Lessons from Heparin

IT as a Solution

IT implementation is always easier said than done, but it can play an important role in safeguarding the supply chain. This year, Cephalon (Frazer, Penn.), a maker of small-molecule oncology and central nervous system therapies, began implementing both SAP for enterprise management and Sparta Systems’ Trackwise for supply chain management.

So far so good, says Roger Bakale, senior director of worldwide chemical process R&D. The company is already reaping rewards from the systems—Trackwise documentation was used to clear up a situation in which a shipper had inadvertently routed material through Canada—but it will be some time before Cephalon will be able to fully integrate and share data with suppliers, Bakale says. All manufacturers need two IT essentials, says Qumas’s Perry: a content management system, and a CAPA system for tracking deviations and preventing further occurrences. Depending on the training required, that’s a six- or seven-figure investment, he acknowledges, which many manufacturers can’t afford.

Manufacturers need to make the effort to collaborate with suppliers, and educate them if needed, says Perry. This is especially true for suppliers overseas. “Sometimes they still need computers and an IT department that understands how to keep networks up and running. Employees need basic training on operating systems, even logins and passwords—things that we take for granted,” he says. “I don’t blame manufacturers for feeling overwhelmed” by these challenges, he says.

Suppliers may not always be amenable to IT integration and increased transparency. Perry tells of a Chinese client that wanted to install a supply chain management (SCM) system, but changed its mind after realizing the system was “closed” and couldn’t be doctored. “They felt it was better to be able to trace materials some of the time rather than all of the time,” he says.

Despite the challenges, Perry says it’s important for companies to lay the foundation for IT sharing now so that, down the road, they can overlay partners’ systems. Cephalon’s Bakale says it’s not so important where a supplier is from, as what its track record is and how it manages its own quality control. Cephalon sources APIs and raw materials from across the globe, including India and China, but maintains rigorous oversight in terms of performing supplier audits, making on-site visits, and maintaining open lines of communication (including a penchant for videoconferencing). The company shies away from suppliers who subcontract, and, for materials that are considered high-risk or are used in late-stage manufacturing, prefers to source from US and European companies with proven DMFs for APIs.

Another Heparin?

Will any of these measures work? Are we doomed to experience another material contamination crisis equal to or greater than the heparin one? Probably yes. The pressure to reap profits is still much greater than any concerns manufacturers might have about crises and their consequent damage control, Perry says.

“Until manufacturers have their feet held to the fire by regulatory agencies, things are not going to change.” And, cynically, Perry says regulators won’t do this until another crisis occurs. “Not enough people have died yet” to prompt real change, he says. “I would not be surprised to see another heparin-like event occur,” says Tunnell’s Velez.