The BioPhorum Operations Group (BPOG) established a digital plant maturity model (DPMM) for biopharmaceutical manufacturing to define stages of factory evolution “from simple paper-based plants through to the fully automated and integrated ‘adaptive plant’ of the future.” The model gives organizations a common tool for industry comparison and measurement of progress. It also provides a platform to facilitate collaboration within the life sciences industry and its technology providers.
Initiating Good Manufacturing Practices (GMP) production operations, whether as part of facility start-up, product changeover, or following a shutdown, requires complex coordination of both logical and physical process controls. Inefficient configuration and qualification practices for automation and information management systems can lead to both start-up delays and productivity losses.
Technology has continued to advance and provide ways to assist pharmaceutical & biopharmaceutical manufacturers with production readiness. Improper set up and qualification of automation and information management production applications cause start-up and product changeover delays, as well as slow performance during production runs.
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