Unlocking the Benefits of Process Analytical Technologies ( PAT/QbD )
The Process Analytical Technologies (PAT) initiative, launched by the FDA and now referred to 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 that gap with pharmaMV, the software suite that provides leading edge multivariate analysis with real-time pharmaceutical process control capabilities.
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 compliance and conformance, both for our customers and to fully meet the needs of the industry’s regulatory authorities.
Perceptive provides full traceability, from User Requirement Specification, to Functional Design Specification, to deployed installations and ongoing programme support.
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 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. All this is now within reach for the pharmaceutical industry. 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
We believe these challenges have been met with pharmaMV.
Beyond Six Sigma – Accelerate Your PAT/QbD Programme
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 PAT/QbD applications into your existing operations 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
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
In addition, pharmaMV provides a robust platform for managing Real Time data, as well as a secure Operator Interface that satisfies 21 CFR Part 11 guidelines
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 PAT 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 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.