ABSTRACT
Validation is defined as a documented program that
provides a high degree of assurance that a specific
process, method, or system (equipment, facilities or
utilities) will consistently produce a result meeting
predetermined acceptance criteria. While this can be a
challenging endeavor at a single site, when multiple sites
and locations are involved the challenge becomes even
greater. To be successful with validation in a multi-
national organization, it takes a well-defined strategy
that is developed, executed and supported by thorough
documentation, communication and training to yield the
consistency needed between global sites. A multina-
tional company must ensure that it can repeatedly
produce the same quality products at each manufac-
turing site so that the worldwide market is supplied
with the same quality medicine regardless of the
manufacturing site.
