Jason,
If you reconstitute the sample and hold frozen for 1-2 months I would advise having supporting stability data to show that the sample is stable during this time/that holding frozen for this long will not impact the results.
Otherwise, I would continue to hold the sample at 2-8C and if the testing went beyond 1 month then it is no longer representative of its originally intended time point, in which case you could footnote this in your data table or report that the sample was tested at approximately x months. If you get out as far as 3 months you may be up against the next time point or may want to pull a fresh sample, again this would no longer be representative of the originally intended time point.
Steven A. Smith
Stability Manager, Quality Control
Momenta Pharmaceuticals, Inc.
-----Original Message-----
From: Pharmaceutical Stability Discussion Group [mailto:[log in to unmask]] On Behalf Of Jason Cramer
Sent: Tuesday, May 22, 2012 11:57 AM
To: [log in to unmask]
Subject: [PSDGLIST] Stability Test Delays
Hi All,
I'd like to see what the general practices are in our circle of knowledge in times when an assay is down and there are stability time points scheduled for that assay.
For a lyo product (typically held at 2-8C), is it general practice to freeze the samples "in time" when the time point generates and hold until the assay is ready for testing, even if the assay is down for 1 or 2 months? Do you test the frozen samples 2 or 3 months after the time point generated and still list it as the original time point?
Thank you in advance for your thoughts on this matter.
Jason Cramer
QA Stability
Bayer HealthCare
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