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Canadian validation guideline (1992)

http://www.chromforum.org/viewtopic.php?t=13889

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Canadian validation guideline (1992)

Posted: Wed Sep 22, 2010 11:51 am
by ricopalazo
Hi all,
I'm searching for an old guideline that i can't find on google.
"Acceptable Methods. Drug Directorate Guidelines, National Health and Welfare, Health Protection Branch, Health and Welfare Canada, 1992".
Does anyone has a link for this document?

Thanks all

Posted: Wed Sep 22, 2010 2:07 pm
by krickos
Hi there

Seems like Canada has embraced the ICH guideline (ICH Q2 R1)

"2.Test methods are validated, and the results of such validation studies are documented. Method transfer studies are conducted when applicable.
Note: Guidance for the validation of particular types of methods can be obtained in publications such as the ICH document entitled "ICH Q2(R1): Validation of Analytical procedures: Text and Methodology" or any standard listed in Schedule B to the Food and Drugs Act."

link to their GMP guidance as of 2009:

http://www.hc-sc.gc.ca/dhp-mps/compli-c ... ng.php#qcd

Could not find a page for withdrawn guidelines :-(
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