ABSTRACT
This chapter will review the utilities used in clinical
trial and production facilities, whether these facilities
are finished drug, APIs, whether the products are bio-
logical, solids, liquids, creams, ointment or sterile
products. It is important to understand the methods
needed to first determine what types of utilities are
critical to the processes and second those on the fringe
or outside the domain of qualification. This effort will
focus on the critical utilities but provide guidance on the
noncritical utilities.
