ABSTRACT
The origins of validation in the global healthcare industry
can be traced to terminal sterilization process failures in
the early 1970s. Individuals in the United States point to
the LVP sterilization problems of Abbott and Baxter,
while those in the U.K. cite the Davenport incident (1).
Each incident was a result of a non-obvious fault coupled
with the inherent limitations of the end-product sterility
test. As a consequence of these events, non-sterile
materials were released to the market, deaths occurred,
and regulatory investigations were launched. The
outcome of this was the introduction by the regulators
of the concept of “Validation”:
