ECA Analytical Quality Group Feedback to ICH Q2 and Q 14
In March 2022 the European Medicines Agency (EMA) published for public consultation two ICH guidelines: the ICH guideline Q2(R2) on validation of analytical procedures and the ICH guideline Q14 on analytical procedure development, both in step 2b.
ICH Q2(R2) applies to new or revised analytical procedures used for release and stability ICH Q2(R2) Guideline 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 Q8-Q10) 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.
ICH Q14 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.
The ECA Foundation together with its European QP Association provided feedback to the EMA, which was prepared by the Foundation's Analytical Quality Control Group on their behalf. To take a look at the comments provided, please see the following PDF file.
