PAT, Quality by Design and Scientific Risk Based Approaches - Fundamental Change in the Pharmaceutical Industry
Systematic methods and tools for managing the complexity
Process Analytical Technology - PAT (T4-6)
Keywords: pharmaceutical, PAT, risk, quality-by-design
The pharmaceutical industry has some of the poorest OEE (overall equipment effectiveness) figures in the manufacturing sector. Add to this the steadily declining amounts of drugs being successfully submitted (despite increased spending) and an increase in the amount of recalls of unsafe product from the marketplace and all seems less than ideal for the pharmaceutical sector.
However, the pharmaceutical industry, backed by the regulators, is driving towards a fundamental shift in attitude to the way it thinks about processing.
The key force driving this change is the desire to understand more about current processes and those still under development. Increased process understanding will help optimise current processes and improve the design of new processes with the result of reduced variability, improved quality and reduced cost.
Processes in development will target the scientific-risk based understanding of their fundamentals - leading to scientific rich, documentation light submissions to the authorities.
This presentation will seek to highlight some of these fundamental changes (being driven by the PAT, 21st century GMP and quality by design initiatives) and detail what this means for the many billions of dollars that is spent on pharmaceutical processes and their development each year.
Presented Wednesday 19, 11:00 to 11:20, in session Process Analytical Technology - PAT (T4-6).
