A wide variety of analysis methods are used in the pharmaceutical quality control laboratory. In addition to methods to proof the identity of the active pharmaceutical ingredient and qualitative tests, quantitative determinations are also included. A (calibration) standard of different concentrations is run in parallel within each analysis and the intensity of the measurement signal (detector response) is then plotted against the concentration.

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.

And once again a technical book accompanied me on vacation and aided in avoiding my gray matter to rust completely ;-)

I’d like to use this blog article to describe my impressions of the book “Drug Development and Market Authorization” by Niels Eckstein (2^nd edition from 2018, published by Deutscher Apotheker Verlag Stuttgart, ISBN: 978-3-7692-6992-5).

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).