Definition:
Validation is study of systems,
facilities, processes or method aimed at determining whether they perform their
intended functions adequately and consistently as specified.
Validation is an integral part of
quality assurance
Validation in itself does not improve processes but confirms
that the processes have been properly developed and are under control.
Reason for Validation:
- It deepens the understanding of processes
- Decreases the risk of preventing problems and thus assures the smooth running of the process.
- It decreases the risk of defect costs.
- It decreases the risk of regulatory noncompliance.
- A fully validated process may require less
in-process controls and end product testing.
Validation should thus be considered
in the following situations:
- Totally new process (Process Validation )
- New equipment (Qualification is also the part of the validation.)
- Process and equipment which have been altered to suit changing priorities
- Process where the end-product test is poor and an unreliable indicator of product quality
- process utility system (water, AHU, HVAC),
- Any analytical test method,
- Cleaning procedure
- Computer system
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