IQ (Installation Qualification)
PURPOSE
IQ is to verify that the system has been installed as specified in the design, satisfying all process, utility and environment requirements. For hardware and software of the control system, verification data will be collected to prove that the proper control system has been installed as specified in the design including the requirements of 21 CFR Part 11. As IQ is the final step to formally audit and document proper installation of the system, this protocol should enable the reviewers to verify proper installation of all quality-critical components of the system. Prior to this IQ, all installation inspections and functional testing for the system must have been completed in coordination with the engineering department, construction companies and equipment suppliers through FAT (Factory Acceptance Test), SAT (Site Acceptance Test), and the subsequent testing activities during Commissioning. Any of the test data can be used as the evidence of IQ, only if such plan and data were approved through the cGMP procedures. When the IQ report is approved, the system is ready for the execution of OQ.
IQ 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