Glossary
Operational Qualification (OQ)
The stage that tests whether equipment or a system operates as designed throughout the defined operating range and at worst case conditions.
Details
Operational qualification tests that installed equipment and systems operate as designed across the whole defined operating range and at worst case conditions; it sits between IQ, which checks the installed state, and PQ, which looks at process performance with real materials. EU GMP Annex 15 §3.11 requires tests developed from knowledge of the process, system, and equipment, and tests confirming the upper and lower operating limits and worst case conditions, and §3.12 requires standard operating and cleaning procedures, operator training, and preventive maintenance requirements to be finalised only after OQ has been successfully completed (for simple equipment IQ and OQ may be combined as IOQ, §3.10). Inspections cite testing at the normal set point alone with both ends of the range and the worst case omitted, no testing of alarms, interlocks, or power failure recovery, procedures approved and used in production before OQ was complete, and failed tests covered by a retest with no deviation raised.
Related sections
Related terms
Real inspection findings
Findings from regulators' inspection documents in which this term appears.
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The Validation Master Plan (VMP) document #VM/QA/01 establishes the Installation and Operational Qualifications {1/OO) reauirements (i.e., “build and installed in compliance with their design specifica- tions”.
FDA · FDA 483 · 2017-10-19 -
Your firm failed to conduct appropriate qualification (DQ, IQ, OQ & PQ) of critical equipment.
FDA · FDA 483 · 2018-06-28 -
Your firm did not establish appropriate visual inspection (VI) procedures designed to assure batches oq {tiff4lproducts meet the specifications and quality control criteria as a condition for their approval and release.
FDA · FDA 483 · 2025-03-28
