[Histonet] glp lab

Madary, Joseph MadaryJ <@t> MedImmune.com
Fri Oct 8 12:19:54 CDT 2010

We run one here and trust me when I tell you the best thing to do is to
actually go to one and see for yourself what the deal is.  There is a
lot to it.  I suggest you take some classes as well in GxP.  Imagine
this, an FDA inspector comes in to the lab and picks out one HE slide.
That slide has several SOP's attached to it and those SOP need to be in
NAACLS format, the folks who did all the work on the HE from necropsy
through labeling need to have a cv on file showing relevant training and
experience that states they are trained to do whatever their part of the
HE they did, and that they read the SOP used on the process. Which hurts
people like Joe Nocito who still can't read(hi Joe).  If they cut the
section there needs to be proof they are trained to section.  Then oh
yeah all of the reagents used to perform necropsy, trimming, embedding,
microtomy, staining, coverlsipping, labeling, archiving(another GLP
situation) need to be dated and labeled with lot numbers, batch numbers.
There needs to be logsheets on everything from temps of the water bath
temps and water checks, when the slides were stained,  when the tissue
was run on the processor and all of the maintenance as well as proper
use of maintenance SOP's. Did you use a scale or pipette?  Where are the
calibration logs?  When you calibrated the Ph meter did you use outdated
ph buffers, I hope not loser cuz you just failed that part of the
inspection. Take any CAP inspection and multiply it 5 fold on the level
of detail on everything. Running a GLP lab is doable and a great way to
run a lab, but you will need to increase your staff in the lab just to
cover the documentation.  Good Luck.  This is as far as we can go here
due to the nature of our business. 



Medimmune Histology Mgr, 

OMW, Area 4, Lab 2438





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