Method validation in pharmaceutical analysis: from theory to practical optimization

Industrial Management Consulting
Industrial Management Consulting

Analytical methods can be considered as a complex and multi-step issue, ranging from sampling to  generating the result. It is internationally recognized that the validation of methods is required to obtain high-quality data.1

According to Araujo (2009),2 the word valid – from the Latin validus – means strong. To validate means to officially state that something that has been proven to be true is useful and of an acceptable standard.

The validation of analytical procedures intends to establish the performance characteristics of analytical applications through experimental tests, resulting in a suitable analytical
method for its purpose.3

Considerations about method validation have been highlighted since the late 1940s when mathematics and statistics were considered to be essential prerequisites for the development of analytical methods. Its implementation in  analytical laboratories was established in the late 1970s, reflecting the recognition of this process as an important way of obtaining standard methods. Currently, several
international organizations are committed to continuous processing improvement.

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