Ask the Expert: Identity Testing on a Final Product

In this episode of the Ask the Expert video series, Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, and Siegfried Schmitt, PhD, vice president, Technical at Parexel, discuss if and when identity testing is necessary to be performed on a final product when the API is sourced from a third party.

“It's an interesting question, because you're going to get the API with a certificate of analysis, and you're going to do the identity and testing on that,” Schniepp ponders. “So I understand that they're trying to get out of redundant testing, and maybe there's a different way to approach it, but at some point in the final product testing, you're going to have to come up with what is the potency of that active ingredient in your final product, which you know you're identifying it. So, I don't know if you can say, ‘my potency test counts as my identity test, and it gives me the exact amount that's in my final product’. Bit, it's usually a fairly simple test. So, I'm not sure what the benefit you gain [from not doing the test]. You're going to spend more time justifying why you're not doing an identity test than the benefit gained from, you know, just doing it.”

Click the video above to watch Sue and Siegfried answer the following question:

“My company sources our API from a third party. Do we have to conduct identity testing on the final product before distribution?”

About the experts

Susan J. Schniepp is distinguished fellow at Regulatory Compliance Associates and a member of Pharmaceutical Technology®'s Editorial Advisory Board.

Siegfried Schmitt is vice president, Technical at Parexel and a member of Pharmaceutical Technology®'s Editorial Advisory Board.

Ask the Expert Video Series

Welcome to the Ask the Expert video series. This series is an extension of the PharmTech Group’s long-running print column in which industry experts answer common quality and regulatory questions from the industry. This new video series will expand on topic areas to include development and manufacturing concerns to help those working in the industry better understand bio/pharmaceutical requirements. Have a question you would like answered? Send it to PTProjects@mmhgroup.com, and it may appear in a future episode or print column.

We hope you enjoy the discussion!