ABSTRACT
In an ideal world, validation would begin with and 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 developmental pathway. There are also circumstances for which 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. Appropriate application of the principles discussed may be applied for either a change-control procedure or for revalidation, based on specific needs.
