Analytical quality by design (AQbD) in the ICHQ14 guidelines for analytical procedure development

Analytical quality by design (AQbD) is one of the risk-based approach used to develop robust analytical method in compliance with regulatory requirements. The concept of AQbD was recently established in the literature and has proven advantages in the pharma industries. Despite the differential view on AQbD, the International Council for Harmonization (ICH) has released the ICHQ14 document for analytical procedure development. Notably, the enhanced approach of the ICHQ14 document mimics AQbD workflows in analytical procedure development. Among ICHQ14 recommendations, the need for knowledge assessment, multivariate models for proven acceptable range (PARs) as method operable region, sample suitability assessment in robustness, and real-time release testing with product critical quality attribute specifications  as the challenging components for pharmaceutical industries. In addition, the integration of ICHQ14 with other ICH documents like ICH Q6A/6B, ICHQ8, ICHQ9, ICHQ10, ICHQ11, and ICHQ12 are well defined in the document. Thus, the revised ICHQ2 (R2) guideline has defined the validation procedure with integration to ICHQ14 documents.