Glossary
Design Qualification (DQ)
The stage that documents and demonstrates that the design of a facility, equipment, utility, or system meets GMP and the user requirements.
Details
Design qualification is the first stage of qualification: before installation, it documents that the design of the equipment, facility, utility, or system meets GMP and the user requirements specification — it asks whether the requirements were carried into the design, before IQ asks whether it was installed as drawn, OQ whether it works as designed, and PQ whether it performs in practice. EU GMP Annex 15 §3.3 requires that the requirements of the URS be verified during DQ, and §§3.4–3.7 allow documentation and tests confirmed at factory acceptance testing and site acceptance testing not to be repeated at IQ/OQ where it can be shown that transport and installation did not affect functionality. Inspections cite a supplier's specification used as the DQ in place of a URS, no traceability between URS items and what DQ verified, and design changes carried into IQ without being reflected in the DQ.
