Application of tools and techniques of quality by design in pharmaceutical process

Abstract

Purpose The purpose of this article is to demonstrate the application of the tools and techniques of Quality by Design (QbD) approach in an Indian pharmaceutical drug product manufacturing company and to understand the challenges, managerial implications and lessons learned while implementing this initiative. Design/methodology/approach This work adopts the Action Research methodology for impurity reduction in a drug product manufacturing company in India by using the tools and techniques of QbD approach. Various QbD tools like Design of experiments, process capability evaluation and control charts were effectively utilized for the study. Findings As a part of QbD implementation in the organization, a specific drug product was identified and the impurity level in the product was studied. Significant variables impacting the impurity were identified and the optimum levels for the significant variables were identified through design of experiments. The solutions were implemented and the impurity levels were reduced significantly. Research limitations/implications Even though the article is based on a single case study related to tools and techniques of QbD in a single organization in India, the identified problem is a generic product quality related issue for any pharmaceutical drug product manufacturing company. Hence the findings of this research are applicable to pharmaceutical drug manufacturing industry in general. Originality/value This article illustrates the systematic usage of various tools and techniques of QbD methodology in a pharmaceutical drug product manufacturing company. The usage of Design of Experiments for process optimization and application of other tools and techniques are ready references for the practitioners and novice users in the field.

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