Area Qualification

Hello Dear Experts :raised_hand_with_fingers_splayed:
What is Area Qualification ?
What all test is carried out to do the Area Qualification & what all docs. we require to prepare this.
Plz share any filled report if anyone have.
Thanks in advance.

Dear ,
Area Qualification; it is the documented procedure to show that the Product/ Process, cGMP, regulatory guidelines, safety, security access, Environmental guidelines have been followed during the installation, or changes has been made in the area as per the URS.

Major Test:
1.Physical checks of the Area-Civil (Class of air, dimension, differential pressure measurement, floor specification, covings, Ceiling specification, door, wall specification),
electrical–Type of lightings, lux level,electric supply,
fire extinguisher, safety aspect–Smoke detector, nitrogen. Utilities-Purified water , steam, WFI, Compressed air,Dust collector
–Verification of AHU (supply, return, differential pressure, airflow, patterns, no… of ACPH, particulate matter, air balancing )
–Monitoring of Temperature and Relative Humidity in the Area
–Fumigation and de-fumigation of the area
–Environmental monitoring-Verification of Microbiological Monitoring of the Area



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