A year ago, Nutramax Laboratories Inc. was struggling to meet the Food and Drug Administration’s Good Manufacturing Practices (GMP) regulations using manual systems to develop raw material forecasts, manage material inventory and execute batch records. Now, the company is benefiting from a Manufacturing Execution System (MES) project that was completed in four months.

“This system gives us real-time vision into all types of information that’s available to all levels, from management to the plant floor,” says Miomir Adzic, manufacturing manager at Nutramax Manufacturing Inc., an Edgewood, Maryland, unit of Nutramax Laboratories. “In the past, we spent a lot of time reconciling raw material inventories and finished goods inventories.”

As a maker of joint supplements and other non-pharmaceuticals, Nutramax Labs doesn’t have to comply with the FDA’s Good Manufacturing Practices policies for pharmaceuticals. But the company uses GMP as a benchmark for manufacturing what are commonly called nutraceuticals, which are food supplements with scientifically supported benefits.

Automating the process provides a number of benefits. One is that managers now have far more insight into the manufacturing and ordering processes than when they had to pore over paper trails. “Our MES provides real-time information that tells us instantly how much raw material we need to execute our forecast,” Adzic says.

That type of insight is something that more and more pharmaceutical companies are trying to get. Drugmakers are catching the wave of using technology to increase productivity, and are increasing their efficiency by using MES and other tools. Technical advances have made it far simpler for companies to tie operations together, gaining the benefits of enterprise-wide communications.

“When data flows seamlessly, companies can make decisions in real time and they don’t need to worry about duplicating data,” says Glenn Restivo, life sciences marketing manager at Rockwell Automation Inc., in Milwaukee.

Among the key drivers behind the slow shift to MES are increasing competition from companies that can quickly re-engineer a new drug and get a competitive product to market in a few months. Growth of generic drugs is also making price more of an issue, spurring drug makers to cut their production costs.

Though pharmaceutical companies are used to working in a regulated environment, they’re increasingly finding themselves in a litigious environment as well. Some are responding by using MES to track products—monitoring production lots through manufacturing and out to the store shelves.

“Traceability goes all the way to the Wal-Marts and CVSes, which are starting to feel the pain of recalls. They’re putting pressure on pharmaceutical companies to use RFID (radio frequency identification) tags, so that when there’s an incident report, the supplier can do an immediate search and say, ‘This is the batch number that needs to be removed,’ ” notes Bharat Nair, high tech industry director for Brooks Software, a division of Brooks Automation Inc., in Chelmsford, Mass.

There’s also a widespread feeling that the era of blockbuster drugs such as Viagra is fading, so companies won’t be able to set up factories that make only one product for months at a time.

“As blockbuster drugs go away, companies need to set up for smaller runs of successful drugs, using existing plants but switching lines instead of running the same product all the time,” says Bart Reitter, life sciences manager for GE Fanuc Automation, in Charlottesville, Va. Instead of reading instructions on paper, operators can tap into an MES system that sends recipes needed for setup to plant floor equipment while also communicating with front office systems that control ordering and inventory management. Automating these changeovers is an easy way to reduce manual operations.

Error avoidance

“When plants are doing hundreds of products, making one of them every three months, the chance of errors rises. MES lets them avoid errors that arise from manual systems,” says Rick Sterrett, chief operating officer at Honeywell POMS, of Phoenix.

This type of automation can significantly improve efficiency. “We’re doing more with statistical process control, triggering alarms when the manufacturing process starts to deviate, so operators can react before the product goes bad,” says Yves Dufort, director, strategic programs, for Wonderware, of Lake Forest, Calif.

Monitoring statistical process control data can reduce the likelihood that unacceptable products can be produced in large batches before problems are spotted. While MES provides more insight into the broad production process, it is only a monitoring system. “MES can’t solve problems, but it gives you early warnings of problems in your facility or in your supply chain,” says Brooks Software’s Nair.

Though observers cite many benefits for ...