Validation

To Validate;

verb

check or prove the validity or accuracy of

Within Good Manufacturing Practice Validation is a means of assuring the quality of a process or a product.

Companies need to demonstrate that they can make the product they have proposed to market in a consistent manner with a level of quality that is fit for purpose. They must then demonstrate their continued ability to make the same product, to the same quality standard (or higher) over the entire life-cycle of that product.

Validation is demonstrating, with documented evidence, that each step of the manufacturing process performs as expected. It requires showing that testing methods are fit for purpose.

Therefore, each critical step in the manufacturing process must be verified to perform as intended under defined conditions.