Method Validation

Ensuring that your procedure is suitable for the analysis is important and the method validation process confirms that the analysis is the correct method for your specific tests.  Method validation means any analysis produces reliable, consistent results and importantly ones that are reproducible.

Generally speaking, any method that will be required to produce regulatory data, such as the Tobacco Products Directive, or any analysis that involves human pharmaceuticals will require a validation method. Any subsequent changes will also require a revalidation.

For example in selecting a method the following parameters will need to be considered:

  • sample type and size
  • data required (qualitative/quantitative)
  • expected level of analytes
  • expected precision and accuracy
  • any interferences
  • number and frequency of samples for analysis

The results from method validation are used to judge the quality, reliability and consistency of subsequent analytical results. A good method validation ensures the scientific accuracy of the data and is an important part of your quality control processes.