The FDA defines process validation as “establishing documented evidence which provides a high degree of assurance that a specific process will consistently produce a product meeting its predetermined specifications and quality attributes.” The objective of validation, therefore, is to produce documented evidence that parts of the facility will work correctly every time, when brought into use. The goal is also to make sure that quality is built in to the system at every step; and not just a factor at the ‘output’ end of the process chain.
