Pharmaceutical Validation and Process Controls in Drug Development

Abstract

In drug development, pharmaceutical validation and process controls are important to assure that the drug product can meet standards for the identity, strength, quality, purity, and stability of the drug product. Pharmaceutical validation includes analytical method validation and (manufacturing) process validation. A validated analytical method is often employed for product testing at various critical stages of a manufacturing process to evaluate whether the manufacturing process does what it purports to do. For a validated manufacturing process, the current good manufacturing practice requires that a well-written procedure for process controls be established to monitor the performance of the manufacturing process. In this paper, statistical issues and regulatory requirements for pharmaceutical validation and process controls in drug development are discussed. The concept can be applied to new drugs, new dosage forms, and generic drug development.