What is process validation?

Process validation is a systematic approach used to ensure that a manufacturing process consistently produces a product that meets predetermined specifications and quality attributes. It involves evaluating the process design, performance, and control measures to confirm that it is capable of consistently delivering the intended results. This validation is crucial in industries such as pharmaceuticals and medical devices to ensure safety, efficacy, and compliance with regulatory standards. The process typically includes three stages: process design, process qualification, and continued process verification.