We received a question from an Ex-USA regualtory authority requesting a list of expiration dates for reagents used in a clinial trial for a small molecule drug. Since this isn't a parameter that is normally tracked in datasets, the information would need to be pulled manually from archived notebooks, and there are over 200 batches, spanning more than a year. My understanding of the ICHM10, is that expiration dates are required for critical reagents to support a large molecule program, not all reagents, such as mobile phases, used for small molecules. Does anyone have a similar experience with a regulatory authority, and if so, is there a clever way to answer the question without spending the days it would take to pull information from the archived records?
Thank you in advance
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Sharin Roth
Director, Bioanalytical
Otsuka Pharmaceutical Development & Comm
Rockville MD
[email protected]Disclaimer: Opinions expressed are solely my own and do not express the views or opinions of my employer.
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