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ISPE Glossary of Pharmaceutical and Biotechnology Terminology
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Operational Qualification (OQ)
Documented verification that all aspects of a facility system which can affect product quality, performs as intended throughout all anticipated operating ranges.
Publication Source: ISPE Baseline® Guide, Vol. 3: Sterile Manufacturing Facilities (First Edition)
Publication Date: 2011
Operational Qualification (OQ)
(FDA) Establishing confidence that process equipment and sub-systems are capable of consistently operating within established limits and tolerances.
Publication Source: FDA Glossary of Computerized System and Software Development Technology
Operational Qualification (OQ)
The documented verification that the facilities, systems and equipment, as installed or modified, perform as intended throughout the anticipated operating ranges.
Publication Source: ISPE Good Practice Guide: Applied Risk Management for Commissioning and Qualification
Publication Date: 2011
Operational Qualification (OQ)
Documented verification that a system operates according to written and pre-approved specifications throughout all specified operating ranges.
Publication Source: GAMP® 4: Good Automated Manufacturing Practice Guide for Validation of Automated Systems
Operational Qualification (OQ)
For “Direct Impact” systems, the documented verification that all aspects of a facility, utility, or equipment that can affect product quality, perform as intended throughout all anticipated operating ranges.
Publication Source: ISPE Good Practice Guide: Commissioning and Qualification of Pharmaceutical Water and Steam Systems
Publication Date: 2007
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