ICH releases draft guidelines on analytical method development
The International Council for Harmonization (ICH) on Thursday issued two draft guidelines that should make it easier for manufacturers to switch analytical methods for testing medicines postapproval and are aimed to promote more robust analytical processes.The Q14 guideline would harmonize the scientific approaches for analytical procedures development while the Q2(R2) document covers the validation principles for the use of analytical procedures such as near-infrared (NIR)-based analysis and Raman spectroscopy, “which often require multivariate statistical analyses.”
ICH announced on 31 March that both guidelines “are intended to complement ICH Q8 to Q12 Guidelines, as well as on-going ICH Q13 for Continuous Manufacturing, with a view to potentially combine both documents into one, for simplification and clarity.” Both guidelines are at Step 2 and available for public consultation.
Industry officials and regulators announced over the summer that both guidelines would be forthcoming. (RELATED: Upcoming ICH guidelines should ease post-approval changes for analytical methods, Regulatory Focus, 14 July 2021).
Officials said that companies are often reluctant to change analytical methods and continue to use outdated and inefficient methods because of the cost involved in applying for and implementing these changes worldwide.
ICH Q14 proposes to harmonize analytical procedure development
The 64-page ICH Q14 document proposes to harmonize the scientific approaches for analytical procedures development by describing a minimal or an enhanced approach. It also describes the elements on an analytical target profile (ATP) which is incorporated in the enhanced approach.
The ATP is described as “a prospective summary of the performance characteristics describing the intended purpose and the anticipated performance criteria of an analytical measurement.”
The guideline also discusses how to develop multivariate analytical procedures, such as procedures for real-time release testing, and addresses where analytical procedure development information should go in the Common Technical Document (CTD).
An Annex in the guideline provides examples of how analytical procedure performance characteristics can be summarized in an ATP.
ICH Q2 revision proposes validation principles for analytical procedures
ICH said the 38-page ICH Q2(R2) guideline “provides guidance and recommendations on how to derive and evaluate the various validation tests for each analytical procedure,” and is aligned with the Q14 document.
The guidance describes the analytical procedures validation study, and how prior knowledge can be incorporated into the validation study design
The document also addresses how to assess the specificity of an analytical test, as well as how to evaluate a test’s accuracy, precision and robustness. It also contains two annexes; Annex 1 addresses how to select validation test, while Annex 2 provides illustrative examples of analytical techniques.
Both guidelines fill a void
According to an ICH concept paper, both guidelines aim to fill a void in analytical method development toolbox.
Before ICH Q14, there was no ICH guideline on analytical procedure development; applicants had to report analytical validation results alone without presenting any data to support analytical development outcomes.
The lack of such a framework made “regulatory communication ineffective especially when non-conventional (for example, real time release testing) analytical procedures are employed.”
Additionally, the lack of guidance precluded applicants from “an opportunity to present scientific basis for flexible regulatory approaches to post-approval Analytical Procedure changes.”
The paper further notes that ICH Q2(R2) is designed to update the existing Q2(R1) guidance to incorporate the more “recent application of analytical procedures” such as NIR methods and Raman spectroscopy.
ICH Q14
ICH Q2(R2)
