ABSTRACT
Today’s pharmaceutical manufacturing environment has
generated a large body of requirements for data from
manufacturing processes, in-line testing, off-line testing,
product testing, intermediary, stability, potency, raw
material qualification, etc. In addition, there is also data
that comes from clinical trials, i.e., API blood serum levels,
metabolite levels, etc. The common threadwith these data
is that they are generated by laboratory testing on unequi-
vocally identified samples using validated methods on
qualified instruments, analyzed by validated algorithms
on qualified computers, stored on validated computer
systems, and reported by validated reporting functions
on these and other validated computer systems that
access the stored data. In addition, some or all of these
data may be submitted to regulatory agencies as part of
the submissions required to license a new API, or to
expand the indications of an existing API. In all of the
above examples, the system that generates, analyzes,
stores and reports on this data must be in a Validated
State, if it handles GxP-related data.
