Operational Qualification (OQ) vs. Performance Qualification (PQ) in Validation

In regulated industries like pharmaceuticals, medical devices, and biotechnology, validation is paramount. It’s the documented proof that a process, system, or piece of equipment consistently produces results meeting predetermined specifications and quality attributes. Within the broader validation lifecycle, two critical stages often cause confusion: Operational Qualification (OQ) and Performance Qualification (PQ). While both are essential for ensuring quality and compliance, […]