Design Qualification (DQ) template


A Design Qualification protocol is used at the stage where a design that has been developed from the, Validation Master Plan (VMP) or User Requirement Specification (URS) or Good Automated Manufacturing Practice (GAMP) or Good Manufacturing Practice (GMP)as well as local Health & Safety guidelines/legislation, is reviewed and documented by competent/trained person(s) to ensure that the designed equipment / process / facility, if built, will satisfy all the detailed specified user requirements.


Design Qualification (DQ)

Design Qualification is used at the stage where a design is frozen before a team of experts i.e. client and/or vendor review and documented that the designed system/equipment/facility etc., if built, will satisfy all the User Requirement Specifications (URS).

So why bother to DQ? Just think, you’ve have taken great trouble to write, and QA approve, the URS and a VP (or could be VMP), now a vendor (or could be in house Engineering) has come forward and presented a proposed design solution that they they advise will meet your business requirements i.e. GMP, HSE etc. This is where the majority of major project problems are manufactured, not obvious immediately, but materialising later in the project timeline.

The Design Qualification is the only document that is going to confirm that the design will work or, worse case, what compromises need to be made inorder to accept the design. It must be carried out by qualified/technical people who can challenge the design performance. If you have no such person(s) in your company then I’d strongly recommend you look to bring in suitably trained individual i.e. QA Validation consultant


A DQ can also be used where a company has prepared a User Requirements Specification (URS) for a piece of equipment I.E. CIP Skids and is searching for a manufacturer, but is offered equipment Of-The-Shelf i.e. HPLC. A DQ can be used to verify whether the off-the-shelf item will fully deliver the functionality detailed in the URS, and conform to the requirements specified in the VMP / GAMP5 / cGMP etc.