Home › Forums › General Discussion › Repeat challenge for in-use stability testing of sterile drug products in EMA › Reply To: Repeat challenge for in-use stability testing of sterile drug products in EMA

John O’Neill
Moderator
May 8, 2024 at 11:30 am
Post count: 75
#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