Hello,

Can anybody provide any references of a general acceptance criteria(for accuracy, precision etc.) for analytical method validation that will meet FDA expectations?
Thanks in advance.

http://www.waters.com/WatersDivision/waters_website/Applications/validate/Vldt_mth.asp

The Waters website has an excellent "guide" on methods validation.

http://www.fda.gov/cder/dmpq/

The FDA website also has guidance documents regarding method validation and GMP's in general.

Melissa

Here are a few links:

http://www.fda.gov/cder/guidance/ichq2a.pdf

http://www.fda.gov/cder/guidance/cmc3.pdf

http://www.fda.gov/cder/guidance/1320fnl.pdf

http://www.fda.gov/cder/guidance/1317fnl.htm

http://www.fda.gov/cder/guidance/1318.htm

http://www.fda.gov/cder/guidance/2396dft.htm

http://www.fda.gov/cder/guidance/ameth.htm

There is also a book called "analytical method development and validation" by Ira Krull and Micheal Swartz. It gets right to the point when it comes to designing an analytical validation protocol, some of the FDA guidance docs are wordy and ambiquous. This text is also good at providing the differnces expected from FDA vs. ICH when it comes to validation. Hope this helps

DEar Anonymus;

I have read many FDA and ICH documents regarding guidelines for method validation. If you do the same you will see that very rarely there is a "hard number" for acceptance criteria, in other words, the guidelines are just that.

Go through some of the documents and try to validate the methods according with your interpretation. The FDA is always looking for documentation rather than strict limits or criteria. At the end of the day the FDA attitude seems to be like "you can do anything you want, but be ready to defend your results".

I hope this helps.

Benjamin