Back to the Top
The following message was posted to: PharmPK
Dear all,
Please help me in understanding the following with respect to EMA
guideline on bioanalytical method validation.
1. How to define batch and run for EMA compliant bioanalysis?
2. The difference between batch and run: if 02 analysts process one
subject under one run, does that mean the run has two batches?:
3. How to make the validation and study sample analysis compliant with
respect to both EMA and FDA with respect to carryover and lineraity
truncation?
Thanks in advance for the suggestions...
Thank You
-arun
Back to the Top
The following message was posted to: PharmPK
Dear Arun
you can find useful slides, to clarify some issues you stated, at EBF
Simposium "Less is More"
http://bcn2011.europeanbioanalysisforum.eu/slides
My statements about your questions:
1. Batch is usually defined by an alpha-numeric batch number, for example a
batch is represented by all the samples of a study, etc.
Otherwise: run is represented by samples, calibration points and QC "run all
together", for example in a single analytical session. I mean: usually you
have many runs to analyze a single sample batch.
2. If two analysts process one subject in a single run (GLP/GMP require
usually activities of each analyst are well defined and reported, i.e. one
for extraction and another one for LC-MS/MS analysis, etc.) this is not
automatically representing two different batches, but it could be a single
aliquot of the same subject or two different aliquots of the same subject in
the same batch. Everithing has to be exactly reported.
3. For carryover you can follow the paper in the AAPS Journal
Determination of Carryover and Contamination for Mass Spectrometry-Based
Chromatographic Assays by
Nicola C. Hughes, Ernest Y.K. Wong, Juan Fan, and Navgeet Bajaj at
http://www.aapsj.org/view.asp?art=aapsj0903042
Kind regards
Stefano Porzio
Back to the Top
The following message was posted to: PharmPK
Thank you Stefano for your comments. and the link (extremely useful!!)
However my doubt was with the following
1.With reference to EMA guideline, your comments and the
presentations it was clear that Batch and run are different.
But the guideline said "run can be acceptable, although batch might
have to be rejected, as the criteria were not met"
my question now is
in a scenario of solid phase extraction, with an SPE of limited
stations (say, 24) and one subject being processed per run by the
'same analyst' in two instalments, do you call it as one run-one batch
or one run-two batches..?
Regards
-arun
|
Want to post a follow-up message on this topic?
If this link does not work with your browser send a follow-up message to PharmPK@boomer.org with "EMA Guideline-Analytical run, batch and acceptance" as the subject | Support PharmPK by using the |
Copyright 1995-2011 David W. A. Bourne (david@boomer.org)