Abstract
This paper explores the current analytical method validation practices, mainly derived from the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) Q2(R1) guidelines (2005) and presents a strategy for adopting the latest guidelines for analytical chemistry in the pharmaceutical industry (ICH Q14/Q2(R2), USP ⟨1220⟩). These documents emphasize a lifecycle approach to method development, qualification, and validation, aligning with the holistic, risk-based control strategy central to future submission dossier structures. Key elements of the enhanced approach described in ICH Q14, including Analytical Target Profile (ATP), Knowledge Management, Analytical Risk Assessment, and Performance Monitoring, are discussed and integrated into a clear Analytical Quality by Design (AQbD) framework for analytical procedure development and lifecycle management. When leveraging a risk-based approach, it is necessary to balance between the benefits of post-approval flexibility and the resource investments required for implementation of the additional elements. Over time, the proposed strategy should streamline analytical development, result in well-understood analytical methods, and simplify lifecycle management.
Published Version
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