing identical units to an exacting standard. With serialization, the focus evolves to producing that same product, identifying each item with unique data, communicating that data to supply chain partners, and then—depending on your supply-chain role—potentially accounting for that data for several years to come. 

When and how do you begin to prepare? This article will help you with the “how” by discussing considerations and first steps for both pharmaceutical companies that are manufacturing their own product and for external partners that are packaging on their customers’ behalf. And in reviewing that, the “when” will become readily apparent: as you map out the dates by which you’ll be required to deliver serialized product and then work backwards, taking all necessary steps into consideration, you will realize that the time to start is now.  

Two Major Projects, Many Cascading Challenges

In order to produce product in a serialized world, two major projects must be addressed: lines upgrades and trade partner integrations.  Let’s consider what’s involved with each, what additional questions they raise, and where to get started.  

Line Upgrades

Serializing product requires upgraded packaging lines, and those upgrades involve their own set of challenges and decisions, including:

Equipment. You will need to determine new equipment needs. Will your current printers, for instance, be able to produce the required 2-D bar codes? And are your vision systems up to the challenge? Line system vendors are predicting that as the entire industry prepares for serialization, order fulfillment times will balloon to several times their usual length, so factor in lead time.  

Specifications. You will want to understand your company’s or customer’s exact requirements. How many lines, for instance, will be expected to support aggregation? That alone will impact the set up and significantly increase the cost.  

Commercial responsibility. If your pharma company manages all production internally, line upgrades will clearly be funded by your brand. But if you outsource some production or represent a contract partner, the question of financial arrangements is a big one. Upgrades may cost between $250,000 and $500,000 per line. Who should pay?  

Many contract partners will be looking for pharmaceutical company support—especially for dedicated lines—but pharma companies will have their own opinions about whether to contribute at all or how to split financial responsibility with both the contract firms and their other pharma customers.  There is no established commercial model for this, so each partnership will require negotiations.   

Downtime. You can’t upgrade lines without incurring downtime. How long will each upgrade take? Adjust production schedules to ensure that you have enough stock of whatever products depend on those lines to get you through the process.   

Artwork. While design changes aren’t strictly part of line upgrades, they are one more consideration during this process. Many pharmaceutical companies are finding that label changes are required in order to make room for the 2-D bar codes and any human-readable components. When that’s the case, time must be built-in for both the redesign work and the FDA approval of the revised layout.  

Trade Partner Communication 

Physically serializing product is just one half of the challenge. The other half—trade partner communications—is arguably the more-daunting endeavor.  

Connections. The U.S. regulations mandate that supply-chain companies perform some combination of generating, tracking, exchanging, and storing serialized information. How will your pharma company send the serial numbers you’ve created to the contract partners that are packaging your product?  And as a CMO, how will you communicate back serialization events—reserved, commissioned, decommissioned, destroyed, and more—that occur at your facilities and may need to be tracked in order to ensure the integrity of the serialization data?  

You will need to electronically integrate with each pharma or CMO partner. Traditional technology supports this via individual, custom point-to-point connections. But there is a high cost and level of effort associated—particularly since evolving regulations necessitate frequent changes—and each one takes approximately 9 months to establish. If you’re targeting the November 2017 DSCSA serialization deadline, you really only have 18 months left, because most pharma companies are going to want a 6-month buffer to allow for unanticipated complications and to ensure their product is ready in time. Is 18 months enough time to tackle each of these connections, plus attend to all your other preparations?  

Variable demands. If you provide contracted manufacturing and packaging services, you likely serve numerous pharmaceutical customers. Because each of them has a unique set of internal systems, each of them will have unique and complex integration demands around mapping, event choreography, transmission protocols, validation, and more. Collecting, understanding, and implementing these demands from clients who have no intention of following any sort of standard will add untold time and effort to your process.  

Multiple Partners Multiply the Complexity 

In many regards, working with multiple partners will complicate serialization for both pharmaceutical companies and their contract partners. CMOs, you are at risk for being inundated by pharma company requests all at the same time, and potentially at the last minute. Pharma companies, you are balancing internal and external production plans and can’t afford to prioritize one behind the other, or you won’t have serialized product in time.  

There are two key steps you can take to expedite your progress and simplify the overall process: 

Start conversations now. If you haven’t already had a detailed requirements conversation with each pharma or contract partner, get the ball rolling. Use a checklist for pharma companies or contract partners to help guide the discussions.  

Simplify your approach. Serialization in today’s global supply network is inherently a network data exchange problem, which means relying on traditional technology for partner communications will be a painful—and potentially untenable—option. Look toward new technologies for a shared platform or network data exchange solution that would reduce individual connections and mitigate unique partner demands.  

Graham Clark manages CMO/CPO Partnerships at TraceLink, a company focused on helping pharmaceutical manufacturers, distributors, and dispensers deliver safe prescription medicines to patients everywhere with the largest track-and-trace network in the life sciences industry. Clark collaborates with the global CMO community to ensure that they are ready to support their customers’ serialization requirements. He also works with major pharmaceutical brands to implement CMO serialization programs.

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