monolith validation

[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?

[AA]

Why would you think that the method validation process is any different when using monolith column?

[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.

[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