May 2008


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Cindy Bach <[log in to unmask]>
Reply To:
Pharmaceutical Stability Discussion Group <[log in to unmask]>
Thu, 29 May 2008 13:27:06 -0500
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Hi Everyone,
We polled this subject quickly at the end of the PSDG in May and I
reviewed the PSDG archives for items related to this subject, but I
still need some clarification for my management about company policies
on sample analysis time.  What are some typical turnaround times from
the date samples are removed from the chamber to the date the samples
are analyzed (assigned assay date).  Please note your definition of
assay date and if your response is from an R&D or QC perspective.  With
your replies, please indicate if this information is contained within an
SOP and if you monitor the number tested within the target window.
My Information:
I am from R&D, and our unit SOP for analysis of routine stability
samples has a sliding scale for target analysis times based upon the age
of the sample when it is pulled from the chamber.  The date assayed is
defined in our SOP as the date the sample was prepared (i.e. removed
from the original container for dilution, colorization, etc.)
- 1 week for samples <= 4 weeks old 
- 3 weeks for samples  > 4 weeks old, but <= 13 weeks old
- 4 weeks for samples > 13 weeks old
Within that same SOP, we set a two week target for review of the
analyst's work by the supervisor.  We run a weekly report to determine
the number of samples that were assayed and reviewed by their respective
target due dates.

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