Chromatography Forum

Hi all!
I have a question, I can see that most of the guidance to validate analytical methods are focus to pharmaceutical products, Which guidance coul I use to validate mehtods that are not intended to quantify pharmaceutical products?

Validation is defined as "demonstrating that a method does what it purports to do". So, first you have to define how the method should perform:
- what kind of accuracy do you need?
- what kind of precision do you need?
- are you sure that you are analyzing what you think you are?
etc.
And then figure out how do demonstrate that you are meeting those goals.

The validation requirements for pharma QC assays are actually a good starting point, because those are about as rigorous as it gets.

If not the USP, what (if any) compendium are you generally expected to follow? AAOC, EPA, ASTM, other?

Watch for sources of variation - for example, if you are creating a general method for some analyite, validated it across the range of matricies that will be analyzed by the method.

Also, if you are comparing results with a previous method, you may need to test for (and even accept) bias against the other method.

Thanks all for your reply!
I think that my best opcion is the USP or ICH Q2.