DQ
Design Qualification
What a definition is not
A definition is SPEQ’s plain-language decode of how a term is used in practice, cited to the documents that define it. It is a practitioner reference, not legal or regulatory advice, it does not replace the definition in the source, and where a regulator’s wording differs the regulator’s wording governs.
Design Qualification is the documented verification, before purchase or build, that the proposed design of a facility, system, or equipment meets the user requirements and GMP expectations. It is the first qualification stage and the point at which requirements are confirmed to be met on paper, before anything is installed.
DQ traces each item in the User Requirements Specification (URS) to the vendor design/functional specification, confirming every GMP-critical requirement is designed in. Catching a gap at DQ is far cheaper than discovering it at IQ/OQ after the equipment is on site.
In the ASTM E2500 / ISPE C&Q verification model, the equivalent activity is a design review that identifies critical aspects and confirms the design addresses them, feeding forward into commissioning and qualification.
- —First stage: verifies design against the URS before build/purchase.
- —Traces GMP-critical requirements to the design specification.
- —Precedes IQ, OQ, and PQ.
- —Equivalent to design review in the ASTM E2500 verification model.
EU GMP Annex 15 (2015), Design Qualification section; ASTM E2500-25 design review.
Frequently asked questions
What does DQ stand for?
DQ stands for Design Qualification.
What is DQ?
Design Qualification is the documented verification, before purchase or build, that the proposed design of a facility, system, or equipment meets the user requirements and GMP expectations. It is the first qualification stage and the point at which requirements are confirmed to be met on paper, before anything is installed.
Which regulations cover DQ?
EU GMP Annex 15 (2015), Design Qualification section; ASTM E2500-25 design review.