Quality by Design (QbD) for Herbal Drug Products: Challenges, Opportunities and a Risk-Based Development Framework

Shahana U; Adithya Murali C K; Haritha Ramadas

Quality by Design (QbD) for Herbal Drug Products: Challenges, Opportunities and a Risk-Based Development Framework

Author(s)	Ms. Shahana U, Ms. Adithya Murali C K, Ms. Haritha Ramadas
Country	India
Abstract	Quality by Design (QbD) is a science- and risk-based pharmaceutical quality framework that shifts the paradigm from post-hoc testing of final products to designing quality into a product and process. Herbal drug products present unique challenges due to the complex nature of botanical materials, which may involve multiple variables such as taxonomy, chemotype, geographical origin, agroclimatic conditions, harvesting practices, processing, storage, and extraction procedures. All of these factors could contribute to undesired product quality variability affecting the safety, efficacy, stability, and performance of the final dosage forms. This article aims to discuss how QbD can be applied to herbal drug products by taking into account botanical authenticity, selection of quality markers, multivariate chemical profiling, quality risk management, design of experiments (DoE), analytical quality by design (AQbD), and process analytical technology (PAT) as well as lifecycle pharmaceutical quality management. Particular emphasis is placed on the importance of considering material-related aspects as upstream quality attributes by implementing a material-inclusive design space. The risk-based framework is proposed that starts with defining the quality target product profile (QTPP) and critical quality attributes (CQA) and linking them with critical material attributes (CMA) and critical process parameters (CPP). This is achieved through quality risk management, design of experiments, analytical development, and control strategy. The article also highlights emerging approaches such as DNA-based authentication, spectroscopy, chemometrics, metabolomics, machine learning, and digital tools as part of the quality management system rather than standalone solutions. Altogether, this framework is intended to enable consistent product quality, advanced process understanding, analytical control, and regulatory compliance by ensuring that inherent variability of botanical materials is characterized, understood, and appropriately controlled within predefined ranges.
Keywords	Quality by Design, herbal medicines, botanical drugs, quality risk management, design of experiments, quality markers, analytical Quality by Design, chemometrics, process analytical technology, lifecycle management
Field	Medical / Pharmacy
Published In	Volume 8, Issue 5, September-October 2026
Published On	2026-09-17

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Quality by Design (QbD) for Herbal Drug Products: Challenges, Opportunities and a Risk-Based Development Framework

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