Design qualification (DQ) is the documented proof that the proposed design of facilities, systems and plants is suitable for the intended purpose.
Definitions of design qualification
Aide Memoire GMP
“Documented proof that the proposed design of the facilities, systems and plants is suitable for the intended purpose.” (Inspection of qualification and validation in pharmaceutical manufacturing and quality control)
EU GMP Guide, Annex 15
“The documented verification that the proposed design of the facilities, systems and equipment is suitable for the intended purpose.”
Risk analysis before the DQ
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.
Steps of the design qualification
- 1DQ planPreparation of a DQ plan.
- 2ProcedureDescription of the approach.
- 3Work instructionsDefinition of the work instructions.
- 4Requirement specificationPreparation of the requirement specification or tender.
- 5Risk analysisIntegration of the risk analysis results.
- 6ApprovalObtaining approvals from the client.
- 7Check functional specComparison of the supplier’s functional specification with the approved requirement specification.
- 8Check designComparison of the design documents submitted.
- 9Check functionsComparison of the functional descriptions incl. control system with the requirements.
- 10DocumentationDocumentation and approval of the execution.
The qualification process at a glance
- 1RA – Risk analysisIdentify and assess risks before the design is fixed.
- 2DQ – Design qualification (this page)Proof that the design is suitable for the intended purpose.
- 3IQ – Installation qualificationVerification of the installation against the order documents.
- 4OQ – Operational qualificationVerification of the intended functionality.
- 5PQ – Performance qualificationProof of the required performance in operation.
SEEFRIED Verfahrenstechnik GmbH prepares the design qualification documentation together with you – including the requirement specification and tender.
Frequently Asked Questions about design qualification (DQ)
What is design qualification (DQ)?
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).
Which steps are part of the DQ?
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.
Why does the risk analysis come before the DQ?
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.
What comes after the DQ?
The DQ is followed by installation qualification (IQ), operational qualification (OQ) and performance qualification (PQ).