A Broadway Performance Analogy for API Process Validations with Jim Mencel

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A Broadway Performance Analogy for API Process Validations with Jim Mencel

Episode Summary

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.

What We Covered

  • 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

Tweetable Quotes

Validation’s very formal. Validation really, in a stage analogy, is Opening Night. This is where the critics are all present, everybody’s breathing on you, you’re gonna be in the headlines the next day and everything needs to go… Click To TweetYour batch record really is a document that’s going to evolve. And if you look at the batch record for even the same step of a process, what that’s going to look like when you’re in the early phases of clinical development is… Click To TweetThere is a point where the process is the process. And as inefficient as it may be, it’s what you have. Click To TweetYes, your validation batches certainly count as launch stock as long as they pass all specs. Click To TweetWhen you go into validation, you’ve gotta have your suppliers identified. And quality plays a huge role in assessing your suppliers. Click To TweetWhat it all comes down to is that preparing for the validation is something that you should be thinking about as you’re making your later clinical batches, your Phase 2 batches especially. Click To TweetWhen you’re in Phase Three it’s not a place to be penny-pinching. The old saying is, ‘you drive for show, you put for dough.’ When you’re validating, you’re putting for dough. Click To Tweet

Links Mentioned

Design Space InPharmatics – LinkedIn

Design Space InPharmatics – Twitter

Edward Narke on LinkedIn

Jim Mencel on LinkedIn