Validation

Published February 2000

A process used in industries that manufacture drugs, biologicals and medical devices that establishes documented evidence to provide a high degree of assurance that a specific facility and its supporting utilities will consistently meet predetermined specifications and quality attributes. These attributes and specifications encompass both regulatory and company requirements. Validation is regulated by the FDA, including CBER (Center for Biologic Evaluation and Research) and CDRH (Center for Devices and Radiological Health) as well as the Department of Agriculture.