{"id":4031,"date":"2015-04-08T13:06:32","date_gmt":"2015-04-08T13:06:32","guid":{"rendered":"http:\/\/mirror.s-vt.net\/iq_installationsqualifizierung\/"},"modified":"2026-10-26T12:29:18","modified_gmt":"2026-10-26T11:29:18","slug":"installation-qualification","status":"publish","type":"page","link":"https:\/\/www.s-vt.net\/en\/installation-qualification\/","title":{"rendered":"IQ – Installation Qualification"},"content":{"rendered":"

Installation qualification (IQ) is the documented proof that facilities, systems and plants, as installed or modified, comply with the approved design and the manufacturer\u2019s recommendations.<\/p>

<\/i>Completeness<\/strong>Check whether all installations of the system are complete.<\/span><\/div>
<\/i>Comparison with the DQ<\/strong>Drawings, diagrams, plans and parts lists against the approved design.<\/span><\/div>
<\/i>Documented compliance<\/strong>Traceable documentation for GMP qualification.<\/span><\/div><\/div>

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

Aide Memoire GMP<\/h3>

\u201cDocumented proof that the facilities, systems and plants, as installed or modified, comply with the approved design and the manufacturer\u2019s recommendations.\u201d<\/p><\/div>

<\/i>

EU GMP Guide, Annex 15<\/h3>

\u201cThe documented verification that the facilities, systems and equipment, as installed or modified, comply with the approved design and the manufacturer\u2019s recommendations.\u201d<\/p><\/div><\/div>

How the IQ check works<\/h2>
  1. 1<\/span>Installation status<\/strong>The basis is the status of the system\u2019s installations and their completeness.<\/span><\/li>
  2. 2<\/span>Completeness check<\/strong>Comparison with the DQ design<\/a>, drawings, diagrams, plans, parts lists and the requirement<\/a> and functional specifications.<\/span><\/li>
  3. 3<\/span>Comparison with the system<\/strong>The test results are compared with the approved system.<\/span><\/li>
  4. 4<\/span>Documentation<\/strong>Compliance with the DQ documents is documented.<\/span><\/li><\/ol>

    The qualification process at a glance<\/h2>
    1. 1<\/span>RA \u2013 Risk analysis<\/strong>Identify and assess risks before the design is fixed.<\/span><\/li>
    2. 2<\/span>DQ \u2013 Design qualification<\/a><\/strong>Proof that the design is suitable for the intended purpose.<\/span><\/li>
    3. 3<\/span>IQ \u2013 Installation qualification (this page)<\/strong>Verification of the installation against the order documents.<\/span><\/li>
    4. 4<\/span>OQ \u2013 Operational qualification<\/a><\/strong>Verification of the intended functionality.<\/span><\/li>
    5. 5<\/span>PQ \u2013 Performance qualification<\/a><\/strong>Proof of the required performance in operation.<\/span><\/li><\/ol>
      Continue to OQ \u2013 Operational qualification <\/i><\/a><\/div>

      SEEFRIED Verfahrenstechnik GmbH<\/strong> supports you with the documentation requirements and the verification of the installation qualification.<\/p>

      Frequently Asked Questions about installation qualification (IQ)<\/h2>

      What is installation qualification (IQ)?<\/h3>

      IQ is the documented verification that facilities, systems and equipment, as installed or modified, comply with the approved design and the manufacturer\u2019s recommendations (EU GMP Guidelines, Annex 15).<\/p>

      What is checked during IQ?<\/h3>

      Based on the DQ, the technical documents (drawings, diagrams, plans, parts lists) and the requirement and functional specifications, the installation is checked for completeness and compared with the approved system.<\/p>

      What is the result of the IQ?<\/h3>

      Documentation that the installed plant complies with the DQ documents. It is the prerequisite for the subsequent operational qualification (OQ).<\/p>

      How do you support us?<\/h3>

      We support you with documentation requirements and the execution and review of the IQ.<\/p>

      Talk to us<\/h2>
      We are happy to advise you on installation qualification \u2013 by phone at +49 4203 789492<\/a> or by e-mail at info@s-vt.net<\/a>.<\/div>
      Send an enquiry<\/a>All services<\/a><\/div><\/div>

      More services<\/h2>
      Planning<\/span><\/i><\/a>Basic engineering<\/span><\/i><\/a>Design & construction support<\/span><\/i><\/a>Procurement support<\/span><\/i><\/a>Requirement specifications for process plants<\/span><\/i><\/a>Schedule planning & monitoring<\/span><\/i><\/a>Construction supervision<\/span><\/i><\/a>DQ \u2013 Design qualification<\/span><\/i><\/a>OQ \u2013 Operational qualification<\/span><\/i><\/a>PQ \u2013 Process qualification<\/span><\/i><\/a>Process optimisation<\/span><\/i><\/a><\/div>