The ICH Q14 guideline lays the basis for the application of Quality by Design (QbD) to analytical methods and represents a paradigm shift from traditional deterministic method development to flexible, science-based systems. The rigid approach of traditional method development has limited flexibility, hindered innovation and made it difficult to adapt analytical strategies to new scientific findings or technological advances.
We are pleased that the article “ICH Q14 and the paradigm shift in pharmaceutical analytics” by Dr Alexander H. Schmidt and Mijo Stanic has been published in GMPJournal and gives us the opportunity to offer you a deeper insight into this ground-breaking development in analytics.
At this point, we would like to draw your attention to the event ‘ICH Q14 – Development of Analytical Methods’, which will take place from 23 to 25 September 2025 at Chromicent in Berlin Adlershof. Further information can be found *here*
