Abstract

QUALITY BY DESIGN APPROACH FOR ANALYTICAL METHOD DEVELOPMENT

Sakshi Sharma* and Dr. Sharad Wakode

ABSTRACT

An application of the Quality by Design (QbD) approach, is to the exemplar of analytical method development, the process commonly referred to as AQbD. The benefits of applying AQbD principle is to identifying and minimizing sources of variability that might lead to poor method robustness and ensuring that the method meets its planned performance requirements throughout the product lifecycle. It allows the analytical method for movement within method operable design region (MODR). The variables which affect the output and subjected to through risk assessment factor are optimized. The final step is to validated and a control strategies. Analytical method developed using AQbD approaches to reduces out‐of‐trend (OOT) and out‐of‐specification (OOS) which results into the robustness of the method within the region Continuous improvement is the key to the success of AQbD. Harmonization of QbD terms and specific guidelines on implementation of the QbD approach in all fields of product development is require to design the path towards embracing this unique and effective approach . Owing to the famine of overviews on this topic, this paper endeavor to explicate the AQbD process and also to correlate with product quality by design and pharmaceutical analytical technology(PAT).

Keywords: QbD, AQbD, Analytical, MODR, Quality by Design.