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Jennifer Markarian is manufacturing editor of Pharmaceutical Technology.
Pharmaceutical Technology spoke with Gloria Gadea-Lopez, associate director of Shire, and Martin Dittmer, PharmaSuite product manager at Rockwell Automation, about how manufacturing execution systems (MES) can improve productivity and the current challenges faced by companies implementing MES systems.
Manufacturing execution systems (MES) are computer programs that collect and manage manufacturing data. In pharmaceutical manufacturing, MES are used to manage recipes and collect data for electronic batch records and, ideally, are part of an overall manufacturing operations management system. More companies are looking at the collection of meaningful process data in electronic form as a result of FDA’s guidance for continuous process validation and verification, says Gloria Gadea-Lopez, PhD, associate director of Shire. Pharmaceutical Technology spoke with Gadea-Lopez and with Martin Dittmer, PharmaSuite product manager at Rockwell Automation, about how MES can improve productivity and the current challenges faced by companies implementing MES systems.
BenefitsPharmTech: What benefits are driving the use of MES in pharmaceutical manufacturing?
Gadea-Lopez (Shire): MES is a key system that has tremendous potential because it provides a global view of the manufacturing operation, raw materials usage, and equipment status, to name a few. In addition to continuous process validation and verification, more emphasis is being placed on key metrics (e.g., right first time, process discrepancies); MES is key in this area because it can enable ‘review by exception,’ which has the benefits of saving time and resources.
Dittmer (Rockwell): Life-science companies are facing a changing healthcare landscape, generic competition, heightened regulatory scrutiny, expansion into emerging markets, and persistent economic changes (both expansion and slowdown). These challenges increase pressure across the industry to better manage risk, improve asset utilization, and drive cost cutting and speed. By having equipment capable of collecting a wide range of performance and operating data, companies can gain a competitive advantage. With optimized data collection capabilities, end users have readily accessible information that is visible across the enterprise. This information enables individuals at all levels to understand asset operation with a holistic view of the plant, helping personnel make informed decisions, reduce downtime, and improve plant productivity.
Currently, many life-science companies are faced with islands of automation, a complex application landscape, aging equipment, and/or manufacturing processes designed for validation, but not efficiency. Any modification to the manufacturing process requires change control, long lead time for quality checks, and batch-record reviews before a product is approved for shipment--a timely, often inefficient process. As equipment ages, it is inevitable that concerns about part sourcing, service, potential productivity losses from old technology, and increased risks of downtime become stronger. Best-in-class companies, however, are quickly realizing the need to leverage manufacturing technology as an asset and invest in automation systems that allow them to stay ahead of consumer demand, improve traceability, and reduce cycle times.
Challenges PharmTech: What limitations in existing MES technology need to be addressed?
Gadea-Lopez (Shire): An important benefit of a successful MES implementation is that key information generated during the manufacturing process becomes available in electronic form. Although some level of reporting is available today with MES, the task of troubleshooting and analysis in an all-encompassing manner is limited. Ideally, process information from batch records, raw-material details, and results of in-process and product-testing results should be aggregated and routinely analyzed. Successful process troubleshooting and thorough data analysis rely on the availability of data collected from GMP-compliant sources that has been transformed in meaningful ways to yield trending and visualization. Currently, organizations must customize MES to extract data and aggregate it with data from other sources to produce the desired analysis. System interfaces between MES and data-analytics tools still remain to be demonstrated.
PharmTech: What challenges do companies face in improving data management in manufacturing?
Gadea-Lopez: The most significant challenge is integration of data from multiple sources while maintaining an accurate representation of the complex manufacturing processes. Biologics manufacturing involves a series of linked operations with a complex lot genealogy. The correct representation of the inputs and outputs from each unit operation is needed to analyze data in a meaningful way. One area to be addressed is data acquisition from vendors/suppliers, which can be a challenge because raw-material data is typically provided as paper certificates of analysis, which require manual transcription into an electronic system. Enabling portals where raw-material suppliers can input their information is potentially one solution, but it comes with some challenges (e.g., security). Additionally, more companies are adopting single-use systems. The successful implementation of disposables in MES is still an emerging area that needs to be further explored. The algorithms used to represent ‘equipment clean status,’ for example, are no longer applicable in their traditional form. Also, raw materials and single-use equipment are intertwined, making traceability more complex. Finally, finite scheduling (either as part of MES or in stand-alone systems) would require definition of entirely new steps, previously irrelevant in conventional stainless-steel plants.
About the Author
Jennifer Markarian is the manufacturing editor for Pharmaceutical Technology.