15/08/2022
Did you know…The ICH recently published two draft guidelines on analytical methods.
ICH Q14 is a brand new guideline on analytical procedure development. It’s built on the same concept as ICH Q8 and can be summed up like this: The more you know about your analytical method, the more likely it will be appropriate for its intended use, and you can expect more flexibility from the regulator.
Meanwhile, the ICH Q2 on analytical validation was significantly revised and updated. Many of the definitions used in the previous version have been changed, to correlate more with ICH Q8. They clarified that method validation is an ongoing process, and offered a lot of examples of validation study methodologies. For people who like analytics, this was a fun update.
