what is the relation between cleaning,method and system validation

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lakshminarayana
lakshminarayana's picture
what is the relation between cleaning,method and system validation

hai this is laksminarayana can you explain how to differ cleanig ,method and system validation .

Dr. Analytical
Dr. Analytical's picture
You should search the web

You should search the web sites of regulatory agencies for more information about each of these activities, or find a regulatory expert who can answer them in more detail.

"Validation" is the procedures that you perform to verify that something can operate as expected.  Validation provides the data for this proof.

So, cleaning validation will verify that your equipment does not have residue from the manufacturing process after it has been cleaned (so that it does not contaminate the next batch).

Method validation provides data about how well an analytical method will perform - accuracy, reproducibility, ruggedness.

System validation verifies that your equipment is performing within the specifications set by the manufacturer.

Each procedure has different requirements and involves different experiments.