ABSTRACT
Before a new product can be released for commercial
distribution, it must undergo successful validation.
Unlike a PQ, for a piece of equipment, Product Validation
examines the process under which a product is made, for
robustness and reproducibility. Product Validation is the
documented evidence that a process will, with a high
degree of scientific assurance, consistently produce
product that meets its predetermined specifications and
critical quality attributes, as required by the cGMP
regulations for finished pharmaceuticals, 21 CFR 211.100
and 211.110 (1) and the EC Guide to GMP (2). The
validation phase for a new product should be viewed as
a part of the entire life cycle of the product; as a journey,
not a destination.
