CMC Live - Chemistry, Manufacturing & Controls

Author: Meranda Parascandola, Ed Narke

FDA CMC regulations and guidance simplified through examination, real life experiences and risk-based advice. This podcast hopes to educate sponsors and individuals on agency related regulatory CMC matters. We will focus on the critical CMC issues and build programs that enhance drug development. CMC topics will include Regulatory Starting Materials, API and Drug Product Process, Formulation Development, Supply Chains, Analytical Controls. Advocating and interpreting CMC Strategy, directing CMC Operations and Quality Assurance oversight in conjunction with developing CMC submission content that represents the best interests of emerging biotech. NOT INTENDED TO BE PRESCRIPTIVE ADVICE BUT RATHER INTERPRETATION THAT IS RIGHT FOR YOU. Since 2007 we have provided our partners with innovative strategies and exceptional advice intended to enhance program development, product approval, and marketing presence.
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Language: en

Genres: Chemistry, Education, How To, Science

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025 - The Parenteral Drug Association & Evolution of Drug Development with Michael Carroll
Friday, 12 March, 2021

What We Covered00:55 – 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 assurance23:11 – 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.” “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.”Relevant LinksDesign Space InPharmatics – LinkedInDesign Space InPharmatics – TwitterEdward Narke on LinkedInMichael Carroll on LinkedInPDA