Design Qualification (DQ)

EU GMP Guidelines Annex 15: Qualification and Validation provides the following definition of Design Qualification (DQ):

“Design qualification (DQ): The documented verification that the proposed design of the facilities, systems and equipment is suitable for the intended purpose.”

Annex 15 also defines User requirements specification (URS) and its connection with DQ as follows:

“12. Glossary …User requirements Specification (URS): The set of owner, user and engineering requirements necessary and sufficient to create a feasible design meeting the intended purpose of the system.”

“3.2. The specification for equipment, facilities, utilities or systems should be defined in a URS and/or a functional specification. The essential elements of quality need to be built in at this stage and any GMP risks mitigated to an acceptable level. The URS should be a point of reference throughout the validation life cycle.”

“3.3. The next element in the qualification of equipment, facilities, utilities, or systems is DQ where the compliance of the design with GMP should be demonstrated and documented. The requirements of the user requirements specification should be verified during the design qualification.”

In practice, during Design Qualification, compliance with several types of requirements is actually verified simultaneously:

Requirements of GMP Guidelines
Process requirements (including those related to product characteristics)
User (customer, client) requirements – i.e., the requirements of the User Requirements Specification (URS) – some of which may not be related to the first two types of requirements above.

Compliance of the system design is verified by reviewing project documentation, equipment specifications, and similar materials. Design Qualification is the final stage of validation activities, during which only documentation is checked. In all subsequent stages of qualification, the actual equipment/systems are involved.

The verification is conducted based on a pre-prepared qualification protocol with control points and predefined acceptance criteria, typically formatted in a table. Before the qualification is conducted, the protocol must be approved for use, and no changes to the control points and acceptance criteria wording are allowed during the qualification process.

During the verification, the protocol is completed, and after checking all control points, a qualification report is prepared, which may either be the completed qualification protocol or a report formatted as a separate document.

Design Qualification (DQ) is the stage of validation activities most closely related to the facility design phase.

The specialists at Tarqvara Pharma Technologies have years of experience in conducting qualification, validation, and acceptance tests within the pharmaceutical industry, in full compliance with international, European, and national GMP/GxP regulations and standards.