6th April 2022
ICH guideline Q14 on analytical procedure development - Public Consultation
This guideline applies to new or revised analytical procedures used for release and stability testing of commercial drug substances and products (chemical and biological/biotechnological). The guideline can also be applied to other analytical procedures used as part of the control strategy (ICH Q10, Pharmaceutical Quality System) following a risk-based approach. The scientific principles described in this guideline can be applied in a phase-appropriate manner during clinical development. This guideline may also be applicable to other types of products, with appropriate regulatory authority consultation as needed. Development of pharmacopoeial analytical procedures is out of scope.