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full validation versus verification of compendial methods
Posted: Tue Oct 03, 2006 10:55 pm
by srdales
How much variation to compendial method is one allowed before a full validation is required?
Stationary phase? Diameter? Mobile phase composition?
If there is a reference, please provide.
Posted: Wed Oct 04, 2006 12:27 pm
by EH
As for compendial method verification, we evaluate accuracy, intermediate precision and stability indication.
Posted: Wed Oct 04, 2006 11:47 pm
by tom jupille
There was a proposal in Pharmacepeial Forum a couple of years ago defining "default" adjustement ranges, but as far as I know, it has not yet become officially accepted by USP.
The FDA has an "internal" specification:
http://www.fda.gov/ora/science_ref/lm/v ... _04_05.pdf
but strictly speaking, this does not apply to compendial methods, so use it at your own risk.
Posted: Thu Oct 12, 2006 9:39 am
by Sunjay
The variation to a compndial method for mobile phase, columns dameters is given in British Pharmacoepia.
For the verification of a compendia method we are studying following parmaters for the formulations:
Stability of solution, specificity, filter compatibility and precision.
Regards