I’m currently running a stability study for an IMP and have just completed the 3 month time point, with no significant change at either long term (25 C/60 %RH) or accelerated condition (40 C/75 %RH). Under EMA IMPD guidance a shelf life of 12 months can be assigned based on positive 3 month accelerated data.
My question is on how to apply ICH Q1E shelf life. The first point of the decision tree is whether there has been a significant change at accelerated within 6 months, but we haven’t yet reached 6 month testing. Can any extrapolation be performed at this time point based on this study’s data only?
While the timing of this response is well past your immediate need, a question that popped up at a Stability Statistics seminar yesterday, put me in mind of your topic. When you are not yet to the first Q1E waypoint, it is not unusual to obtain permission to enter a clinical investigation with 3 months of satisfactory data for a provisional 6 month expiry and a promise that 6 months will be obtained. If there is not a lot of data to be confident in the 6 month result, then other monthly points can be inserted to build confidence. Depending on your region, a lot of re-labeling for a changing shelf-life could be involved. As always, you are a team of Stability, Quality Assurance and Regulatory. Be sure that you assemble a solid justification, document your decision and approval and then start working with the authorities. Further comment by StabilityHub subscribers are welcome.