Bioequivalence and Bioavailability Forum

Dear Hale,

❝ -What criteria should our SOP involve?

Have each person document what he/she is doing. Don't have runs with part of the samples extracted by one person, and part by the second person (one run, one person).

❝ -Do authorities accept this approach?

Yes.

❝ -Do you know if any CRO conduct their projects with this way?

In my experience that's common practice.

❝ -Do we have to perform full validation for each project assistant,

No.

❝ if no, which parts of the validation should be done?

Most labs will have at least one run for precision and accuracy from each of the analysts. The rest of the validation can be either done by a single person, or split between the two as you like. If your method is really analyst-sensitive, then you should probably go back to method development and try to find a more robust method.

Regards
Ohlbe