{"id":4028,"date":"2015-04-15T06:53:17","date_gmt":"2015-04-15T06:53:17","guid":{"rendered":"http:\/\/mirror.s-vt.net\/pq_leistungsqualifizierung\/"},"modified":"2026-10-26T12:41:02","modified_gmt":"2026-10-26T11:41:02","slug":"process-qualification","status":"publish","type":"page","link":"https:\/\/www.s-vt.net\/en\/process-qualification\/","title":{"rendered":"PQ \u2013 Performance Qualification"},"content":{"rendered":"

Performance qualification (PQ) is the documented verification that facilities, systems and equipment, as connected together, perform effectively and reproducibly based on the approved process method and product specification.<\/p>

<\/i>Connected systems<\/strong>For example production plants, filling machines or purified water systems.<\/span><\/div>
<\/i>Placebo test<\/strong>Testing based on the product specification and requirement specification.<\/span><\/div>
<\/i>Qualification report<\/strong>Final report on all qualification steps.<\/span><\/div><\/div>
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EU GMP Guide, Annex 15<\/h3>

\u201cThe documented verification that the facilities, systems and equipment, as connected together, can perform effectively and reproducibly, based on the approved process method and product specification.\u201d<\/p><\/div>

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Timing of the PQ<\/h3>

The PQ follows the completion of the OQ<\/a>. It always takes place before process validation or cleaning validation. As a rule, it concerns complex, connected systems \u2013 for example a pharmaceutical production plant, a filling machine or purified water systems<\/a>.<\/p><\/div><\/div>

Test criteria of the PQ<\/h2>

The tests are based on the approved product specification and the requirement specification<\/a>. On this basis, a placebo test is carried out, for example. Performance parameters with value ranges as well as upper and lower limits serve as criteria, such as:<\/p>