Home Forums General Discussion Criteria Used for Reporting a Stability Study Excursion? Reply To: Criteria Used for Reporting a Stability Study Excursion?

adam.keisker
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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.