IQOQPQPhasen

IQOQPQ-Phasen, often written IQ-OQ-PQ-Phasen, describe a structured qualification framework used in regulated industries to verify that equipment, systems, and processes meet design specifications and operate within defined quality conditions. The phases are Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).

Installation Qualification verifies that equipment is installed correctly according to approved design and installation documents. Activities include site readiness, utility connections, device calibration, software/firmware versions, documentation completeness, supplier verification, and initial acceptance criteria.

Operational Qualification tests that equipment operates as intended under normal or simulated operating conditions. This covers operating ranges, control logic, alarms and interlocks, safety features, software operation, parameter limits, and routine maintenance checks.

Performance Qualification confirms that the equipment or system delivers the expected output under real production conditions with actual materials and operators. It relies on predefined acceptance criteria and generates evidence of repeatable, quality-assuring performance, often via production-scale runs or process simulations.

IQOQPQ-Phasen are part of a broader validation and quality system aligned with GMP and regulatory expectations. They are typically documented in qualification master plans and IQ/OQ/PQ protocols, with results reviewed by quality assurance and maintained under change control; guidelines emphasize risk-based planning and traceability.

Beyond pharmaceuticals, the approach is used in biotech, medical devices, and facility utilities. The specific scope and stringency depend on risk assessment and critical quality attributes, but the core idea remains ensuring that equipment and processes reliably meet requirements.