Michael Carrol is Senior Consultant of Microbiology and Aseptic Manufacturing at Design Space InPharmatics. He is an accredited Microbiologist with over 35 years of product development, quality control and GMP manufacturing experience in the pharmaceutical, biotechnology and medical device industries. In this episode, Ed, Meranda, Brian and Mike discuss the Parenteral Drug Association, the role of regulatory approvals and other stories from Mike’s illustrious career. They talk about the ever-evolving nature of CMC and the pressures of working in drug development and manufacturing.
“The PDA was kind of the bridge. It’s the Parenteral Drug Association – its focus is sterile injectable product. But it’s into all kinds of different things.”
“The biggest things that are most frequently used in my case are the media fill, as Brian mentioned, and environmental monitoring.”
“When you cite regulations from Europe, it used to be you would pull the British because they were gonna be the standard. If you could pass Brit, you could worry about anybody else at all; you were fine.”
“It’s an entire system that you’re trying to get where every little thing that fits into the process has been qualified and can be depended on. From the raw materials coming in the door to the viles, to the stoppers, to the machinery, the environment, the filters, the air quality and differentials – all of that stuff fitting together.”
“With drug development, you’re not having a life depend on you. You’re having tens of thousands of lives depend on you.”
Design Space InPharmatics – LinkedIn