Unlocking the Benefits of Process Analytical Technology and Quality by Design ( PAT / QbD )
The Process Analytical Technology (
PAT ) initiative, launched by the FDA and now referred to commonly as Quality By Design ( QbD ), is rapidly gaining momentum within the pharmaceutical industry. While third-party products are available to address the issues of chemometrics and data visualisation, the industry is demanding more: fully integrated and fully compliant PAT tools that can deliver process monitoring, process control and crucially process optimisation.
Perceptive Engineering has successfully filled this technology gap with PharmaMV, the software suite that provides leading edge multivariate analysis with real-time pharmaceutical process control capabilities.
The case for PAT and QbD is clear: achieve business KPI’s by increased process throughput, increase yield, reduce rejects, lower ’cost of quality’ and exploit the opportunity to reduce energy and utility costs. Process knowledge is greatly enhanced, again driving higher quality and patient safety. Process validation expenditure and time to market can also be meaningfully improved.
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