ARCHIVES
VOL. 11, ISSUE 1 (2026)
A review article on Quality by Design (QBD): Advanced regulatory framework, industrial implementation, and emerging applications in medicinal plant research
Authors
K Shruthi, G Pranay Teja, Dr. Ramya Sree
Abstract
Quality by Design (QbD) represents a paradigm shift from empirical,
end-product testing toward a science- and risk-based framework that
systematically embeds quality into product and process development.
Initially institutionalized within pharmaceutical regulatory frameworks through
ICH Q8 (R2), Q9, and Q10 guidelines, QbD has evolved into a comprehensive
lifecycle management strategy encompassing product development, process
optimization, control strategy establishment, and continuous improvement. This
review critically evaluates the conceptual evolution, regulatory foundations,
mechanistic components, and industrial applications of QbD. Particular emphasis
is placed on its expanding role in herbal drug development and medicinal plant
standardization, where intrinsic biological variability poses significant
quality challenges. The integration of multivariate statistical tools, design
of experiments (DoE), process analytical technology (PAT), and chemometric
profiling has enabled the translation of QbD principles into
phytopharmaceutical research. Despite demonstrable advantages—including enhanced
regulatory flexibility, reduced batch failures, and improved process robustness—barriers
such as data complexity, high implementation cost, and lack of global
harmonization remain. Emerging digital technologies including artificial
intelligence, digital twins, and blockchain systems are poised to augment
QbD-based predictive control models. This manuscript provides a critical
synthesis of current evidence and identifies future research directions
necessary for strengthening QbD implementation across synthetic and plant-
based medicinal products.
Pages:146-149
How to cite this article:
K Shruthi, G Pranay Teja, Dr. Ramya Sree "A review article on Quality by Design (QBD): Advanced regulatory framework, industrial implementation, and emerging applications in medicinal plant research". International Journal of Research in Pharmacy and
Pharmaceutical Sciences, Vol 11, Issue 1, 2026, Pages 146-149
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