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Method validation

Definition:

Method validation is the process used to confirm that the analytical procedure employed for a specific test is suitable for its intended use. Results from method validation can be used to judge the quality, reliability and consistency of analytical results; it is an integral part of any good analytical practice.

Source: Ludwig Huber, Validation and Qualification in Analytical Laboratories 

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Analytical methods need to be validated or revalidated

  • before their introduction into routine use;
  • whenever the conditions change for which the method has been validated (e.g., an instrument with different characteristics or samples with a different matrix); and
  • whenever the method is changed and the change is outside the original scope of the method.

Source: Ludwig Huber, Validation and Qualification in Analytical Laboratories 


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