• 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  

“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.” 

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