PAT is an enabler for designing quality into a product when quality by design (QbD) principles are applied, with opportunities to integrate real-time process analytics into pharma and biopharma manufacturing processes. Full implementation brings improvements and technologies that eliminate many risks and challenges associated with automation, monitoring, and control to focus on process understanding and science- based decision making. Real time release testing (RTR) replaces conventional end-product testing, as an element of the control strategy. This talk will cover the successful application of PAT to QbD to support RTR testing and quality systems.
1- What is PAT? How QbD and PAT work together
Interfacing manufacturing processes with analytical techniques is essential in PAT to reduce variability in the finished product. To facilitate process development according to QbD principles and to allow real-time release testing (RTR), PAT is applied to each unit operation in the manufacturing process to result in a high-quality product.
2- Types of PAT sensors, calibration, and validation requirements Based on unit operations, integrated quality assessments (IQAs) are measured by PAT tools, equipment type, multivariate statistical tools, and mathematical preprocessing. We’ll discuss the role of sensors, FTIR/NIR/Raman Spectroscopy, Imaging, Acoustic Resonance, Spatial Filter Velocimetry, calibration, and validation.
3- Regulatory benefits of PAT and RTR
PAT implementation makes it possible to control product attributes that require testing, to perform tests at relevant points in the process, and reduce cycle time. RTR is possible based on this increased process understanding, with regulatory support providing frameworks and guidelines for automation and model validation, model maintenance, and model-based decision-making.
Who should participate:
Drug manufacturing, pharmaceutical manufacturing, biomanufacturing, biologics organizations; Job function: process design, quality assurance (QA), quality control (QC), operations managers, quality management, pharmaceutical quality directors, MHA, MPH.