{"id":4030,"date":"2015-04-10T09:42:50","date_gmt":"2015-04-10T09:42:50","guid":{"rendered":"http:\/\/mirror.s-vt.net\/oq_funktionsqualifizierung\/"},"modified":"2026-10-26T12:34:02","modified_gmt":"2026-10-26T11:34:02","slug":"operational-qualification","status":"publish","type":"page","link":"https:\/\/www.s-vt.net\/en\/operational-qualification\/","title":{"rendered":"OQ – Operational Qualification"},"content":{"rendered":"

Operational qualification (OQ) is the documented proof that facilities, systems and plants, as installed or modified, function as intended throughout the anticipated operating ranges.<\/p>

<\/i>Check functions<\/strong>Compliance with the functions required in the specification.<\/span><\/div>
<\/i>Calibration<\/strong>Calibrate measuring points and define intervals.<\/span><\/div>
<\/i>Reports & records<\/strong>Test reports, logbook and OQ report.<\/span><\/div><\/div>

Definitions of operational qualification<\/h2>
<\/i>

Aide Memoire GMP<\/h3>

\u201cDocumented proof that the facilities, systems and plants, as installed or modified, function properly throughout the anticipated operating range.\u201d<\/p><\/div>

<\/i>

EU GMP Guide, Annex 15<\/h3>

\u201cThe documented verification that the facilities, systems and equipment, as installed or modified, perform as intended throughout the anticipated operating ranges.\u201d<\/p><\/div><\/div>

Contents of the OQ<\/h2>

Prerequisite:<\/strong> The IQ<\/a> has been completed successfully. The OQ then checks whether the function of the technical system matches the functionalities required in the requirement specification<\/a>.<\/p>

<\/i>

Planning & documentation<\/h3>