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Agnes Shanley is senior editor of BioPharm International.
Open standards based on GAMP and GS1 will soon be released and more companies are moving beyond basic compliance.
For more than a decade, the bio/pharmaceutical industry has struggled to establish a true electronic pedigree that would allow its products to be traced and verified at any point along the supply chain. The US Drug Supply Chain Security Act (DSCSA) and the European Union’s Falsified Medicines Directive set timelines and requirements for serializing product packaging, aggregating product and lot-level transaction data electronically, and sharing information with distributors and at the point of use or sale.
Even though serialization is only the first leg of the journey toward full traceability, the technical challenges and costs are significant. This is due to a “fundamental mismatch of applied integration technologies for inter-plant, plant-to-enterprise, and distribution repack exchanges,” says Charlie Gifford, technical director of the Open Serialization Communication Standard (OPEN-SCS) Working Group.
In addition, he says, distinct data elements required for serialization and traceability are interrelated. Examples include workflow rules; serial number formats; data sets (i.e., those established by regulators vs. those used by vendors vs. those for users); provisioning and serialization events; master data and associated technologies (e.g., for production, ordering, and reporting) so the data and their relationships must be agreed upon and specified for data accuracy and exchange interoperability. Understanding and agreeing on data relationships across the overall serialization process is extremely challenging, Gifford says.
Four large life-sciences companies and five solution providers established the OPEN-SCS working group in February 2015 to sort through these issues. Their goal was to stem pharmaceutical counterfeits by developing open, vendor-neutral data-exchange solutions that would simplify integration of the components and systems required for product serialization and traceability.
The group now has more than 25 active members and 100 interested supporters. OPEN-SCS achieved a number of important goals in 2017 (see Sidebar), establishing a collaborative agreement with the International Society for Pharmaceutical Engineering (ISPE) and approving the first version of the OPEN-SCS Packaging Serialization Specification (PSS 1.0).
Plans call for OPEN-SCS to release Good Automated Manufacturing Practices (GAMP)-compliant user requirement specifications (URS), functional specifications (FS), and operational and installation qualification (OQ/IQ) templates in March 2018. A core group of vendors (ACG Inspection Systems, Advanco, Antares Vision, Arvato Systems, Optel Vision, Systech, TraceLink, Tradeticity, Uhlmann, Vantage Consulting, and Wipotec-OCS) are developing validation test interfaces for one or more of the four use cases of PSS 1.0, says Gifford. Each vendor may commercialize compliant interfaces by the end of the third quarter of 2018, he says.
The group expects these efforts to reduce the cost and time required to implement serialization and traceability projects by at least 50% when applied across multiple packaging plants. “For most companies today, integration typically means custom projects,” says Evren Ozkaya, founder and CEO of Supply Chain Wizard. “OPEN-SCS will improve the standardization of exchanged data and their data structure in communications between plants, and between plant and enterprise systems, which will reduce cost.”
Reducing integration complexity and cost will be crucial to advancing traceability initiatives within smaller pharmaceutical companies, especially generic-drug manufacturers and smaller contract manufacturing organizations (CMOs), whose margins are extremely tight.
“These companies don’t typically see any direct benefits by investing in expensive systems to track their products throughout the supply chain,” says Marcel de Grutter, OPEN-SCS executive director. “Even major multinationals struggle with the fact that they are currently releasing fewer blockbusters so they are continuously restructuring to support their commercial products,” he says. As a result, implementations are delayed, as serialization competes with priorities such as ensuring a continuous supply of product. In 2017, after realizing that many smaller firms had not even begun serialization efforts, FDA extended DSCSA’s original serialization enforcement deadline by one year, to November 2018 (1).
Still, a readiness gap remains underestimated. Most large pharma companies are ready, or were a while ago, but some companies still haven’t begun formal serialization programs, while others that see themselves as ready. have only serialized part of their packaging lines, says Ozkaya (see Sidebar). “Painful days are ahead of them,” he says, because serialization efforts can lower productivity and line efficiency during early implementation stages.
The number one issue is CMO readiness, says Ozkaya. “FDA’s enforcement delay was a welcome move, but companies need to staff project teams properly, partner more closely with solution providers, and manage their internal site and external CMO compliance risks more proactively,” he says.
Observers see industry mindset as part of the problem. Until recently, most pharma company leaders viewed serialization as a compliance need, with no return on investment, says Gifford. At a time when more countries around the world are -setting serialization requirements, regulators often underestimate what it takes for any company to implement a full track-and-trace system.“Changing requirements and timelines do not help the situation,” he says.
Even though basic compliance issues remain unresolved, more companies are starting to explore ways in which their efforts and investments in serialization can be leveraged to improve overall operations. One common focus is to improve overall equipment effectiveness (OEE) in packaging, to offset efficiency decreases that can occur during early stages of serialization implementation. “Some companies have assigned dedicated leaders to work on this; others have invested in finding business use cases to extract value from serialization data and their ecosystems,” says Ozkaya.
Instead of keeping these efforts to themselves, more companies are now talking about them at industry conferences, conducting internal pilot projects and collaboration initiatives with trade partners to create long-term strategies. “A few years ago, we were trying to convince companies to look into supply chain and operational improvements in the serialized world. Today, more firms are taking the initiative and reaching out for help, which is a positive sign,” says Ozkaya. “The industry is moving in the right direction, even though its initiatives may still lack speed and momentum,” he says.
1. PharmTech Editors, “FDA Pushes DSCSA Serialization Enforcement Deadline to 2018,” pharmtech.com, July 6, 2017.
Vol. 31, No. 1
Pages: 48–49, 51
When referring to this article, please cite it as A. Shanley, " Bio/Pharma Serialization Nears a Tipping Point," BioPharm International 31 (1) 2018.