Process Analytical Technology

PAT provides the ability to measure Critical Quality Attributes (CQAs) in real time, enabling continuous quality control of the process. This approach aligns with the FDA's current drug quality system, which emphasizes the importance of building quality into products by design rather than testing it in later.

In-line or on-line instrumentation is used within the PAT framework to analyze raw materials, in-process materials, and final products in real time. Multivariate and univariate instrument data is interpreted to optimize process outcomes by adjusting the CPPs, and understanding how those changes may affect the process and end product.

Multivariate analysis (MVA), also known as chemometrics, is used to analyze univariate and spectral instrumentation data to predict CQAs. Real-time quality predictions are made through experiments, which establish the relationships between CPPs and CQAs and develop true process understanding.

PAT can be employed throughout the development and manufacturing process, from laboratory and R&D operations to complex interconnected GMP processes.

Free eBook:

‘QbD & PAT for Dummies’ offers a simple and easy to follow guide on what Quality by Design (QbD) and PAT are, the regulatory framework supporting these approaches, as well as how leveraging these concepts can positively transform production processes and quality testing.

PAT delivers significant quality and commercial benefits, including:

• Reduction in waste, rework, energy consumption, and improved first-time manufacturing and production asset utilization
• Faster development and manufacturing cycle times
• Real-time quality assurance and validation with full data integrity
• Movement towards real-time product release
• Reduced inventories of raw materials, work-in-progress, and finished goods by implementing lean manufacturing processes
• Improved sustainability and more robust product supply to the public
• Increased flexibility in sourcing raw materials
• Enables Just-in-Time manufacturing, leading to a significant reduction in work-in-progress material holding
• Facilitates the transition from batch to continuous manufacturing.