The JOURNAL

The JOURNAL

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Pharma Companies Go Paperless with Electronic Recordkeeping

Learn how an MES upgrade helped Wyeth pharmaceuticals to slash cycle times and labor costs by reducing paper usage.

The pharmaceutical industry is a complex business, and this multifaceted nature developed from a series of imperatives. These include the need to provide patients with the best products; for regulatory authorities to inspect production records; and for the pharmaceutical industry to rigorously manage its production processes. As a result, the pharmaceutical industry is one of the business world's largest users of paper.

Forms, batch records, logs and manuals have been at the heart of every production process. However, with advances in technology and envious glances at the successes of other manufacturing industries such as automotive, a momentum toward paperless production is now underway.

The business benefits of minimizing paper records are clear. With an electronic system, pharmaceutical companies can speed the manufacturing process, improve asset utilization, reduce the cost of goods and improve quality. Despite the natural hesitation of the industry and regulators to tinker with a proven, albeit cumbersome, paper-based system of production management, the underlying benefits of automation have become too promising to ignore.

One company with both the foresight and opportunity to take the step toward paperless production is Wyeth's pharmaceutical plant in Newbridge, Ireland. Wyeth's Newbridge operation was set to build two new facilities to produce oral contraceptive and menopausal drugs. The company decided to put a paperless production process in place using a Manufacturing Execution System (MES) from Rockwell Automation.

Why Wyeth Moved to MES

"Our analysis showed that we could achieve a number of business benefits," explains Marian Brennan, MES project manager at Wyeth Newbridge. "Using a complex paper-based process to manage production can be a slow process, and we found that we could improve our supply of capacity constrained products by simply speeding up throughput."

The MES allows Wyeth far more access to real-time information that's used to constantly monitor and improve the production process, helping improve overall cost efficiencies. The company has reduced the level of inventory stock it needs to hold, improve equipment utilization, and reduce manufacturing losses. This has led to shortened cycle times and reduced labor costs.

Finally, Wyeth believes that MES would help improve quality by improving compliance and first-time quality. The analysis was supported by tests of an MES at one of Wyeth's other manufacturing facilities in Puerto Rico. "A similar result at the new facilities would deliver a major business benefit," notes Marian.

How the MES Works

MES was integrated with Wyeth's Enterprise Resource Planning (ERP) system and integrates with Data Historian Software (DHS) and plant automation. Delivering real-time data entry and updates, the automated, electronic system helps eliminate the need for paper-based tracking and information systems.

Wyeth views the MES as having four key components:

  1. The Weigh/Dispense module helps ensure that the right material is released in the right amount to the right batch. This module uses step enforcement so that each element of the process is carried out in exactly the correct order. It also tracks all material used and provides an audit trail throughout the process.
  2. The Electronic Batch Record (EBR) module is used to author, create and use the recipes for each product. It makes sure that only the approved recipe version can be used, delivers step enforcement through batch record, provides a tracking and audit trail for the production process and triggers alarms when processes are incorrectly completed.
  3. Data Historian software captures raw data such as temperature and pressure as well as alarms and triggers in real-time, outside of the EBR. This allows trends and data analysis to be carried out on the production processes.
  4. Integration is essential to the success of the project, making sure the system delivers across the production process. It allows MES to talk to the ERP and Laboratory Information Management System (LIMS) plus the plant floor automated equipment and the mobile MES used to monitor equipment use.

"The system effectively automates the entire process," Marian says. "Batch ID download and selection, recipe creation and start, alarm monitoring, automation reads and writes and batch synchronizations are all taken care of."

The initial results at the Irish Wyeth facility show that paper has been reduced from about 100,000 pages to 8,000 pages a year. This has been achieved by eliminating paper batch records, equipment records, equipment logbooks, cleaning records, intermediate process and material labels and logbook controlling documentation.

What's Next

The paper remaining in the process is typically related to the quality assurance operations. Marian says the next step is to move the organization to a Review by Exception process in which all exceptions to the standard validated process that occur during the batch production are presented in a consolidated, electronic list to the reviewer for batch release.

Although Wyeth has made great strides in its drive toward paperless production, Marian sees this last step to Review by Exception as one of the last major hurdles — the final challenge in delivering true paperless production in the pharmaceutical industry.

For more information about MESs for pharmaceutical companies, visit www.rockwellautomation.com/go/lstj.