The ICH has developed a draft of the new ICH Quality Guideline, ICH Q14, Analytical Procedure Development, and revision of ICH Q2(R2), Guideline on Validation of Analytical Procedures, both endorsed on March 22, 2022 for public consultation. The draft, along with other ICH guidance on validation and analytical procedures, can be found here.

The draft revision of Validation of Analytical Procedures includes concepts such as the role of validation in the lifecycle of the analytical procedure and considerations for the validation of multivariate analytical procedures (e.g., near infrared-based analysis and Ramen spectroscopic analysis). There is linkage to ICH Q14 where there is reference to how the results of analytical method development will aid in designing the validation study—as defined within the method validation protocol—and that there are more statistical considerations for the evaluation of the data afforded from validation.

The draft ICH Q14 is a broad guidance covering the development of analytical procedures based upon ICH Q8, Pharmaceutical Development, and ICH Q9, Quality Risk Management Principles.  The draft compliments ICH Q2(R2) and includes concepts on the development of multivariate and real-time release test procedures. There is reference to minimal and enhanced approaches to analytical method development where the enhanced approach results in the development of an analytical control strategy where there is an understanding of which analytical parameters need controlling, which is reflected in the system suitability test and (potentially) sample suitability assessment. 

The draft guidance introduces Established Conditions (ECs) for the analytical procedure (as per ICH Q12) where, with an enhanced approach to analytical method development, there is a greater understanding of those ECs. There is also considerable guidance relating to lifecycle management and post-approval changes of test procedures that (again) sees the benefit of an enhanced approach to analytical method development.

The revised ICH Q2(R2) and new ICH Q14 guidance will hopefully encourage companies to enhance their analytical test procedures and use modern technology rather than outdated, inefficient test procedures. For more information about how these new draft guidelines might impact your organization, contact Lachman Consultants online or via email: LCS@lachmanconsultants.com.

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Paul Mason, Ph.D., is a senior director at Lachman Consultants who has more than 20 years of experience in the pharmaceutical industry. He is a quality control chemist experienced in sterile parenteral, API and solid oral dosage forms. His experience spans finished dosage form, CMOs, and API (intermediates) manufacture support in both a quality control and analytical development setting.