During method validations in pharmaceutical QC laboratories or commissioned contract laboratories, different validation parameters have to be checked. For quantitative impurity determinations and assays, such as content determinations of the active pharmaceutical ingredient or potency tests, studies of the linearity are required according to the method validation guideline ICH Q2(R1).

When evaluating quantitative analytical quality control methods regarding their fitness for purpose during method validation, the validation parameter “intermediate precision” must also be considered. The term “intermediate precision” might also appear under the following names:

Templates make life easier. This is true in every field of life. Since this blog is about topics in pharmaceutical laboratories, especially method validation, method verification and method transfer, we have started to provide templates for the validation of analytical methods according to ICH Q2(R1) considering their method type (identification method, impurity test or assay).

Why does it make sense to determine "accuracy" and "precision" during method validations? What’s behind? And how are the terms "trueness", "accuracy" and "precision" related to each other?

According to the method validation guideline ICH Q2(R1), only “accuracy” and precision must be determined during method validations. They are defined in ICH Q2(R1) as follows [1]: