FDA Lifecycle Approach to Process Validation

FDA lifecycle approach approach described in the guidance integrates various strategies, approaches, and expectations that had been mentioned in several previously published documents, guidelines, and presentations. The concepts identified in the respective stages of the FDA process validation guidance—understanding, performance, and main¬tenance—serve as a model for all areas of validation. Implementation of the lifecycle approach in site validation programs has significant ramifications for the organization. Organizational functions previously “distant” from commercial processes are now integral to ongoing performance. Post-validation monitoring of process performance including timely responsiveness to data trends is an expectation. The lifecycle approach affects many areas of validation programs including organizational aspects, validation performance guidance specifics, risk analysis, training, and documentation. Senior and functional management support is needed to transition organizations to the lifecycle approach to validation. Risk analysis is key to development and prioritization of a suitable validation program that will be embraced and supported.