March 2013


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"Freel, Dan" <[log in to unmask]>
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Pharmaceutical Stability Discussion Group <[log in to unmask]>
Fri, 8 Mar 2013 22:38:08 +0000
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I would like to know how others handle these issues, I've broken them down into 2 parts:

*         How many data points (or minimum time, e.g. 12 months) do you require before you trend individual studies.   We are wondering this as at less than 12 months for some tests, the 95% confidence interval can be pretty wide.

*         When you encounter a trend that shows the 95% confidence interval crosses before your expiry,  but you are still well within spec., what type of action do you take?     Do you add an interim time point to monitor (and show diligence) or wait until the next time point (which might be 12 months away)?   I should add that this test method can have some variability, so this isn't unprecedented for us to see and we don't expect the product to go out of spec. looking at historical data.

Any input would be beneficial.    I'll summarize the responses and publish.


Dan Freel
LIMS Administrator, Quality Control Laboratory Support

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