ABSTRACT
Traditional pharmaceutical validation processes have relied on extensive testing throughout the life cycle of the process, equipment, or facility. Much of the testing is non-value added and does not improve the quality outcome. The foundation of the pyramid demonstrates that manufacturing processes are dependent on production and support systems being well controlled, therefore ultimately leading to protection of the patient at the top of the pyramid. A proactive partnership for QRM and validation activities begins at the process development and design phase of the ICH Q12 pharmaceutical product life cycle. As a company transitions from a drug development phase towards a process development and validation readiness phase, the risk assessment must evolve in support of that effort. The process risk assessment will incorporate inputs from the process development process and expand the failure chain to include system and component level failures. Quality risk management should be a component of the periodic review process for equipment validation.
