White Paper

Pharmaceutical Manufacturing: Monitoring And Maintaining A State Of Control

Tank ipad manufacturing iStock-1097343012

To ensure that a manufacturing process is in a state of control, pharmaceutical and biotech companies must create and successfully execute initiatives to meet continued process verification (CPV) and other monitoring guidelines. Life science companies implement monitoring programs so that they can adhere to regulatory guidelines, enhance process understanding, reduce process variability and improve both process consistency and predictability with the ultimate goal of improving efficiency and accelerating therapeutics to patients.

Companies must aggregate their data before they can monitor it. They need to do this in an automated and scalable fashion. After accumulating data, specialists analyze it by creating statistically sound outputs and reporting on them. To do this effectively, they should automate the creation of outputs and reports, and then scale the process. Life science companies can spend as much as 80 percent of their time aggregating, organizing and cleaning data, and only 20 percent analyzing it. The industry needs to reverse this ratio. They should spend 80 percent of their time analyzing data.

Life science companies may need to monitor tens of thousands of parameters in the manufacturing process of a single drug. To scale to that level, these parameters must be organized and accessible. To add to this already difficult task, the life science manufacturing environment has become increasingly complex with the emergence of contract manufacturing organizations (CMOs). Regulatory agencies have recently highlighted the responsibilities of both sponsor companies and manufacturing facilities when it comes to meeting process monitoring requirements.

Due to these high stakes, life science manufacturing organizations are very interested in cost-effective, global process monitoring programs like BIOVIA Discoverant—a validation-ready manufacturing analytics solution from Dassault Systèmes for data access, automated aggregation/contextualization, analysis, dashboarding and reporting.

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