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]:

An important aspect that - depending on the type of method - is evaluated during method validations according to the ICH Q2(R1) guideline is precision. This includes repeatability as well as intermediate precision (inter-assay precision).

Intermediate precision examines the variability of the results, which are obtained under changing conditions common in the laboratory. This includes different laboratory technicians who are performing the method, different days on which the method is done and / or different instruments that are used for analysis (e.g. 2 different photometers). To examine these different aspects, you can either consider each aspect individually or you can apply the so-called "matrix approach" (experimental design) for intermediate precision, which kills all aspects with one stone ;-)

In the highly regulated pharmaceutical environment, documentation is always associated with a little more effort... This also applies to the creation of necessary documents required for laboratory methods. Before an analytical method is allowed to be used in a QC laboratory for the first time, it prior must be validated.