Improving Process Validation for Dry Granulation, Solid Dosage Form Unit Operations

Effective process validation contributes significantly to assuring drug quality. The FDA defines process validation “as the collection and evaluation of data, from the process design stage through commercial production, which establishes scientific evidence that a process is capable of consistently delivering quality product”. Process validation establishes the elasticity and restrictions within the manufacturing process controls to deliver upon the specified attributes of the dosage form while preventing undesirable out-of-specification results.