Process Analytical Technology and Quality by Design
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, increased yield, reduced rejects, lower ’cost of quality’ and 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.
Quality By Design
Perceptive Engineering put in place a robust Quality Management System based on industry recognised ISPE GAMP guidelines. Throughout the development, testing, deployment and lifecycle of our software, we adopt best practice principles. These ensure the highest standards of regulatory cGMP and GAMP compliance, both for our customers and to fully meet the needs of the industry’s regulatory authorities.Compliance
Our products are fully compliant with the very latest regulatory expectations, including US 21 CFR Part 11. Personnel training and careful management of our projects, products and processes ensures continuous compliance.The Challenges and Opportunities of PAT/QbD
Over the past 30 years, Advanced Process Control ( APC ) has delivered significant commercial and operational benefits across a wide spectrum of process industries: the opportunity to reduce waste, optimise production times, achieve real-time quality improvements through the application of closed loop control to Critical to Quality parameters. Perceptive Engineering have a wealth of experience in Multivariate Statistical Process Modelling and Model Predictive Control and this expertise is now within reach in the pharmaceutical industry for PAT implementations. The particular challenges presented by tight regulation do require specific tools to ensure security and traceability:- enhanced real time data cleansing
- traceable control actions
- precise control within a non-linear “Control Space”
- integrating process monitoring with control, to provide additional assurance that the integrity of the control system is maintained
Beyond Six Sigma, Accelerate Your Process Analytical Technology and QbD Programmes
Perceptive Engineering’s pharmaMV is already in use by pharmaceutical leaders, delivering operational, commercial and competitive advantages to World Class companies.pharmaMV will help you develop and integrate Real-Time Process Analytical Technology and Quality by Design applications into your existing operation by:
- Providing a Real Time environment for integration of Spectral data, batch data and discrete lab measurements
- Providing Real Time multivariate monitoring facilities
- Providing facilities to develop and deploy in Real Time chemometric calibration models
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Enabling comprehensive Advanced Process Control facilities, such as
- Batch Endpoint Prediction
- Batch Model Predictive Control
- Latent Variable Control
- Dynamic Multivariate Monitoring for Batch and Continuous processes
pharmaMV has been developed by Advanced Process Control ( APC ) specialists in close co-operation with the world’s leading pharmaceutical manufacturers. It provides a fully-featured engineering development environment that includes all the practical analytical techniques and tools that pharmaceutical Process Analytical Technology teams are demanding. To help harness its power, the software is designed to be intuitive, structured to help guide the user from preliminary data mining, through multivariate analysis, then on to predictive monitoring, control and process optimisation.
Many pharmaceutical manufacturers require additional support as they begin exploiting the benefits of PAT / QbD. Perceptive Engineering offer an introductory course and consultancy package designed to help you unlock this potential.
On our main web site www.perceptiveapc.com you will be able to find further details of Perceptive’s pharmaMV suite, application case studies and our contact details. If you are ready to accelerate your PAT programme, we are ready to help.