"You can't manage a product without information, and compliance is impossible without information," he says. The challenge for Ferring was that all of its batch information was generated via paper-based methodologies, embedded in standard operating QC procedures that extended the time from batch manufacture to release to 44 days or more. In 2010, Ferring began its journey by implementing at its premier facility in Saint-Prex an eBR/MES solution based on FactoryTalk® PharmaSuiteTM from Rockwell Automation.
eBR and Real-Time Transparency
According to Repiton, paper-based systems are full of “hitches,” and no matter how well-organized a paper-based system might be, it could never deliver the real-time process transparency Ferring needs to manage its supply chain effectively. "An eBR solution is the GPS of manufacturing operations,” he says. “It guides the user to the desired destination, finds the shortest trip, alerts one to dangers and provides feedback in real time."
Repiton explains that Ferring understood that eBR was the key to process transparency. If one has process transparency, one can understand process trends in the same time frame and know immediately if there has been an excursion that might affect quality. With technology providing process data from Rockwell Automation that is characterized by the batch recipe — the "destination" in Repiton's GPS analogy — any deviation becomes known virtually instantaneously via the application's dashboard.
"When you work with paper, you have to wait for someone to review the paper," he notes. Armed with real-time process information, qualified personnel can conduct batch quality review during manufacturing rather than after and manage by exception: "If nothing's wrong, then it is OK to press the button," he says.
For Ferring, implementing FactoryTalk PharmaSuite was both a process quality and quality assurance process improvement program. The company now is able to track time in process, and that includes time spent in QA/QC review. According to Repiton, time in process has been cut in half — a dramatic improvement and one of the primary goals of the whole endeavor.
Since the eBR/MES program began in 2010, the number of batches processed by the company has jumped from 7,000 to 11,000. That's a 56% leap in just five years with the same amount of staff, “representing a real return on investment,” according to Repiton.
With FactoryTalk implemented and pervasive process data available to key operations, Repiton says Ferring created a solid basis to integrate the system with its IT infrastructure, including laboratory information management and enterprise systems, to provide an MES that truly supports the organization's compliance and competitive agility goals.
The company plans to roll out the total solution across its international operations and to its new facilities in India and the United States. Characterizing it as an operational excellence project, Repiton concludes that Ferring is much better equipped to cope with the complexities associated with biopharmaceutical manufacturing and to proactively comply with demanding regulators around the world.
Learn more about the Rockwell Automation FactoryTalk Suite.
