Abstract

IMPLEMENTATION OF QBD TO ANALYTICAL METHOD DEVELOPMENT PROCESSES

Nayana Nanasaheb Narawade*, Jyotsna Balasaheb Jadhav, and Reshmavati Dhanrag Patil

Abstract

Recent pharmaceutical regulatory documents have stressed the critical importance of applying quality by design (QbD) principles for in-depth process understanding to ensure that product quality is built in by design. QbD tools, for example risk assessment and design of experiments, enable enhanced quality to be integrated into the analytical method, enabling earlier understanding and identification of variables affecting method performance. The different ways several authors have treated single QbD steps of method development are reviewed and compared. Since the adoption of the ICH Q8 document concerning the development of pharmaceutical processes following a Quality by Design (QbD) approach, there have been many discussions on the opportunity for analytical method developments to follow a similar approach. As per the FDA, implementing the Quality by Design (QbD) approach for the analysis of commercially available mixtures is hypothesized to enhance the pharmaceutical industry via facilitating the process of analytical method development and approval.

Keywords: QbD, Design of Experiment, Design Space, Process Analytical Technology (PAT), Analytical Target Profile (ATP).