Analytical validation according to ICH Q14 in the laboratory

Firstly, the acronym ICH Q14 refers to a guideline that describes risk-based scientific approaches for the development and maintenance of analytical procedures suitable for the quality assessment of pharmaceutical substances and products. It applies to new or revised analytical procedures used for release and stability testing of commercial pharmaceutical substances and products (chemical and biological/biotechnological). The guidance may also be applied to other analytical procedures used as part of the control strategy following a risk-based approach.

Analytical validation according to ICH Q14 therefore requires, among other things, expertise in assessing the stability of a formulation over time as well as in chemical composition analysis.

Therefore, only a laboratory with state-of-the-art analytical equipment for the analysis of pharmaceutical products is able to perform analytical validation according to ICH Q14.