WATERS USED FOR PHARMACEUTICAL MANUFACTURING AND TESTING PURPOSESWATERS USED FOR PHARMACEUTICAL MANUFACTURING AND TESTING PURPOSES
Periodic Review and RequalificationRequalification shall be carried out to ensure the equipment should be maintained in a qualified state throughout the life-cycle of the same
Performance Qualification [PQ]To check the equipment etc. operates consistently & gives reproducibility within defined specifications & parameters, for prolonged periods
Operational Qualification [OQ]Operational Qualification: Documented verification that the system or subsystem performs as intended overall anticipated operating ranges.
Installation Qualification [IQ]The performance of tests to ensure that the system etc. used in a manufacturing process are appropriately selected and correctly installed.
Site Acceptance Test [SAT]Site Acceptance Test [SAT] A test conducted at the manufacturer’s site of use, to verify that the system is meets approved specifications.