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1
Quality-by-design in pharmaceutical
development
Jelena Djuris, Svetlana Ibric, and Zorica Djuric,
Department of Pharmaceutical Technology
and Cosmetology, Faculty of Pharmacy,
University of Belgrade
Abstract:
This fi rst chapter introduces the concept of quality-by-
design (QbD) and its role in pharmaceutical product development.
QbD assures the quality of a pharmaceutical product through
scientifi c development and risk management tools, and will
eventually enable real-time release, regardless of the formulation
type. Several guidelines on pharmaceutical development, quality
risk management, and pharmaceutical quality systems are presented
that are applicable throughout the product lifecycle. Design space
appointment and control strategies for risk management are
introduced. The meaning of the QbD concept is presented from
both regulatory and manufacturers' points of view. Several
illustrative examples are provided to facilitate the understanding of
the QbD concept and ease of its application.
Key words:
quality-by-design (QbD), design space, risk management
tools, control strategies.
1.1 Introduction
The pharmaceutical industry is one of the most strictly regulated and its
products are of excellent quality. However, there are issues suggesting
