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Jennifer Markarian is manufacturing editor of Pharmaceutical Technology.
MES has already rewarded early adopters by reducing errors; next-generation technology will enable broader data analysis.
Manufacturing execution systems (MES) automate production processes and, although often perceived as high-cost investments, can offer significant return on investment by improving efficiency and reducing errors. In addition, new web-based approaches to implementation promise to reduce cost and improve interoperability between different vendors’ systems.
Pharmaceutical Technology interviewed three of the industry experts who presented at CBI's 10th annual conference, MES 2015, (Aug 12–13), about the benefits of implementing MES and their vision for the future of MES.
Benefits realized today
Over the past 10–15 years, pharmaceutical and biopharmaceutical companies that have implemented MES have seen ongoing, quantifiable benefits from improved efficiency. One of the most significant benefits is the reduction of human error by, for example, automating data collection, entry, and reporting through use of electronic batch records (EBR) and electronic production records (EPR).
"People make mistakes-often simple mistakes that are not caught by other people. Our attention wanders, we lose focus, and we get distracted and forget important steps," notes Dennis Brandl, immediate-past chairman of the Manufacturing Enterprise Solutions Association (MESA) Americas board, president of BR&L Consulting, and keynote speaker at the MES conference. "By reducing the need for human input, providing auto-checking workflows, and letting the computer double-check work, productivity in the pharma industry has been continually improving. Companies that have implemented MES and other workflow automation systems have seen year-to-year productivity increases that don’t go away."
In addition to automating mundane, manual data-collection tasks and getting more product through an existing manufacturing environment without increasing headcount, MES increase the efficiency of the product-release process, adds Keith Bowen, general manager of LZ Lifescience. Bowen gave a presentation at the MES conference on developing a business case for MES. "Following an automatic executing sequence for making a product, with the quality team working in parallel with the production team, leads to at least a 25% increase in productivity," explains Bowen.
A high level of automation is not required to achieve benefits, he says. "In a small pharma solid-dose plant that I visited recently, the per-year measurable benefit was half a million dollars, with an ROI of less than one year," he reports. A key to developing a business case is targeting measurable, objective savings and mapping these to MES product modules for specific products. It is important to use actual manufacturing activity data and to purchase only what is needed, Bowen says, because large MES modules may contain functionalities that aren’t required for a particular company's process.
Web-based “app” systems
In addition to perceptions of high cost, another barrier to MES adoption in pharma has been lack of cross-vendor compatibility, says Brandl, "Workflows developed in one system cannot easily interact with workflows in other systems; data collected in one system is not easily shared with other systems. This means you have to pick one vendor and stick with them, even if they are only adequate, or even inadequate, in some areas."
Brandl suggests that MES suppliers embrace the “app” model that uses independent internet application programs to share data from multiple vendors in one human-machine interface environment. A virtualized system on a smart phone or tablet would create a lower entry cost and enable more companies to use MES more fully. "Even with measurable economic advantages, companies are still reluctant to spend hundreds of thousands of dollars to implement MES," says Brandl. "With a lower entry cost...benefits can be applied to all areas of production, not just those with the biggest problems."
Web-based MES products are already available, Bowen says. "Web-based MES products reduce the cost of MES solutions by hundreds of thousands of dollars and even more for large sites, and that is just on the hardware costs. The software sequences can be configured more quickly using a library of modules and operations which provide the building blocks for new-product master-batch records, resulting in a faster time to benefit from an MES solution."
A long-term vision for MES in the pharmaceutical industry is to have "streamlined, efficient, out-of-the-box business process library templates for manufacturing facilities (of each type)," says Bowen. MES will allow the facility of the future to combine the best workflow practices of the past 20 years with new, more efficient, corporately controlled business processes, he notes.
Requirements for next-generation MES
Analyst and advisory firm Axendia presented findings from a survey of the MES life-science community at the conference. The objective of the survey was to identify current issues and benefits, as well as requirements for next-generation MES.
The survey found that many in industry view MES primarily as a tool to solve the problem of eliminating human error and ensuring that records are complete (i.e., regulatory compliance), notes Daniel R. Matlis, president of Axendia. "FDA wants industry to focus on quality rather than compliance, but two-thirds of brand owners surveyed identified ‘improved regulatory compliance’ as the main benefit when implementing MES, while only 44% see improving product quality as the top benefit. We would hope to see that product quality is the driver, and that compliance is the baseline and a direct side effect." Software vendors who answered the survey had yet another perspective, with 60% selecting a reduction in data entry errors and reducing manufacturing cycle time as the most important benefits of MES.
The survey went on to show an even bigger disconnect between vendors and brand-owners regarding the top future requirements of MES. Most vendors (67%) chose "Internet of Things" as a top requirement, but brand-owners selected "global visibility," "predictive maintenance," and "manufacturing optimization."
"This dichotomy is a concern because vendors may be building software to support an internet of things, but this may not be a fit for what industry says it needs," notes Matlis. "The ability of MES to support global visibility is key because industry is globalizing. Most MES today are designed for one plant, resulting in the need to aggregate data for multiple sites. To optimize capacity and improve product quality, however, decision makers need to be able to compare parameters at multiple sites to identify critical to quality attributes and prepare accurate forecasting."
In addition to global visibility, next-generation MES should provide visibility across the entire supply chain. "Much of the metrics data that FDA is looking for in the new quality metrics initiative could come from MES. Visibility throughout the supply network is important, however, because the brand owner may need to report data from outsourced processes, not just the in-house manufacturing pieces," explains Matlis.
Improved predictive maintenance is also part of optimizing manufacturing processes. "Software should provide tools that enable industry to become proactive and ultimately predictive of product quality, which ties in to operations, maintenance, and training," says Matlis.
These capabilities either don't currently exist in MES or are not user friendly, concludes Matlis. "It is important for vendors to support the needs of brand-owners and for both to look forward to ensure that the systems being implemented address the future needs of industry rather than merely fixing issues of the past."