Pharma Focus Asia

Analytical Quality by Design: A Tool for Regulatory Flexibility and Robust Analytics

Ramalingam Peraman, Kalva Bhadraya, Yiragamreddy Padmanabha Reddy


Very recently, Food and Drug Administration (FDA) has approved a few new drug applications (NDA) with regulatory flexibility for quality by design (QbD) based analytical approach. The concept of QbD applied to analytical method development is known now as AQbD (analytical quality by design). It allows the analytical method for movement within method operable design region (MODR). Unlike current methods, analytical method developed using analytical quality by design (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 analytical quality by design (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 quality by design and pharmaceutical analytical technology (PAT).

Citation: Ramalingam Peraman, Kalva Bhadraya, and Yiragamreddy Padmanabha Reddy, “Analytical Quality by Design: A Tool for Regulatory Flexibility and Robust Analytics,” International Journal of Analytical Chemistry, vol. 2015, Article ID 868727, 9 pages, 2015. doi:10.1155/2015/868727

Received: 11 September 2014; Revised: 11 January 2015; Accepted: 13 January 2015

Academic Editor: Roland Marini

Copyright: © 2015 Ramalingam Peraman et al. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.


Analytical methods for existing drugs have to be periodically reevaluated to address any gaps or any improvement in method performance, risk factors using AQbD. Range of robustness for the method needs to be proven by verification and scientific understanding in order to avoid method failure in method transfer and also to reduce OOS and OOT.

Conflict of Interests

The authors declare that there is no conflict of interests regarding the publication of this paper.

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