Process Analytical Technologies (PAT) and Quality by Design (QbD)
Module code: PHA7050-B
Module Aims
The aim is to provide specialist knowledge of the principles of Quality by Design (QbD) and Process Analytical Technology (PAT) and applications in pharmaceutical product development, manufacturing and quality assurance.
Outline Syllabus
The syllabus includes an introduction into the concepts of QbD as applied to pharmaceutical product development and manufacture and how process understanding and quality assurance have been key drivers to recent changes within the industry.
The fundamentals of vibrational spectroscopy analytical techniques and equipment and their applications to in-line process monitoring will be explored within the context of both primary and secondary pharmaceutical manufacturing.
A number of industrial case studies and recent research examples will be presented and discussed.
The practical demonstrations will include application of PAT strategies for in-line analysis of products produced by hot melt extrusion with use of experimental design for evaluation and optimization of a granulation process.
Course work will be focused on recent literature research examples, a critical oral presentation and written summary of research papers in both PAT and QbD will allow students to gain valuable knowledge in identifying critical process parameters and critical quality attributes of the products, as well understanding the key process analytical chemistry techniques used for in-line measurements.
In addition reviewing recent research will enable students to understand how design of experimental techniques and statistical manipulation of complex data can lead to a fundamental understanding of complex processes and ultimately lead to a new way of thinking within the industry.
A design of experiments workshop will also introduce industry standard software tools to enable manipulation of experimental results to gain valuable information on process parameters and ultimately lead to a deeper understanding of the process.