I'm trying to qualify my HPLC system and I would like to know if there is any bibliographic reference about the limits and tolerance of the parameters that I'm qualifying: accuracy of pump flow; accuracy, linearity and carry-over of injector;accuracy, linearity and limit of quantification of detector; oven temperture... etc.

Sincerely,

Ana Guillén

Now you've gone and done it. Opened a can of worms. IMHO, the manufactureres specs for the instrument are a good place to start. They usually give a limit that is usually realtively easily achievable. The limits used will depend on a few things, the assay chosen for the tests, age of the instruments, etc. One thing you do not want to do is to make the limits so tight that they are hard to achieve. You could spend days trying to get a system validated if this is the case. Linearity and limit of detection are compound related, so again, it depends on what method you are using to do the qualification. I am in the process of writing SOP's right now for our facility. It is not an easy process.

At our company our HPLC suppliers have done the qualification the first time, and afterwards we wrote a similar protocol for the qualification for ourself.
Very easy because you don't have to search for limits and choosing the test conditions.