Fernando Muzzio, PhD, started in the pharmaceutical industry in 1991 as a professor at Rutgers University (Piscataway, NJ). His research focused on the engineering and mechanics of blending and mixing systems and the behavior of particles in these operations. After serving as the director of the university's pharmaceutical engineering program, Muzzio now is the director for the new NSF ERC on Structured Organic Particulate Systems and a professor of the Department of Chemical and Biochemical Engineering at Rutgers University. He is also a member of Pharmaceutical Technology's Editorial Advisory Board. Muzzio has conducted numerous presentations on blend uniformity and model-based design. For Pharmaceutical Technology's 30th anniversary, he discussed with us the significant regulatory framework that has shaped the industry, especially process analytical technology (PAT) and quality by design, and how it will change the training and skill set of manufacturing operators.
What significant changes have you seen during your tenure in the industry?
Besides FDA's CGMPs for the 21st Century document, which regulatory guidances had a major influence on manufacturing?
In many cases, manufacturers are still having the same types of problems they had before, whatever those might be. There are a lot of legacy products that were developed many years before this new framework was put in place, and those products are still manufactured by and large according to those methods and are required to meet the same compliance requirements that were in place before PAT and quality by design. PAT and quality by design are being adopted gradually; it will take a number of years before most of the products in the industry's portfolio are really developed by the PAT approach. And even then, quality problems will appear. But what will change is the methodology of solving these problems and the amount of predictive knowledge that we will accumulate either during development or during manufacturing. I think this is where the big difference is going to be. But I think also there are going to be evolving expectations in terms of quality and performance.
Going forward 10 years from now, how important will PAT and quality by design be?