Design qualification is providing documented evidence that quality is built into the equipment design.

DQ covers all aspects of the design and procurement of facility and equipment. It is intended to encompass all those activities that might take place in the design phase, detailed and development, including activities associated with procurement of equipment and checkout at the supplier’s works.

Verification

DQ is a verification that the design meets user requirements with a particular focus on those requirements that relate to cGMP and product quality. The extent of DQ may depend on the contract arrangements.

It applies to the Equipment’s identified in the risk based impact assessment.

Purpose

The purpose of design qualification is to ensure that the equipment final design:

• Is according with all relevant specifications and design intentions mentioned in URS or Basic Specifications.
• Meets the requirements of the process, product and user.
• Adequately specifies all necessary supporting documentation.
• Complies with the requirements and principles of GMP/ GEP.
• Complies with the test points mentioned in the Risk Assessment Protocol.