ABSTRACT
Validation has perhaps been the most frequently
discussed subject in the global healthcare industry over
the last 30 years. It has been applied in so many varied
areas that its scope is seemingly endless. Validation, an
exercise that was initially associated solely with steriliza-
tion processes, is now discussed in relation to automated
systems, analytical methods, dosage form preparation,
cleaning procedures, active ingredient manufacture via
either classical synthesis or biotechnology, andmanyother
areas. In order to better understand how it is practiced, it is
useful to understand its evolution. This chapter will
review the history of validation from its onset, with the
intent of clarifying howmany of today’s current practices
originated.
