Analytical Procedure Development Following ICH Q14: An AQbD Approach

With the adoption of ICH Q14 in November 2023, the landscape of analytical method development has evolved, introducing a more structured and science-driven framework that aligns with the principles of Analytical Quality by Design (AQbD). Explore how ICH Q14 guidance provides clarity on analytical procedure development, an area previously underserved by regulatory standards, and enables both minimal and enhanced approaches to method creation.

At the core of the enhanced approach is the Analytical Target Profile (ATP), which defines method performance criteria upfront, guiding method selection, parameter risk assessment, and design of experiments (DoE).With a comprehensive workflow that incorporates testing, forced degradation studies, and risk-based control strategies early in development, this approach leads to more efficient validation and a reduced regulatory burden later in the product lifecycle. By embracing the AQbD methodology, organizations can achieve more resilient, adaptable, and compliant analytical procedures. Discover how Labcorp's ICH Q14-compliant approach can improve your analytical outcomes.