Process validation

What is difference between process validation and process verification???

Validation is the procedure of establishing documented evidence that provide high degree of assurance that the specific process will consistently produce a product meeting its pre-determined specification and quality attributes. This is called validation.

Verification is the comparison of results against specifications.

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Process validation: Generally 3 batches/run/cycles to be considered.
Process verification: 1 batch/run/cycle can be considered.


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