Quality Control

Pharmaceutical analysis in drug development mainly focuses on methods to identify and quantify potential new drug candidates, determine purity, identify by – products and degradation products in compatibility and stability studies, and to determine the drug substance’s fate in the organism. Challenging tasks like these require sophisticated techniques, dedicated equipment and methods operated by highly skilled staff, often with a good academic background.

The challenges that have to be faced in pharmaceutical quality control are different – techniques and methods must be well established and recognised. Robustness, not brilliance is the main feature to be accomplished by laboratories running under time and cost pressure using routine equipment operated by varying levels of experienced staff.

Accordingly, a review and the subsequent assessment of the developments in pharmaceutical analysis will generate different results when performed under this perspective.