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Hi all,
I would like to know your valuable opinion on one of the issues i experienced during an audit of
Bioanalytical section of a CRO .
They have a different procedure for performance of Long term plasma stability.
The case is during the process of study sample collection of a particular molecule, they store
aliquots for Long term plasma stability even without an established bioanalytical method,even though
everything is documented regarding spiking and storage.
Later on during validation they maintain the same diluent which they used for Long term stability
sample spiking and consistency is maintained in percentage spiking also.
The justification on performance of this was given by saying that procedure saves time.
We as auditors are evaluating this data and are in bit confusion that whether this procedure is
acceptable or not?
Since the data is not showing any discrepancies and all the incidents are well documented so that we
can easily reconstruct the entire process.
Have any of you people experienced similar case? I would like valuable opinion from this community
in this regard.
Thanks in Advance
Dr Jacob
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Dear Dr Jacob-
Regarding storage of plasma QC samples for long term stability assessment in advance of method
establishment or validation, as long as the preparation and storage of the samples is clearly
documented, matches the preparation and storage described in the method that is validated, and
matches regulatory expectations (e.g., documentation practices consistent with GLPs/GCPs, the entire
process is described by a CRO SOP and or protocol, qualified freezers, etc), then it should be
acceptable.
Since the storage dates will initially look inconsistent with the Validation Study and related
dates, they would very likely attract attention by inspectors and auditors, so it would be
particularly important to be sure that the process is especially compliant and clearly and
completely documented.
Perhaps others have more direct experience or comments.
-Tom
Thomas L. Tarnowski, Ph.D.
Bioanalytical and Compliance Consultant
ttarnowski1.aaa.aol.com
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Dear Dr Jacob-
After hitting the "send" button in my reply regarding storage of plasma QC samples for long term
stability assessment in advance of method establishment or validation, I realized I left off
something important: The time clock for validated stability of the samples can only start when the
stored samples are thawed and analyzed by the validated method for the first time. If the method is
not yet developed, you'll need to wait until you have the method to determine the drug in the
samples for T0. If you have a method, but it's not yet validated, you'll need to validate it
exactly the way you ran it for the T0 analyses, or else provide a convincing documented
justification that any changes to the method have no impact on storage stability.
Because of this, I question how much time a CRO might actually save by preparation and storage of
Long-Term Stability QCs in advance..
-Tom
Thomas L. Tarnowski, Ph.D.
Bioanalytical and Compliance Consultant
ttarnowski1.-at-.aol.com
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