I’d like to ask the Stability Community what criteria they use when deciding to report a Stability Excursion (such as temperature)?
Do you follow Guidance that encourages reporting anything that exceeds 24 hours, or do you have a pre-determined a tier of thresholds based on degrees outside of range (and perhaps time outside of range). Responses here may be the starting point for a discussion at the upcoming PSDG Meeting.
I have observed both working for different companies. I personally lean toward a tiered approach as obviously the more extreme the excursion, the less time the product can tolerate without an impact. This has been difficult to define however. I am curious what the industry standard is or what other experts have put into place and defended with regulatory agencies.