Streamlining Analytical Procedure Development, Validation, and Change Management: ICH Introduces Q2(R2) and Q14 Guidelines

ICH Q2(R2) - Validation of Analytical Procedures

ICH Q2(R2) provides guidance for establishing, submitting, and maintaining evidence that an analytical procedure is suitable for its intended purpose. It offers general principles for performing validation studies and specifies the data that should be included in regulatory submissions. This revision extends the scope of the previous version (ICH Q2[R1]) to include validation principles for advanced analytical procedures such as mass spectrometry and spectroscopic techniques such as NIR, Raman, and NMR and also provides guidance for the application of validation principles to biologics and other advanced therapies. Additionally, the revised guideline introduces new concepts relevant to validation used throughout a procedure's lifecycle, including revalidation, co-validation, platform analytical procedures, and more.

ICH Q14 - Analytical Procedure Development

The new guideline, ICH Q14, focuses on providing science- and risk-based approaches for developing and maintaining analytical procedures used in assessing the quality of drug substances and drug products. It encourages a systematic approach to procedure development, which can be achieved through a minimal (traditional) approach or by incorporating elements of an enhanced approach. The guideline also addresses the development of multivariate analytical procedures, real-time release testing, and the lifecycle management of analytical procedures. Furthermore, it emphasizes the importance of submitting knowledge and information related to the development of analytical procedures to regulatory agencies to demonstrate their appropriateness for the intended purpose and explains how this information may facilitate change management in the analytical procedure lifecycle.

Complementing Each Other

Both ICH Q2(R2) and Q14 are complementary guidelines aiming to enhance regulatory communication between the pharmaceutical industry and regulators, thereby facilitating more efficient and scientifically sound approval processes, as well as post-approval change management of analytical procedures.

Enhancing Adoption: 2024 Initiatives of PQLI Analytical Method Strategy Working Group

ISPE's Analytical Methods Strategy group, a technical team under the Product Quality Lifecycle Implementation (PQLI)® Committee, aims to facilitate the implementation of these guidelines and offer a forum for knowledge sharing among experts from various companies. The working group is co-led by Timothy Graul, Pfizer, and Bryan Castle, Eli Lilly. The 2024 plans include developing training materials, publishing case studies and presentations, hosting webinars, and conducting a survey to assess the status and challenges of guideline implementation. A recording of the team’s recent webinar titled “Future of Analytical Procedures – ICH Q2(R2) & Q14: Development, Validation, & Lifecycle Management” is available to ISPE members.

The survey is open to anyone whose professional role has interactions with analytical procedures. Responses to this survey will help ISPE to identify gaps and pain points, and to develop follow up activities to help the implementation of Q2(R2) and Q14.

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