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

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 right. So, when you think about it in that context, the validation batches are very visible to regulatory authorities.” “Your 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 different from what it’s going to look like towards the end. It’s going to be much more refined.” “There is a point where the process is the process. And as inefficient as it may be, it’s what you have.” “Yes, your validation batches certainly count as launch stock as long as they pass all specs.” “When you go into validation, you’ve gotta have your suppliers identified. And quality plays a huge role in assessing your suppliers” “What 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.” “When 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.” Relevant Links Design Space InPharmatics – LinkedIn Design Space InPharmatics – Twitter Edward Narke on LinkedIn Jim Mencel on LinkedIn

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023 - A Broadway Performance Analogy for API Process Validations with Jim Mencel is an episode from CMC Live - Chemistry, Manufacturing & Controls by DSI.

This episode is 00:43:53 long.

This episode was published on Feb 26, 2021.

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