ABSTRACT
In the overall history of pharmaceutical manufacturing,
the need to validate is a relatively new addition to what is
required by worldwide regulatory agencies. While the
concept is only about 30 years old, the impact on our
industry has been profound. The need to validate all
aspects of the manufacturing process is a common
requirement worldwide. As a manufacturer, it can seem
complicated when trying to gain global approval for a
product. A review of the historical background of U.S.
and European regulatory requirements will not reduce
what is required to gain approval, but may allow for a
better understanding of the issues. This understanding
may also allow for the development of approaches that
will ultimately reduce the overall workload.
