What is Process Validation?

Process validation is documented evidence providing a high degree of assurance that a specific process will consistently produce a product meeting its predetermined specifications and quality attributes. It is a critical component of quality assurance, especially in industries like pharmaceuticals, medical devices, and food processing. Validation involves a series of steps to ensure the process is well-defined, controlled, and capable of consistently delivering the desired outcome. Common approaches include prospective, concurrent, and retrospective validation, each suited for different stages of a product's lifecycle or process maturity. Key aspects include process design, process qualification, and continued process verification.