The first step of production validation (equipment, etc.) is qualification of design documentation (Design Qualification – DQ).
Design Qualification (DQ) is the process of documented confirmation that the design of a production area (engineering system, equipment, etc.) complies with the User Requirement Specification (URS) and with GMP requirements.
Design Qualification (DQ) is aimed at:
- analysis of project concept and fundamental idea;
- assessment of compliance with GMP requirements;
- determination of possibility of further qualification and validation steps implementation;
- reduction of risks significance level for subsequent phases of project implementation (according to the system of risk management and risk analysis in the process of validation).
Design Qualification (DQ) is a mandatory qualification phase.
In most cases it is feasible to qualify the concept design first, and then the detailed design.
Design Qualification (DQ) must be completed before construction of the designed facility is begun.
Depending on the role and significance of the qualification object a team of experts is collected. For example, if the object of design qualification is equipment, it is sufficient to perform an expert comparison of equipment manufacturer's specification with the design requirements and confirm if the equipment complies with these requirements.
Of course, qualification of a greenfield integrated production facility will require more powerful resources. A team of experts independent from the design contractor is established in order to confirm the design documentation and verify that the systems and equipment operate as an integrated facility.
Key items of design qualification (DQ) for products manufacturing (drugs, etc.) are:
- verification of process steam-lining;
- minimizing contamination risks;
- arrangement of personnel and material flows;
- correctness of assigned clean room grades;
- pressure differentials between rooms;
- possibility to clean the equipment and rooms efficiently;
- keeping rooms with identical cleanliness grade as close as possible;
- rational layout of equipment and materials to prevent mix-up of various types and lots of feed stock, packaging and marking materials, etc.
An essential condition for efficient design qualification (DQ) is availability of a clearly defined User Requirement Specification (URS)..
Design Qualification (DQ) is performed based on the drawn up Qualification Plan that provides a detailed description of:
- qualification test procedures;
- acceptance criteria;
- list of used equipment;
- assessment procedures, etc., for qualification protocols whose structure, test procedures, assessment criteria fully comply with GMP requirements.
In the process of design qualification (DQ) a Qualification protocol is drawn up that reflects all qualification results. The protocols contain a complete program of performed checks and procedure for documenting the obtained results. As a result of analysis and obtained data a design qualification (DQ) report is drawn up; after that it is possible to move to the next phase, i.e. Installation Qualification (IQ).
