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Manufacturing execution systems: moving to the next level - June 16, 2004

Pharmaceutical Technology; 1/1/2004; Russell, Ronelle

The use of manufacturing execution systems (MESs) can provide important information to all parts of the pharma manufacturing business, helping reduce compliance costs, improve overall product quality, and ensure that the correct processes are being followed. Although MESs offer such benefits, companies must be aware of the time and costs associated with MES integration and maintenance.

Today, many companies find it difficult to keep current with the latest wave of technology upgrades and software aimed at enhancing productivity while still balancing costs with revenue. Pharmaceutical manufacturing companies are definitely no exception as they try to maintain the software systems used to monitor their plant-floor operations and assess and forecast their business. To balance these concerns, many pharmaceutical companies are using or are currently implementing manufacturing execution systems (MESs). Although these systems can provide many benefits in terms of greater automated functionality and better communication between business areas, a company should be aware of the time and costs associated with the integration and maintenance of MESs.

MESs have been used by pharmaceutical companies for several years and have provided an important interface between enterprise resource planning (ERP) systems and plant-floor control or distributed control systems (DCSs). ERP systems manage the business supply chain (i.e., demand forecasting and planning and strategic supply organizational planning) as well as the informational supply chain, which includes facility management, control, and operational and materials planning. ERP also has the job of matching the company's projected manufacturing-floor demand and its actual orders. Consequently, it must be updated weekly, biweekly, or monthly. ERP offers the broad, forward-looking view for a company, while the DCS provides the actual minute-by-minute, second-by-second real-time operation of a plant floor. The DCS is a combination of hardware and software that controls all the equipment in a plant down to the closing and opening of valves and taking readings from and setting values for actuators and sensors.

Although ERP and DCS are both integral parts of a company's automated operation, the two systems must be linked so the plant floor will know what's happening at the business level and vice versa. This is where MES fits in, taking a seat right in the middle. Before MES, this communication took place via paper documents with substantial human involvement--a process that required a great deal of time and was prone to errors. MES applications respond to this problem by automating and recording the data, thereby reducing errors and the time required to transfer information.

MES software systems send the manufacturing plan (what products to make, how many batches, and how to make them) from the ERP down to the plant floor. It then sends the data from the plant-floor operations back up to the ERP to ensure that the proper amounts of materials have been obtained and the time-to-market or customer ship deadlines are being met. The MES does this by providing recipe management and electronic batch record keeping. Therefore, MES provides important information to all parts of the pharma manufacturing business, helping reduce compliance costs, improve overall product quality, and ensure that the correct processes are being followed.

Though the potential benefits of implementing an MES are substantial, they're also not without their challenges. The time required to implement and configure an MES, the cost of initially validating the system and revalidating each time there is a change, and the combined time and cost of staying current with FDA regulations all weigh heavily on the minds of company owners when considering MES as a production automation option. Though the benefits of an MES can be great and lead a company to higher profitability, management should also assess and evaluate the difficulties they could face as a result of integrating such a system.

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