QbD Considerations for Analytical Development

Abstract The concept of quality by design (QbD) applied to analytical method development is known now as analytical quality by design (AQbD). It permits the analytical method for movement within method operable design region (MODR). Unlike current methods, analytical method developed using AQbD approach reduces the number of out-of-trend (OOT) results and out-of-specification (OOS) results due to the robustness of the method within the region. It is a current trend among pharmaceutical industry to implement AQbD in method development process as a part of risk management, pharmaceutical development, and pharmaceutical quality system (ICH Q10). Owing to the lack explanatory reviews, this paper has been communicated to discuss different views of analytical scientists about implementation of AQbD in pharmaceutical quality system and also to correlate with product QbD and pharmaceutical analytical technology (PAT).