Process Validation: A 17-Year Retrospective of Solid-Dosage Forms

Abstract

The author takes the reader through the various stages, phases, and steps in the product and process development sequence of solid-dosage form design (tablet and capsule) using process validation principles and practices as a guide. The challenge for the pharmaceutical industry as it approaches the next millennium is to streamline and/or simplify validation requirements without sacrificing product quality and process flexibility. Cost-containment pressures in the future will necessitate the use of more process automation and innovative ways of manufacturing products. In the final analysis, these objectives can best be accomplished with the cooperation of a worldwide regulatory commitment to achieving harmonization goals for both good manufacturing practices and process validation.