The ICH Q2 Guideline on the validation of analytical procedures applies to the analytical procedures used for release and stability testing of commercial drug substances and products. ICH Q2 has been in existence since 1993, with ICH Q2(R1) coming into effect in November 2005. A complete revision of the R1 guideline was initiated in March 2022, and completed when ICH Q2 (R2) was released in December 2023.
The ICH Q2 revision to R2 was necessary to consider technical progress in analytical testing, due in part to the growth of biotechnology products over the last two decades, and to align Q2 with the new ICH Q14 Guideline on analytical procedure development.
ICH Q14 outlines a science and risk-based approach to the development and lifecycle management of analytical procedures. It states that a minimal approach to analytical method development is still acceptable, however an enhanced approach is preferable. With a minimal approach, analytical procedure development is effectively complete before the method undergoes validation. The enhanced approach provides a systematic way of developing and refining knowledge of an analytical procedure over its lifecycle, it provides better assurance of the performance of the procedure, it can serve as a basis for the analytical control strategy, and it can provide an opportunity for more efficient regulatory approaches to post-approval changes.
ICH Q2(R2) will benefit industry and regulators as it provides significantly more detail regarding the expectations for analytical procedure validation studies than ICH Q2(R1). For the first time, the guideline includes illustrative examples of analytical procedures for testing of products, as well as appropriate validation criteria and validation testing methodology for each. For biological products, this includes acceptable approaches for validation of biological assays (binding assays, e.g., ELISA, and cell-based assays), impurities testing by qPCR, and LC/MS analysis.
As the ICH Q2(R2) and ICH Q14 guidelines are closely related, a comprehensive set of training materials will be delivered by the ICH Q2(R2)/Q14 Implementation Working Group (IWG) to ensure the proper interpretation and aligned understanding of the new guidelines by industry and regulators. The target date for finalisation of the training materials by the IWG is March 2025.
