Validation report for multiple staining

Roberts, Daniel Daniel.Roberts at covance.com
Thu Jun 26 09:34:24 EDT 2008


The big ticket item here in the states is the FDA's 21st Code of Federal
Regulations (CFR), part 11. This entails computer/system validation to
ensure the integrity of electronic data. I'm not sure if the Canadian
Guidelines have something similar for electronic data capture, but that
should be the only hurdle. As far as a Method Validation goes...if you run
your protocol - no matter how many colors - and perform a comparison to
microscopy or other gold standard technique for your endpoint, as long as
the governing scientific body of your lab signs off on it, you should be
good to go. I had IT QC, Management, and Authors/testers sign off on my
documents, with QA giving the final approval. 
 
I've validated 2 flows, a BD Calibur, and a BD Canto, and most of the
validation work is spend on the electronic data / system security portions.
Your QA department should have some sort of format for dealing with GLP
automation - unless the flow is their first piece of equipment that will
generate data. Just so you know, unless you are going to submit the data for
an IND or NDA, I do not believe that you need to go the FDA GLP 21 CFR part
11 route. Here's a website though if it will help:

http://www.21cfrpart11.com/ <http://www.21cfrpart11.com/>  
 
Also, if you share details of the method you're validating, I'm sure that
some of the experts on this distribution list will have some pointers on
which antibodies / gating logic is more appropriate. 
 
Good Luck!
Dan
_________________________
Technical Resource Specialist
Genetic Toxicology Department
Covance Laboratories, Vienna, VA
703-245-2200 x5136 (Office)
x5589 (Lab)
 
  _____  

From: Cythéris - Stéphanie BEQ [mailto:sbeq at cytheris.com] 
Sent: Tuesday, June 24, 2008 12:36 PM
To: cyto-inbox
Subject: Validation report for multiple staining
 
Dear flowers,
 
I have just join a private company (I was previously working in the
academic) and one of my topics is to install flow cytometry (not a problem
for research use) by Quality Assurance (that is the problem) and I'm not
familiar with QA. I have already found the Canadian Guideline for flow
cytometry (2001) and the H42-A2 from NCCLS on the web and the daily/monthly
QC of the instrument itself should not represent a big difficulty, but the
validation of staining, antibodies panel, compensation, multicolor analysis,
gating, reproducibility, what kind of calibrator should I choose.....remains
unclear for me.
Is anybody having a two (or more of course!) colors staining validation
report (or validation plan)? It could be really helpful for me to adapt it
and develop it for an 8 colors panel.
Does more recent guidelines exist (FDA or CDC or else?) ?
Thank you for your help.
 
Best regards,
 
Stéphanie Beq
 
 
 
******************************************** 
BEQ Stephanie
Immunological Studies Manager
 
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CYTHERIS S.A.
Technopolis, 
175 rue Jean-Jacques Rousseau 
92130 ISSY-LES-MOULINEAUX, France 
sbeq at cytheris.com <mailto:bassouline at cytheris.com> 
www.cytheris.com
Tél: 33(0)1 5888 3819  
fax 33(0)1 4644 4446
 
 
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