Stability timepoints

[Lisa byrne]

#24898

Hi

For stability timepoints is there a time frame in order for testing to be completed? As if you were testing the 1 month timepoints and testing went into the 2 month time point is that valid? Can testing for 1 month timepoints be conducted along with the 2 month time point. I just haven’t seen anything in the guidelines about this.

Thanks any guidance would be great

[John O’Neill]

#24938

Generally, there is a regulatory “expectation” (not a guidance requirement, but they do issue 483’s for not meeting expectations usually conforming to industry best practices) to complete most testing within 30 days of pull point. That said, there are reasons to stretch it for things like certain microbiological / sterility tests or shrink it for tests on product parameters that change quickly once a sample is removed from its storage environment. I have heard of stacking pull points to conserve resources, but find that to be very risky without scientific justification and i’ve never seen it promoted in literature or guidance. I have seen 483’s and repeat 483’s followed by a Warning Letter for a company that failed in the long term to improve their test completion stats to a limit of 30 days. The goal should be to impliment practices and resources to achieve consistent completion within 30 days or less. Do some of our Stability colleagues have input or experiences they would like to add to this discussion?

[Walter Routh]

#24972

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.

[Author]

Posts