Episode 23 - A Broadway Performance Analogy for API Process Validations with Jim Mencel

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SUMMARY:
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Jim Mencel is Senior Drug Substance Consultant at Design Space InPharmatics. With an extensive background in CMC management, Jim has a wealth of knowledge on the topic of process validation. Process validation is an integrated and mandatory process in the pharmaceutical industry to ensure all processes are in compliance with regulatory standards. In this episode, Jim provides his thoughts on the significance and science of process validation in the pharmaceutical industry as it pertains to drug substances. He discusses the evolution of batch documentation, expounds on PAR and CPP and stresses the importance of communication.
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TAKEAWAYS:
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00:52 – Ed, Meranda and Brian welcome back Jim Mencel who shares his extensive experience with process validation
07:46 – The importance of Proven Acceptable Range (PAR) and Critical Process Parameter Program (CPP)
11:14 – The evolution of the batch documentation and the value of critical parameter studies
18:07 – Registration laws and gathering necessary stability data
20:49 – How validation material can be used for launch
24:15 – Jim speaks to the importance of writing a Protocol and having a quality supplier team
32:34 – Jim discusses timing when moving towards validation
38:02 – Jim reinforces the notion that communication is key when it comes to process validation
40:42 – Final recommendations Jim would give regarding process validation
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ABOUT CMC Live
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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.