Hi Jeroen,

To me, the ICH Q14 guideline lines up the different steps one needs to go through in order to develop good methods. As such, there is nothing really new in my opinion, and it should also not surprise people either. However, it is nice to have it all in one place. I especially appreciate the part on Analytical Procedure Control Strategy. Working in a business where we buy a lot of critical materials and supplies from vendors, we seem to forget sometimes how vital it is that we can control and release our medicines for the patients. If we are not in control of the critical parts of our methods, such as through buying proprietary method kits, how can we then assure the safety of the patients? ICH Q14 helps me in this discussion.

But I am sure others have other good reasons or purposes of the guideline, and I am looking forward to learn what others think!