If you are just approaching the topic of method validation, you may be faced with the question which analytical methods are actually affected by method validation.

To answer this question, we have to clarify which methods are used when and for what purpose.

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).