19 Dec The ICH Q2(R2) and new Q14 Guidelines reached Step 4 and were adopted by the ICH Assembly Regulatory Members
The ICH Q2(R2) “Revised Guideline on Validation of Analytical Procedures” and the new ICH Q14 Guideline on “Analytical Procedure Development” were adopted by the ICH Assembly Regulatory Members during the Meeting on 31 October and 01 November 2023.
The proposed ICH Q2(R2) and ICH Q14 guidelines are intended to complement the ICH guidelines Q8 to Q12, as well as the ICH Q13 guideline for continuous manufacturing.
ICH Q2(R2) presents elements included as part of registration applications. It provides guidance on selection and evaluation of the various validation tests for analytical procedures.
The comprehensive revision of the ICHQ2(R1) guideline was made to include more recent application of analytical procedures and to align the content with Q14 guideline.
The validation of an analytical method used for the assessment of the quality of drug substances and drug products, throughout entire life cycle was considered, describing considerations for the development of multivariate analytical procedures and for real time release testing (RTRT) or near infrared spectroscopy (NIR), which were not previously considered in the ICH Q2 guideline but are already used in practice.
Two annexes on the selection of validation tests based on the analytical method and with illustrative examples for analytical techniques have been added.
ICH Q14 guideline aims to harmonise scientific approaches to analytical method development and describes the principles for their process description, change management and submission requirements for a minimal and extended approach. Applicants should be supported in not submitting analytical validation results in isolation but presenting them in the context of a performance evaluation against corresponding analytical development results.
The new guideline is intended to improve communication between industry and regulators and achieve a more efficient, science-based, and risk-based approval. This in turn should facilitate post-approval change management of analytical procedures.