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Dear all
In a sample analysis run QCs are distributed throughout the run,
Midum and high QCs are placed at the end, if these two QCs are fail,
do we accept the run? even though other four QCs are passed
Regards
venkanna bayya
Bioanalytical Division
Aizant Drug Research Solution
Hyderabad
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Dear Venkanna,
Regarding your question about whether a run should be accepted if 2
QCs at the end of a run, a Mid and a High, both fail:
What do your SOPs on run acceptance say? You must follow your SOP.
If you have no SOP, then you must write one.
That said, a typical SOP on run acceptance would say that for a run
to be accepted, 2/3 of all the QC samples in a run must pass, and
for runs with 2 QCs at each of 3 concentrations, at least one QC at
each concentration must pass.
Best regards,
Tom
Thomas L. Tarnowski, Ph.D.
Bioanalytical Development
Elan Pharmaceuticals, Inc.
800 Gateway Boulevard
South San Francisco, CA 94080
thomas.tarnowski.aaa.elan.com
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As per my opinion out of 24 Qcs 18 should be pass. I do not fill that
if you two serial QC is failed means it will accepted because only
QCs are their that will give assurance about you linearity and
method. I think last QCs should be passed as it will give assurance
of the method for long term usage.
All the best
With regards
NIL
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Dear venkat
If I am not wrong you are running 2 sets of QC( lqc,mqc ,hqc) i.e
total 6 qc's. out of this 1 mqc and 1 hqc has failed is it? (other 4
passes)
If that's the case ur batch is acceptable as the guidelines clearly
states 4 out of 6 (67%) should be meeting the criteria.
Regards
Bharat Sawnani
Wockhardt
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The following message was posted to: PharmPK
Dear Bayya
Criteria fo Qc acceptance is 67% of total QC's must pass and 50% of
QC at each level. It means 4 out of 6 must pass and one Qc at each
level must pass (one LQC, one MQC, one HQC)
Regards
Vanita
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The following message was posted to: PharmPK
1) The strict interpretation is that, given six QCs, at least four of
the
six QC must pass, with at least one QC at each level.
2) If there is evidence of repeated time or process dependent failure
(sequence?) then you will need to revisit development (and
validation) to
improve stability throughout the process.
3) Some laboratories using linear sequence processing also allow-by
SOP- the
acceptance of samples bracketed by acceptable QCs. This should be
the last
approach where #2 should be the first approach.
Using number 3 will not exclude you from having to investigate and
possible
modify the method.
Ed O'Connor, Ph.D.
Laboratory Director
Matrix BioAnalytical Laboratories
25 Science Park at Yale
New Haven, CT 06511
Web: www.matrixbioanalytical.com
Email: eoconnor.at.matrixbioanalytical.com
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Dear venkanna
as per fda requirement , 67% qc at over all and 50% at individual
level should be passing. if any other criteria rather than this if
mentioned in your SOP then it needs to be followed other wise as per
fda requirement you are batch meeting acceptance criteria and there
should be no problem at all as if we are applying rejection of whole
batch only because of two consecutive samples are not meeting
acceptance criteria then same fundamental is also applicable when two
consecutive QC in middle of the run failed still we are accepting it
so its quite ok to accept the batch in conditions you are mentioning
Regards,
Gaurav ,QA,Sparc
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