The Parenteral Drug Association & Evolution of Drug Development with Michael Carroll
Quality Management Systems Explained!
March 5, 2021
Episode Summary
Michael Carroll 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.
What We Covered
- 00:55 – Ed, Meranda and Brian welcome today’s guest, Mike Carroll, who speaks to his background in microbiology and product development
- 04:28 – Mike talks about his involvement in the Parenteral Drug Association (PDA)
- 07:51 – Lessons Mike has learned throughout his career and expounds on the relevance of PDA technical reports
- 15:03 – The evolution of regulatory approvals in the pharmaceutical industry
- 17:34 – Mike describes the influence of the PDA today, given the pandemic
- 20:18 – Mike explains a typical day working in microbiology and quality control and assurance
- 23:11 – The pressure of working in pharmaceutical drug development and final comments from Mike
Tweetable Quotes
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. Click To Tweet The biggest things that are most frequently used in my case are the media fill, as Brian mentioned, and environmental monitoring. Click To Tweet 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. Click To Tweet 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… Click To Tweet With drug development, you’re not having a life depend on you. You’re having tens of thousands of lives depend on you. Click To TweetLinks Mentioned
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