Template for linearity calculations of method validations

Written by Dr. Janet Thode Posted in Method validation

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).

To facilitate evaluation of the raw data according the requirements after completion of the experiments, we’d like to provide an Excel template today for the evaluation of linearity experiments. This template includes also e.g. a RSS calculation. In addition to a simple template for entering your raw data, this document also contains an example for better illustration. However, we would like to point out that although this Excel file contains all necessary calculations, it has not been validated in the sense of csv.

 

Template for linearity calculations

 

Further calculation templates for other method validation parameters will follow soon.