ABSTRACT
In an ideal world, validation would begin with parallel
product research and development activities. Validation
for lyophilized products occurs more often during scale-
up to manufacturing. Under growing regulatory pressure
and the realization of the greater benefits, however,
validation activities are being undertaken while the
product is along the development pathway. There are
also circumstances where validation is required for
existing commercial products, either because of changes
requiring additional study or to meet current regulatory
standards. This presentation will approach validation as
an integral part of developing a new product. Appro-
priate application of the principles discussed may be
applied for either a change control procedure or for
revalidation, based upon specific needs.