MES Goes Prime Time

PharmaManufacturing.com

Error and paper process reduction are leading more pharmaceutical firms to embrace the latest shop-floor control systems

By Douglas Bartholomew, Contributing Editor

Long treated as the orphan child of enterprise software applications, manufacturing execution systems (MES) are starting to grab attention among pharmaceutical manufacturers eager to reduce errors, shorten cycle times, and automate compliance routines.

"We’ve had excellent success with MES," says Rob Ottenjohn, project manager at Patheon Pharmaceuticals, a Cincinnati-based contract manufacturer of 700 different kinds of tablets, capsules, lozenges, and liquids for more than 100 clients. "It’s helped us reduce errors, improve efficiency, and automate processes," he says.

In the last couple of years, a number of large pharmaceutical companies have adopted MES software to replace cumbersome homegrown systems or error-prone manual control procedures. The shift is yet another indicator of a broader effort to streamline and optimize production and manufacturing practices throughout the industry.

Often referred to as shop-floor control systems, MES software serves as the bridge between plant-floor operations and enterprise resource planning (ERP) systems. "We have interfaced our MES with our SAP ERP system, which also has further reduced errors at our facilities by eliminating a step of keying in information," adds Ottenjohn.

Reducing human error, in fact, was one of the prime business drivers behind Aventis Pharmaceuticals, Inc.’s (Bridgewater, N.J.) adoption of Honeywell’s POMS MES system. "We also wanted to reduce cycle time, but one of the key driving factors for the MES project was achieving a significant reduction in human errors related to documentation," says Ross Benson, former manager of manufacturing information systems at Aventis’ Kansas City plant. "We had ‘traveler packets’ that would follow an order or batch through the plant, and these would often have signatures or time stamps missing, meaning that, for each packet, someone would have to go back and track down that person."

The new MES did away with a lot of these common problems by enforcing and automating both the time stamp and signature processes. "That was our biggest savings from MES, by significantly reducing the human errors we’d been plagued by," says Benson, a Blue Springs, Mo.-based MES expert who left the company in June and plans to do his dissertation for a Ph.D. in IT on the role of MES in manufacturing.

A typical MES allows manufacturers to track orders, monitor processes, control product formulations, and gather data on errors and defects. For drug manufacturers, however, MES offers an added sweetener: the capability of automatically enforcing certain steps and routines on the plant floor. The MES ensures that procedures are followed accurately and in the proper sequence, without any data omissions, while recording each time activities are completed for compliance purposes.

Compliance a Driver

"With MES, the bottom line for the pharmaceutical industry is that it enforces compliance," says Roddy Martin, vice president of consumer package goods and life sciences industry strategies at AMR Research in Boston. "Having an MES is a means of enforcing standards to achieve compliance in the lowest cost way."

The software’s ability to track orders in progress is another benefit of MES, allowing companies to check the progress of a given customer order instantly and accurately. While this may not be an issue for most large companies dealing with large batches of product, for many contract manufacturers handling small jobs or custom orders, knowing exactly where the product is in the process can be very helpful. "Historically, the pharmaceutical industry has not been good at inventory visibility," Martin notes. "MES is one of the key enablers to improve that visibility and reduce inventory in pharmaceutical manufacturing."

Aside from enforcing compliance during production, one of the biggest payoffs for drug makers is error reduction. In an industry that, according to one estimate, is plagued by an error rate of five to 10 percent-i.e., a significant amount of medicine doesn’t meet specifications and must be reworked or treated as waste-mistakes in manufacturing are a massive problem.

The typical pharmaceutical firm spends 36 percent of its operating budget on manufacturing-more than double what it spends on R&D-and a large piece of that expense can be traced to waste due to errors in production. Botched batches, omitted signatures, improperly filled out forms, and a host of other blunders large and small each contribute to manufacturing delays, rework, and scrapped material.

While MES alone is no panacea for poor manufacturing practices, if carefully implemented with adequate buy-in and training of production operators, it can serve as a catalyst for change, forcing companies to streamline processes, automate compliance measures, and trim lengthy cycle times.

Reducing CAPA Delays

One way an MES helps manufacturers with errors is by automatically requiring employees to take immediate action when a problem occurs, thereby reducing delays in the corrective and preventive action (CAPA) remedial process. "You want the MES to launch a CAPA process so that there are no excessive lag times in that batch," Martin says. "The MES forces a response to the noncompliance problem."

Without an MES that tracks every step of a production process, he says, it often takes companies "days" to find the information they need to fix the problem. He recalls the case of one large pharmaceutical firm that held up a $4 million batch of a new product for 90 days before resolving a production problem. "With an MES, you can have role-based, event-driven information that pushes information to the person charged with doing something about it." The idea, he says, is to identify problems as they occur and resolve them before the batch is complete.