Home Forums General Discussion Stability timepoints Reply To: Stability timepoints

Walter Routh
Post count: 28

As John noted, the 30-day expectation is real, but even more important is that you have a procedure that sets your own requirements (I’d recommend not longer than 30 days). As such, if you don’t have such a requirement, you are in more risk of an observation than simply missing the 30-day expectation. The value of having your own test timing requirement is that then you’ll have an exception event (deviation) to document the action of testing one sample so late that it’s being tested alongside the following time point. That exception documentation will take care of the necessary justifications and risks involved. That said, it would really be good to avoid this situation, since data reports showing the test initiation dates (required by many agencies) would make it painfully obvious that the timeliness of your testing is suspect.