Process Analytical Techniques (PAT)

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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 software is fully compliant with the 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

  • 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.

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