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.