ABSTRACT
Retrospective validation is the validation of older/legacy
products, processes, or equipments. Retrospective vali-
dation establishes documented evidence that a system
does what it is supposed to do based on a review and
analysis of historic information. It is normally conducted
on a product already being commercially distributed and
is based on accumulated production, testing, and control
data. Often these products or systems have not been
validated to contemporary standards due to their age. It
should be realized that there is a diminishing point of
return at which retrospective validation is no longer
justified. Current processes, products and equipment
are expected to meet contemporary regulatory standards
by the relevant regulatory agencies. However, all is
not lost-there is a rational approach to determine if
retrospective validation is appropriate. In these cases,
the approach needs to be evaluated and completed in
a timely manner with significant data to support the
product/process/system.
