This video is about Equipment Qualification Lifecycle
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Life cycle of equipment qualification/validation
Kirtiman Paikray
Wednesday, March 21, 2018, 08:00 Hrs [IST]
Qualification/validation can be defined as “establishing documented evidence which provides a high degree of assurance that specific equipment procured will consistently produce its predetermined specification and quality attributes”.
Validation was a term established by the FDA to obligate pharma/nutra companies to prove the control and reproducibility of their manufacturing process.
The FDA wanted industries to demonstrate statistically and with a scientific basis that the process was sound, reproducible and under control. Validation is intended to be the mechanism by which quality could verify manufacturing.
Qualification term is qualifying an equipment/system/utility/instrument based on URS. Validation comes in picture during the involvement of any parameters used to run the equipments/utilities/systems in as sequence.
The life cycle of the qualification is divided into following steps: Project Validation Plan; (PVP). User Requirement Specification (URS); Design Qualification (DQ); Risk Assessment/Risk Management (RA/RM); Factory Acceptance Test (FAT); Site Acceptance Test (SAT); Installation Qualification (IQ); Operational Qualification (OQ); Performance Qualification (PQ).
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