Joachim Ermer

Analytical methods are used throughout the development, manufacture and release of pharmaceutical substances and dosage forms. The accuracy and reliability of analytical results are therefore essential. Successful method validation proves that the test procedure is suitable for the defined application. In today's feature, Joachim Ermer writes about the regulatory requirements for the validation of analytical methods. 

In the next LOGFILE you will learn more about important aspects of putting these requirements into practice.

Analytical methods are used throughout the development, manufacture and release of pharmaceutical substances and dosage forms. The accuracy and reliability of analytical results are therefore essential. Successful method validation proves that the test procedure is suitable for the defined application. In our last feature, we reported on the regulatory requirements for analytical method validation. Today, you can find out which aspects need to be considered when putting them into practice.

How does the draft ICH Q1 guideline affect the stability study design and conduct of drug products and drug substances? Joachim Ermer, PhD, summarises the most important changes and comments on critical aspects.