ICH Q14 Guideline on Analytical Procedure Development

Introduction:

The ICH Q14 Draft Guideline on Analytical Procedure Development, endorsed on March 24, 2022, outlines a science and risk-based framework for developing and maintaining analytical procedures essential for evaluating the quality of drug substances and products. This document is currently under public consultation as part of the ICH process.

Key Highlights:
  • Objective: The guideline aims to provide systematic approaches for analytical procedure development, integrating principles from ICH Q8 (Pharmaceutical Development) and ICH Q9 (Quality Risk Management) to ensure procedures are fit for their intended purpose.
  • Scope: It applies to new or revised analytical procedures used in the release and stability testing of commercial drug substances and products, including both chemical and biological/biotechnological entities. The guideline emphasizes a risk-based approach to lifecycle management.
  • Analytical Target Profile (ATP): The ATP is a critical component that defines the intended purpose of the analytical procedure, detailing the product attributes to be measured and relevant performance characteristics. This profile guides the selection of appropriate analytical technologies.
Development Approaches:
  • Minimal Approach: Involves essential elements such as identifying required attributes, selecting suitable technologies, and conducting performance evaluations.
  • Enhanced Approach: Encourages a deeper understanding through risk assessments, multivariate experiments, and comprehensive control strategies, leading to more robust procedures and improved lifecycle management.
  • Lifecycle Management: The guideline discusses the importance of continual improvement and change management in analytical procedures, promoting flexibility in regulatory approaches based on a thorough understanding of analytical processes.
Conclusion:

This guideline is intended to complement existing frameworks like ICH Q2 (Validation of Analytical Procedures) and provides a structured pathway for regulatory submissions in the Common Technical Document (CTD) format. The insights gained from applying these approaches can enhance assurance regarding the performance of analytical procedures while facilitating more efficient regulatory interactions. Overall, ICH Q14 represents a significant advancement in ensuring high-quality pharmaceutical development through rigorous analytical practices.

Reference:

https://database.ich.org/sites/default/files/ICH_Q14_Document_Step2_Guideline_2022_0324.pdf