A semiquantitative term referring to the maximum possible exposure, dose, or risk, that can conceivably occur, whether or not this exposure, dose, or risk actually occurs in a specific population
1) A set of conditions encompassing upper and lower processing limits and circumstances, including those within standard operation procedures that pose the greatest chance of process or product failure when compared to ideal conditions Such conditions do not necessarily induce product or process failure 2) The highest or lowest boundary value of a given control parameter actually established in a validation qualification exercise