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.
“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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