Process Analytical Technology (PAT) and Quality by Design (QdB) of Chemicals
Course Feature
Class Description
The use of appropriate analytical equipments and sensors in line and at line offers to several sectors of chemical industry (and in particular to pharmaceutical industry) a more efficient and eco-compatible ways to develop new processes and improve the existing ones. Process analytical technology (PAT) is a tool for controlling industrial processes when combined with implementations on quality arising from a Quality by Design (QdB) approach (“Quality cannot be tested into products; quality should be built in by design”). PAT is defined by USFDA and EMEA as “a system for designing, analyzing, and controlling manufacturing through timely measurements (i.e., during processing) of critical quality and performance attributes of raw and in-process materials and processes with the goal of ensuring final product quality.” The approach is founded on process understanding and process optimization to facilitate innovation and risk-based regulatory decisions as important tool for Quality by Design. The course provides an overview to the tools and principles of PAT and QbD with representative applications.
The course covers the following sections:
- PAT and QdB vision and framework;
- process analyzers in PAT applications;
- data analysis (MDA and DfE);
- micro- and milli-reactors and micro separation technologies;
- PAT in Manufacturing Risk Management;
- PAT in Automation Control Systems (SPC);
- Critical steps in quality by design and design space;
- PAT and QdB in bioprocesses and in Process Validation;
- Regulatory Approach.
