ולידציה - DQ - 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 -…
פורסם:
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