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“Design qualification” (DQ) is carried out during the review stage of a developed project, when it is documented by competent professionals to ensure that the designed equipment will satisfy all the detailed specified requirements and the current European GMP regulations.
According to GMP Annex 15, conformance of the design with requirements should be demonstrated and documented.
The “DQ” encompasses the documentation of the planning phase including the decision as to which facility will be used.
The “DQ” takes place before the equipment is constructed. The risk analysis is often part of the “DQ”. Recording and evaluating risks early provides the opportunity to eliminate or minimise the risks when planning the location and equipment needs, based on the customer’s URS.
To this end, the requirements laid out in the user requirements are compared with the specifications compiled by the supplier (technical specifications) and confirmed in writing.