{"id":4032,"date":"2015-04-08T10:55:42","date_gmt":"2015-04-08T10:55:42","guid":{"rendered":"http:\/\/mirror.s-vt.net\/dq_designqualifizierung\/"},"modified":"2026-10-26T12:26:01","modified_gmt":"2026-10-26T11:26:01","slug":"design-qualification","status":"publish","type":"page","link":"https:\/\/www.s-vt.net\/en\/design-qualification\/","title":{"rendered":"DQ – Design Qualification"},"content":{"rendered":"

Design qualification (DQ) is the documented proof that the proposed design of facilities, systems and plants is suitable for the intended purpose.<\/p>

<\/i>Documented proof<\/strong>Design and intended purpose compared in a traceable way.<\/span><\/div>
<\/i>Risk analysis first<\/strong>Identify risks before the design is fixed.<\/span><\/div>
<\/i>Requirement vs. functional spec<\/strong>Systematic comparison with the supplier documents.<\/span><\/div><\/div>

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

Aide Memoire GMP<\/h3>

\u201cDocumented proof that the proposed design of the facilities, systems and plants is suitable for the intended purpose.\u201d (Inspection of qualification and validation in pharmaceutical manufacturing and quality control)<\/p><\/div>

<\/i>

EU GMP Guide, Annex 15<\/h3>

\u201cThe documented verification that the proposed design of the facilities, systems and equipment is suitable for the intended purpose.\u201d<\/p><\/div><\/div>

Risk analysis before the DQ<\/h2>

A comprehensive risk analysis of the project is usually carried out before the design qualification. It reveals risks before the design, so that they can be weighted and taken into account at the design stage. This ensures high process reliability and largely rules out possible sources of error in advance.<\/p>

Steps of the design qualification<\/h2>
  1. 1<\/span>DQ plan<\/strong>Preparation of a DQ plan.<\/span><\/li>
  2. 2<\/span>Procedure<\/strong>Description of the approach.<\/span><\/li>
  3. 3<\/span>Work instructions<\/strong>Definition of the work instructions.<\/span><\/li>
  4. 4<\/span>Requirement specification<\/strong>Preparation of the requirement specification<\/a> or tender.<\/span><\/li>
  5. 5<\/span>Risk analysis<\/strong>Integration of the risk analysis results.<\/span><\/li>
  6. 6<\/span>Approval<\/strong>Obtaining approvals from the client.<\/span><\/li>
  7. 7<\/span>Check functional spec<\/strong>Comparison of the supplier\u2019s functional specification with the approved requirement specification.<\/span><\/li>
  8. 8<\/span>Check design<\/strong>Comparison of the design documents submitted.<\/span><\/li>
  9. 9<\/span>Check functions<\/strong>Comparison of the functional descriptions incl. control system<\/a> with the requirements.<\/span><\/li>
  10. 10<\/span>Documentation<\/strong>Documentation and approval of the execution.<\/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 (this page)<\/strong>Proof that the design is suitable for the intended purpose.<\/span><\/li>
    3. 3<\/span>IQ \u2013 Installation qualification<\/a><\/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 IQ \u2013 Installation qualification <\/i><\/a><\/div>

      SEEFRIED Verfahrenstechnik GmbH<\/strong> prepares the design qualification documentation together with you \u2013 including the requirement specification and tender.<\/p>

      Frequently Asked Questions about design qualification (DQ)<\/h2>

      What is design qualification (DQ)?<\/h3>

      DQ is the documented verification that the proposed design of facilities, systems and equipment is suitable for the intended purpose (EU GMP Guidelines, Annex 15).<\/p>

      Which steps are part of the DQ?<\/h3>

      Among others: DQ plan, description of the procedure, requirement specification or tender, integration of the risk analysis, comparison of functional specification, design documents and functional descriptions with the requirement specification, as well as documentation and approval.<\/p>

      Why does the risk analysis come before the DQ?<\/h3>

      It identifies risks before the design so they can be addressed in the design. This increases process safety and largely eliminates sources of error in advance.<\/p>

      What comes after the DQ?<\/h3>

      The DQ is followed by installation qualification (IQ), operational qualification (OQ) and performance qualification (PQ).<\/p>

      Talk to us<\/h2>
      We are happy to advise you on design 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>IQ \u2013 Installation qualification<\/span><\/i><\/a>OQ \u2013 Operational qualification<\/span><\/i><\/a>PQ \u2013 Process qualification<\/span><\/i><\/a>Process optimisation<\/span><\/i><\/a><\/div>