WEBINAR | Validation: Beyond The Trilogy

Across the pharmaceutical, biopharmaceutical and medical device industries, process validation has historically been structured around the trilogy:

1. Process Design: Develop and understand the process based on science, risk, and data (Stage 1)
2. Process Qualification: Confirm the process performs as intended at scale, including qualification of equipment, facilities, utilities, and performance qualification (PPQ) (Stage 2)
3. Continued Process Verification (CPV): Ongoing monitoring during routine production to ensure the process remains in a state of control (Stage 3)

These stages are interdependent, with no isolated checkpoints, and are foundational to an effective quality system.

Why Move “Beyond the Trilogy”?

While the three-stage model remains the backbone of process validation, regulators worldwide now emphasise a lifecycle approach; one that treats process validation not as a one-time milestone, but as a continuous, data-driven assurance activity.

Register to watch our webinar on-demand to learn more about how the lifecycle approach creates a feedback loop where CPV informs design and qualification repeatedly.