Method Validation and Transfer with focus on the new ICH Q2(R2) MasterClass

The new draft ICH guideline for method validation ICHQ2(R2) has been published for comment. Together with the new ICHQ14 guideline for method development, both guidelines represent a fundamental change of direction in method development and validation, e.g. implementation of ATP (analytical target profile). The WHO guidelines on transfer of technology in pharmaceutical manufacturing as well as the new draft ICH guidelines represent the new basis for the transfer of analytical methods.