ולידציה – DQ – Design Qualification / Design Review
DQ – Design Qualification is for Design Review by verifying that the system has been designed as specified in the URS (User Requirements Specification), FDS (Functional Design Specification), and relevant equipment specifications satisfying all GMP requirements. The Process User Requirements in the URS have been identified by the Quality Risk Assessment. Since the Quality Risk Assessment is an iterative process, it may be performed again, whenever necessary, during the DQ and subsequent lifecycle qualifications. For hardware and software of the control system, verification data will be collected to prove that the system has been designed in accordance with the URS and FDS including the requirements of 21 CFR Part 11. As DQ is the final step to formally review and document the proper design of the system, the protocol must enable the reviewers to verify that all quality-critical attributes and essential technical attributes of the system have been incorporated in the design. When the DQ report is approved, the system is ready for fabrication and construction.
DQ PROTOCOLS
PROCESS EQUIPMENT AND SYSTEMS
Media Preparation and Hold Tanks
Buffer Preparation and Hold Tanks
Process Tanks
Reactors – Organic Synthesis
Bioreactors
Evaporator Systems
Distillation Tower Systems
CLEAN UTILITY SYSTEMS
USP Purified Water Storage and Distribution Systems
WFI Storage and Distribution Systems
Clean Steam Generation and Distribution Systems
Process Air Systems
Nitrogen Gas Systems
SUPPORT SYSTEMS
CIP Systems
Biowaste Kill Systems – Continuous
Biowaste Kill Systems – Batch
Autoclaves
HVAC SYSTEMS AND CLEANROOMS
HVAC Systems
Cleanrooms – Aseptic
Air Locks – Gowning
LABORATORY EQUIPMENT
Incubators
CO2 Incubators
Water Bath Incubators
Ultra-Low Temperature Freezers
Refrigerators
