WATERS USED FOR PHARMACEUTICAL MANUFACTURING AND TESTING PURPOSES
WATERS USED FOR PHARMACEUTICAL MANUFACTURING AND TESTING PURPOSES
Qualification
8 articles tagged “Qualification”
Periodic Review and Requalification
Periodic review and requalification: Periodic review and requalification shall be carried out to ensure the Utilities and equipment should be maintained
Performance Qualification (PQ): Protocol, Steps & Examples
To check the equipment etc. operates consistently & gives reproducibility within defined specifications & parameters, for prolonged periods
Operational Qualification (OQ): Protocol, Tests & Examples
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.
Factory Acceptance Test (FAT) in Pharma: Checklist & Scope
Factory Acceptance Test (FAT) for Equipment, Utility, System, Facility in the pharmaceutical industry.
Basic Flow of Qualification [Equipment, Utility, System, Facility] in Pharmaceutical Industry
Basic Flow of Qualification [Equipment, Utility, System, Facility], URS, DQ, FAT, SAT, IQ, OQ, PQ