Method validation is a confirmatory process for the analytical procedures employed, to assess their suitability for intended use. Validation results are used to evaluate the quality, reliability and consistency of analytical methods; it is hence considered an integral part of any good analytical practice and an obligatory prerequisite for every method to be used in a pharmaceutical QC lab or associated CROs (contract research organizations) for the analysis of drugs under GMP conditions.

Has it ever occurred to you what would happen if the conditions applied during the development of an analytical method would vary? In this article we will address the same question through the parameter called robustness, which can be evaluated during method validation if not yet done earlier e.g. during method qualification.

In our blog today, we will explain the term trueness in the context of method validation, as well as its calculation, highlight its importance and provide some information about what is required.

In our blog article today, we would like to take a short look on the analytical method validation parameter “precision” and explain the different terms repeatability, intermediate precision and reproducibility.