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The following message was posted to: PharmPK
Dear Group,
in a GLP bioanalysis, QC's failed to meet acceptance criteria twice.
once due to erroneous spiking of QC's as pipette used was faulty,
(which is noticed on investigation) and second time due to instrument
failure. On a third run, batch run passed , meeting all acceptance
criteria. Will the regulators accept this kind of data? Do we need to
include any investigation report in the final report?
Thanks for the suggestions.
Regards,
Vinayak
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Dear Vinayak,
Batch is acceptable. You note down these observations/findings in lab-
records or routine observation sheets. Append an investigation report
is also a good idea but it seems over measures.
regards,
Jignesh
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The following message was posted to: PharmPK
Dear Vinayak
It is acceptable as long as give scientific justification with
investigational report.
and as you said your third run passed with acceptance criteria, so in
my veiw there will be no problem from regulatory point of veiw.
Hope it will helpfull for you
Regards
laxman kaswan
LifeSan Clinical Reserach (Centaur Pharma)
Bombay.
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Dear Vinayak,
Investigation report, further action taken both are to be recorded and
are mandatory in both of the cases. Attach a Pipette recalibration
sheet for the 1st and justification for the second. that is sufficient.
Regards,
Santosh Tata, BS (Pharm. Sci),
Bioanalytical Laboratory,
Clinsys Clinical Research Ltd,
C-46, Sector-62, NOIDA,
Uttar Pradesh, India.
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The following message was posted to: PharmPK
Dear Vinayak
If min 67% QC and individual (L,M,H) 50% is ok w.r. to total no of QC
than Batch run accepted.
Regards,
Dr.Anurag
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Dear Vinayak
Batch is acceptable. You have to give proper justification .You
have to include ur investigational report (i.e Pipette maintance
record and calibration record i.e after finding pipette faulty you
have to do maintance and recalibration) in final summary report.And
the regulators will accept data.
I think this will help you .
Kintan Patel
Sun Pharma Industries Ltd.
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