Repeat challenge for in-use stability testing of sterile drug products in EMA

[Wei Wang]

#25502

https://www.ema.europa.eu/en/documents/scientific-guideline/note-guidance-use-stability-testing-veterinary-medicinal-products-excluding-immunological-veterinary-medicinal-products_en.pdf

This guidance from EMA states about Repeat Challenge study. Does anyone have practical insights on how best to do the repeat challenge study ?

I have a Liquid in Vial drug product with 65 mL fill volume and would like to register 56 days in-use period (this is more than 28 days) and therefore repeat challenge is required. But I can’t find information on how best to support this repeat challenge study.

[John O’Neill]

#25530

Hi,

Looks like the requirement is about continuing preservative effectiveness testing throughout the extended period (56 days) with perhaps weekly test intervals (will require sufficient in-use exposure sample quantity). Curious to see what others think. If this reply is read in time, there is an In-Use Discussion webinar hosted by AAPS at 3 pm eastern on Thursday, May 9. That would be a great forum in which to raise this question. https://www.linkedin.com/feed/update/urn:li:activity:7187205237856743425/
John O’Neill
StabilityHub Editor

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