ICH Q14 101: Applying AQbD To CMC For Regulatory Success

The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Q14 is a new quality document describing analytical procedure development. The ICH Q14 guideline represents a significant advancement in the field of pharmaceutical quality control by providing comprehensive guidance on analytical procedure development.

Prior to this, the absence of specific ICH directives on analytical method development created ambiguity regarding the information required for regulatory submissions. This ambiguity often hindered the presentation of a robust scientific rationale for methodologies and the justification for post-approval modifications.

ICH Q14 has been issued in draft form at the time of writing this e-book, offering an invaluable framework for ensuring the development and maintenance of scientifically sound and regulatorily compliant analytical procedures.