As our industry faces the daunting challenge of implementing systems to comply with developing Track & Trace regulations, pharmaceutical firms and pharmaceutical service providers are all over the map in their readiness to meet these new requirements. Some companies have piloted and commercialized select packaging lines outfitted with serialization to be ahead of the curve, pioneering the trail and gaining valuable lessons (although technically not a business requirement for all markets). Other firms are just now having initial dialogue on how they could ever meet the regulations now being brought forth in varying global markets.

This broad spectrum of readiness is not surprising given the fragmented and sometimes conflicting patchwork of Track & Trace regulation around the globe. At last count there were more than 35 different sets of regulations for differing markets being proposed or implemented. The inability of the U.S. and Europe to set a global standard has left developing countries to bring forth their own localized regulation with their own individual motivations and needs, exacerbating the challenge of developing a global Track & Trace standard.

As a contract packaging services provider to the pharmaceutical and biotech industry, we face some of the challenges common to the broader industry in implementing mass serialization, while some of the other challenges we face are more specific to our role within the supply chain. We are in a similar position to the common majority of companies as we look to transition from several line-level serialization programs to enterprise-level serialization across multiple sites. What follows are some of the key highlights and learnings as we have undertaken this journey.

Scope and Scale
As mentioned previously, there is no global standard for serialization. What is required, what format it is placed in, expectations for aggregation and parent/child code relationships: there are myriad options with few defined requirements across the global patchwork of regulations, both those approved and those still under governmental development. GS1 has done a tremendous job in providing the leadership to direct countries to a common platform and methodology, but there remain distinct differences amongst varying markets together with a few outliers that have not followed the GS1 standards. We support medicines destined to reach more than 100 countries globally. This effort is achieved out of multiple sites across U.S. and Europe, while supporting hundreds of clients around the world. The varying preferences and lack of standardization across these markets, not to mention the variable requirements of our hundreds of specific customer demands, creates a need for a system that is truly flexible and adaptable.

Flexibility and Adaptability
The nature of contract services is to provide a cost-efficient solution to the clients we serve. This is achieved through process efficiency, but also through efficient use of capital and assets. The contract packaging services business is based on the ability to quickly redeploy assets from one project to another, one drug to another, one packaging configuration to another. Likewise contract service companies help provide clients business agility by supporting the responsiveness for peaks in demand, changes in timelines, flexible capacity, and generally providing the business responsiveness that is required to compete in a global economy. Operationally this requires maintaining an agile workforce adept at changing direction on a moment’s notice. Similarly, assets must be able to be redeployed easily, quickly, and cost effectively to enable the seamless response required by the client to ensure their own market competitiveness and capitalize on their opportunities in the market.

Specifically for serialization, a key requirement for us is implementing a system that is consistent with our business needs, namely something that can be readily redeployed from one program to the next and one package configuration to the next. We support a wide variety of drug delivery forms across multiple sites, but require a consistent and global solution for serialization that maintains this business flexibility across all delivery forms.

Investment
As with any asset, we want to provide the best return on investment for the capital acquisition and at the same time value for the investment spend. Our business model is structured around providing best-in-class equipment and facilities so that companies looking to outsource take comfort that our infrastructure is comparable or exceeds their own. As with any business, we need to stretch our investment to its maximum potential, both in ROI as well as business flexibility and versatility.

Timeline for Implementation
As we engage clients on their serialization plans, we stress with clients to appreciate the total time to plan and implement their serialization strategies. We advise clients that the time to enable the equipment and infrastructure for contracted services is approximately seven to nine months from the time major decisions are finalized. There are several key considerations that pharma companies need to address as they look to their specific markets. The earlier that clients begin these conversations, the better off they are on the road to serialization.

The other key consideration that can affect the resource requirement and overall timeline for implementation is the impact on artwork. The vast majority of the clients we have discussed serialization with have opted for only using the barcode/human-readable approach versus supplementing with RFID, although we have experience of both paths. Meeting the requirements for the presence of both 2D barcodes and human-readable alpha/numeric codes requires a significant amount of space on their packages. It can be particularly invasive on small packages, including injectable vials and cartons. Any simple artwork change can be very resource intensive, as it takes revision to the artwork itself by the graphic artist, the proof approval process, regulatory review, specification and documentation changes, approvals from affected functional teams, and potentially changes to the packaging line configuration which may lead to validation.

The cumulative effect of changes to each component involved in serialization, particularly when aggregation to the secondary and tertiary packaging is a requirement, can add up to a substantial impact on one’s supply chain and internal/external resources. Additionally, the positioning of each child component in its container is important for 100% assurance of aggregation; this can also lead to packing process changes. Clearly, companies need to budget enough time and resources to be successful. Many companies do not fully appreciate this element of the overall impact of Track & Trace legislation.

Despite some loss in regulatory momentum in the U.S., it is clear that the pharma industry is pressing forward with Track & Trace solutions to address the rise in counterfeit and adulterated products. Individual countries, particularly in emerging markets, are implementing requirements well ahead of U.S. and EU requirements. Companies reluctant to fully engage in serialization capital projects are being forced to, at the very least, address their market-specific strategies and (for some) identify alternative means to meet the requirements for specific markets.

We advise clients that even if they are opting for a “wait and see” strategy, they need to be engaged in these conversations so they fully understand the resource and timeline requirements for what eventually will come. One thing is certain: waiting for the final 12 months of the available time to implement will create a potential “rush,” which means there will be a significant chance of collectively failing to meet the deadlines. It is a significant undertaking, but ensuring patient safety is certainly worth the cost and effort. 

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Ian Parsonage is of Global Serialization for PCI, located out of the Rockford, IL packaging site. Mr. Parsonage leads the global serialization implementation team for PCI’s 14 facilities across North America and Europe for all delivery forms. Prior to joining the serialization initiative, he held the position of Head of Information Systems for PCI’s sites in the UK. Mr. Parsonage has an extensive history in information technology including Enterprise Resource Planning (ERP) implementation, global IT integration, and business planning applications. He can be reached at ian.parsonage@pciservices.com.