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monolith validation
Posted: Wed Feb 11, 2009 5:48 pm
by blaise5669
Has anyone tried to validate a monolithic column for the USP or FDA? Could you please tell me what difficulties and trials you had to go through?
Posted: Sat Feb 14, 2009 3:12 am
by AA
Why would you think that the method validation process is any different when using monolith column?
Posted: Wed Feb 18, 2009 5:34 pm
by blaise5669
I don't really think that the procedure itself is that much different, but most of the approved methods I've reviewed don't include monoliths, and I was just wondering if anyone had had any trouble.
Posted: Wed Feb 18, 2009 8:01 pm
by danko
I would suggest the following method:
Just do all the tests you would do with any other column and the results will show whether or not the monolith presents a special case.
And it might help remembering, that validation is not a test of a hypothesis but documentation of what you know (i.e. you’ve done the relevant tests – at least informally - prior to documenting the knowledge you posses).
Best Regards