“There is a great deal of interest in expanding connections between pharma companies and their contract manufacturers,” Schroeder adds. “But the contract manufacturers look at it as a way to get a competitive advantage by having a QMS in place.”
Still another stumbling block preventing the industry from fully embracing more IT systems for collaborative purposes is a widespread concern among pharma companies over exposing their proprietary information to others. “The pharma industry still has a real fear of exposing their quality systems to suppliers,” says KR Karu, pharmaceutical industry solution director at Sparta Systems, a provider of quality management systems.
“When it comes to the business systems, there is a back-and-forth of data sharing between systems,” he says. He cites just-in-time ordering data utilizing shared inventory information, shared purchasing information and other supply-chain data that is routinely provided by pharma companies to their outsourcers, and vice-versa. Not so, however, with product quality data, which often is kept within the manufacturer’s systems.
By contrast, Karu points out, “In the high-tech world, the electronics firms’ partners are in their systems as if they work there.” Although most pharma companies adopted quality management systems years ago for use inside their own firms, few were willing to share that data with their contract suppliers. The result has been that many drug companies now find themselves handling quality issues the old-fashioned way. “Now that the industry is moving to more of a real supplier base, pharma companies are dealing with quality problems through phone calls, faxes and emails,” he says. “There are quality issues falling between the cracks, I am sure, as a result.”
The gains to be had by sharing quality data, however, far outweigh any concerns over data security, asserts Sparta’s Karu. “For example, when you have a manufacturing deviation, you are not sure what the cause is, and having all hands on deck throughout the supply chain is important,” he says. “You need visibility and transparency across the organization. If you have a supplier that fails, you need to know right away, so you can find another supplier somewhere in the world who can provide this service.”
Standardization of data is another key area for collaboration between the pharma firm and the contract provider. “One of the top life sciences companies is working with us to take standard procedures and standardized data so that everyone is doing things the same way,” explains Ken Rapp, managing director and senior vice president at Accelrys, a provider of lab execution and management systems. “As a result, we are now getting real transfer of process data between systems.”
This kind of connectivity between systems at different partner companies has been extremely difficult up until now, Rapp asserts. “It’s been nearly impossible to get the job done in the past, but I think there is change afoot,” he says. “Today we have tremendous pull between the supply side and the partner side to get this done.”
As an example, Rapp cites a pharmaceutical client that depends on Accelrys to keep close tabs on what’s happening at its suppliers’ labs. “We have a customer with three contract suppliers that they monitor closely. They run a dashboard every day to see what’s going on with the manufacturing process at their three partners,” he says.
“It’s become a critical need for our customers to know what’s going on,” Rapp adds. “They want systems that include process informatics, and they want them faster, easier to deploy, and with shorter times to get to the benefit. We need to broaden the number of companies that can take advantage of these systems.”
Published in the February 2013 issue of Pharmaceutical Manufacturing magazine
ABOUT THE AUTHOR
Doug Bartholomew is a journalist specializing in manufacturing, technology and finance. His articles have appeared in New York Magazine and Los Angeles Times Magazine, and he is a former senior technology editor for IndustryWeek and senior writer at InformationWeek.