Biomedical Engineering Reference
In-Depth Information
accident reports, complaints, QA audits, and problems
discovered at critical control points identifi ed in each
system within the establishment's total operation.
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Another source of topics for continuing cGMP training is the
set of FDA warning letters, accessible from
www.fda.gov
.
This is an extensive compilation of GXP deviations of all
sorts that can be mined for topics. There are two problems
that emerge when using these resources.
First, the warning letters refer to companies other than
that of the training audience, which tends to blunt the
signifi cance of non-compliance, no matter how serious. For
striking examples, FDA inspected the Peanut Corporation of
America (PCA) in early January 2009 and found “one
environmental swab collected on 1 October 2009 from the
fi nished product cooler fl oor was found positive for
Salmonella
. The swab location was within three feet of
pallets of fi nished product.” Moreover:
. . . mold was observed growing on the ceiling and walls
in the fi rm's cooler used for fi nished product storage. In
addition, water stains were observed running down
from the cooling unit fans in the cooler. On 1 October
2009, pallets of fi nished product were stored directly
beneath this unit.
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The training audience can easily say, “Yes, these are terrible
conditions, but they took place in Georgia.”
The second problem is that many times the warning letters
do not provide the level of detail needed to develop compelling
cGMP training. This is the case even when the warning letter
is augmented by newspaper accounts. Again this tends to
blunt the signifi cance of non-compliance. It is very clear that
something was seriously amiss in the PCA environmental
