Abstract

COMPREHENSIVE ASSESSMENT AND EVALUATION OF "ENHANCING PRODUCT QUALITY AND PROCESS EFFICIENCY THROUGH QUALITY BY DESIGN"

Sayan Mahapatra* and B. Babu

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Abstract

Quality By Design (QbD), a strategic strategy that attempts to improve product processes and quality across several industries, has become quite popular. Scientific concepts, risk management, and quality control are all part of this well-organized framework for the whole product lifecycle. Manufacturers may produce products that are secure, efficient, and dependable by employing QbD to concentrate on the critical factors that affect product quality. This article meticulously examines and analyses the adoption of QbD, along with its advantages, difficulties, and potential outcomes. At every stage of the product lifecycle, a methodical approach known as Quality by Design (QbD) includes risk management, with an emphasis on its benefits, challenges, and potential. The approach for evaluating the influence and adoption of the principles makes use of survey data and experimental findings. A methodical Design of Experiment (DoE) approach is used to extensively assess the influence of various process factors on the acknowledged key quality attributes (CQAs) of the finished tablet. A case study is also included to demonstrate the usefulness of the recommended technique. Results and Advantages at XYZ Biopharma, batch failure and product variability were significantly reduced.

Keywords: Key process parameters, Process analytical technology, Design space, Failure mode, and effect analysis.