Design qualification (DQ; German: Designqualifizierung): Documented evidence in the pharmaceutical industry that the proposed design or planning of the production facilities, equipment or systems is suitable for the intended purpose.

Key aspects of design qualification (DQ):

• Risk analysis: As part of the DQ, a risk analysis (German translation: Risikoanalyse) is carried out in order to evaluate and describe the critical performance parameters of equipment, systems and facilities. This includes identifying potential risks and developing measures to minimize them.
• Consideration of cleaning validation and process validation: The DQ also takes cleaning validation and process validation into account. Cleaning validation ensures that the cleaning process maintains the required cleanliness of the pharmaceutical production facilities. Process validation (translation into German: Prozessvalidierung) ensures that the manufacturing process is reproducible and efficient.
• Relationship to installation qualification (IQ), operational qualification (OQ) and performance qualification (PQ): DQ is the initial phase that forms the basis for the subsequent qualification phases, including the IQ (validation of the correct installation of the system), the OQ (validation of the function of the equipment in various operating modes) and the PQ (validation of the efficiency and reproducibility of the system operation as a whole).
• Change control (German translation: Änderungskontrolle): This aspect ensures that all changes to installations, equipment, systems or processes are checked by qualified individuals and that the system is maintained in a validated state.
• Types of validation: DQ takes into account various types of validation, including prospective, recurring and retrospective validation, which are important for the quality assurance of processes and products at various stages of development and change.
• System approach: The DQ is seen as part of a complex system that encompasses a whole range of equipment and processes to achieve the ultimate goal of efficient and safe production of drugs.

Design qualification (DQ) therefore involves an in-depth and multi-dimensional analysis to ensure that the design solutions meet the objectives and requirements of pharmaceutical production. Design qualification is the first and one of the most important steps in the entire validation process, as it ensures that the foundation for all subsequent steps is laid correctly and meets all requirements.

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