Riding With The Drug "Serializers" Of Pharma

By Louis Garguilo, Chief Editor, Outsourced Pharma

In our article with Terry Crawford, Serialization Technical Manager at GSK, we mentioned the assistance Pharma receives from external serialization software and hardware companies, partners, consultants, and integrators. Like the benevolent gunslingers of Wild West movies, they ride into town, clean up the situation, enforce the laws, and then move on.

Or something like that.

In our reality, these serialization partners are hired to help devise corporate strategies, implement software and hardware, and ensure individual packaging lines at both internal and packaging partners comply with new track-and-trace regulations set forth by the FDA, CFDA, EMA, and all other agencies.

While in the movies the initial decision to bring in these gunslingers can be difficult, there’s no moral equivalence in Pharma’s decision to do so: Few drug makers – or  packaging service providers – will achieve timely serialization compliance without outside assistance.

I’ve started calling this assistance “the serializers.” Crawford was one at Zenith Technologies, before GSK hired him. Another is Carlos Machado, the new director of serialization at Zenith; we’ll saddle up with him to get a street-level view of the serialization battles.

4 Levels Of Serialization

Machado rides into town from the direction of project management. “I believe everything in life is centered around project management, whether it’s making scrambled eggs the way you want them, or implementing key business objectives,” he says.

What nobody wants is scrambled implementation. To ensure we don’t get that, Machado says companies like his have to become subject matter experts who understand the various requirements for compliance in each national or regional drug market. Projects work out for the best when the serializers are involved with clients from the beginning of strategy and project discussions. He assigns four levels to serialization projects with his customers.

Level 1

Physical packaging lines with devices such as printers, cameras, scanners, lighting, all integrated within complicated packaging machines like cartoners, case packers and palletizers. These devices serve as the integral parts in the inspection process required for track & trace (T&T) purposes.

Level 2

Line Management Systems (LMS) containing software that manages all the Level 1 devices, and is responsible for inspection controls, communication and integrations with the machine and management of T&T operations, and for the serial number management during production batches. The LMS manages the process of serializing at the unit level through aggregation to the bundle, case, and pallet, forming the critical child-parent relationship, while also collecting data.

Level 3

Site application servers (SAS) responsible for the communication between Level 2 and 4. SAS are modular and connected to other applications. Some of the SAS functionality can be seen through its ability to handle material master-data, process orders, event posting, and how it interfaces with enterprise resource planning (ERP) systems, special application programs (SAP), and manufacturing execution systems (MES).

Level 4

Level 4 is the actual communication for carrying out the tasks and operations throughout the corporate level. In this environment, Pharma can interface with corporate software, or directly with the packaging lines through the Level 3 server. This family of software has various functionalities: ERP systems transfer information to the lines; T&T systems transfer to the packaging lines the serial numbers needed to identify the physical objects, and collect the status of the serial numbers at the end of the production; MES can perform batch-related functions.

“Taken together,” says a proud Machado, “this is project-management delivery for serialization.”

A Looming Sunrise … Or Sunset

We spoke about global markets in our first article with GSK’s Crawford. But the biggest market is the U.S., and Machado walks us through what he thinks happens as we near the November 2017 deadline for U.S. serialization compliance.

“The first telling sign may be in Q2 of 2017,” he says. “I don’t think there are enough resources at supporting companies or within the Pharma companies themselves to collectively handle the workload that will still be out there.”

He explains: “From the perspective of an integration company or provider of track-and-trace solutions, if for example, you currently have four Pharma clients each with about 400 packaging lines globally, 200 of which you’ve completed over the last two years … you’d now have to complete a new line every few days to be fully ready for mid-November. Given that each project can take months, depending on complexity, I’m curious to see how that plays out.”

Machado envisions more than a few Pharma companies visiting with their regulatory contacts to say: “We’ve been able to get 65 percent of our lines completed. Is there an extension possible? Can we use what we’ve accomplished as evidence we are pushing forward?” Surely some of those talks are already occurring.

Will the FDA by accommodating, and consider the full burden and extent of the new regulations on Pharma and its service providers? After all, we’re talking about an aggregate on the scale of many thousands of employees to work on tens of thousands of packaging lines around the world. The degree of compatibility – or incompatibility – and the answers from the FDA, “will soon tell us a lot more about what actually lies ahead,” says Machado.

He thinks it’s a “real possibility” the FDA could offer some sort of extension, such as a percentage of lines that need to be finished in each subsequent quarter, up to an extended deadline to reach full compliance. “Frankly, a lot of people are hoping for this extended project life cycle.”

If the agency takes a harder line? “Well, let’s say now it’s January 2018, and packaging lines are not ready,” Machado replies. “Drug products may not be allowed off the shelf. Companies would lose millions of dollars daily. That’s a real scenario.”

This could also result in serious patient impacts, and a number of other negative ramifications, all of which we’ll have to leave for other articles. But let’s turn Machado to thoughts on the readiness and efforts he’s seeing at contract packaging companies specifically.

“Many of these companies have been proactive, and are doing a great job at meeting deadlines around the world,” he says. “I know personally of a major packaging provider that has their own, dedicated internal teams, all the software and hardware, and took this challenge upon themselves from early on.

“But if there is a packaging company that a Pharma customer finds is not willing or able to keep up, product will be diverted to an internal facility, or they’re going to look for another packager.”

Even with all the potentialities, uncertainties, and extensive work left to be done, Machado remains sanguine. He stays firmly focused on the collective industry’s project management efforts for compliance. And one thing is certain: We are nowhere near the end of our movie. The serializers won’t be leaving town anytime soon.