20 April 2022

ICH Harmonized Guidelines Q14 and Q2(R2)

ICH Harmonized Guidelines Q14 and Q2(R2) (Analytical procedure development – Validation of analytical procedures) published for consultation

The ICH Q2(R2)/Q14 Expert Working Group (EWG) developed a new ICH Quality Guideline, ICH Q14, on Analytical procedure development, and revision of the ICH Quality Guideline, ICH Q2(R1) Validation of analytical procedures. The intention of the EWG group was to prepare/revise guidelines to complement the existing ICH Q8 to Q12 guidelines, as well as the on-going ICH Q13 guideline for Continuous Manufacturing. After an extended processing time, the two documents on ICH Q14 and ICH Q2(R2) were published on the 24th of March 2022 for consultation by the ICH regulatory members. The goal is to finalize by Step 4 by May 2023. Together, ICH Q14 and ICH Q2(R2) describe the development and validation activities proposed during the life cycle of an analytical method to assess the quality of medicinal products and medical devices.

ICH Q14 Analytical procedure development addresses the scientific basis for the development, change management, and submission requirements of analytical methods for a minimal as well as an extended approach. New Analytical procedure development guideline (ICH Q14) is relevant for the sections S4, P4 and P5 of the CTD and will complement with Q8(R2) and Q11. Using the enhanced approach for analytical procedures can contribute to resource-efficient drug development and post-approval CMC changes.

ICH Q2(R2) Validation of analytical procedures provides information and specifications for establishing, submitting, and maintaining evidence that an analytical method is fit for purpose (assuring drug product quality). The revised Validation of analytical procedure guideline (ICH Q2) will be relevant for the sections S4, P4 and P5 of the CTD with emphasis on systematic Analytical Development. The previous harmonised guideline Q2(R1) has been in force in its current form since 2005. At that time, it combined the two guidelines Q2A, which contained analytical methods for required validation parameters, and Q2B, the methodology guideline.

In summary, ICH Q14 and ICH Q2(R2) represent the harmonised scientific and technical principles for analytical methods throughout the lifecycle of analytical methods. ICH Q14, through the principles described, is intended to improve communication between industry and regulatory authorities and achieve more efficient, science-based, and risk-based approval, as well as to facilitate post-approval change management of analytical methods.

The revised form of ICH Q2(R2) continues to provide the general framework for validation of analytical methods, now expanded to include new technologies (e.g., for biological products or multivariate analytical methods).