REVIEW ON HISTORICAL BACKGROUND, KEY ASPECTS, TOOLS, APPLICATIONS AND CHALLENGES ADOPTING IN QUALITY BY DESIGN (QbD).
Namita Tehare* and Madhavi Game
ABSTRACT
Quality by Design is the modern approach for quality of pharmaceuticals. concept of “Quality by Design” (QbD) gaining much attention among pharmaceutical industries for maintaining Quality. The principles of quality have been described by the ICH guidelines: Q8 Pharmaceutical development, Q9 Pharmaceutical quality risk management and Q10 Pharmaceutical quality system. This paper gives idea about the Pharmaceutical Quality by Design (QbD) and describes use of Quality by Design to ensure quality of Pharmaceuticals. It is a scientific approach that helps to build in quality into the product rather than mere testing of the final product. For the implementation of QbD various tools are needed to be used which have been described briefly. Risk assessment approaches, process analytical technology tools and mathematical, statistical and continuous improvement tools are important elements of quality by design, which mainly focus on the identification of critical parameters and defining a design space statistically. The basic principles of these three ICH guidelines with regard to quality of pharmaceutical products have been briefly discussed.
Keywords: Quality by Design (QbD), Target Product Quality Profile (TPQP), Critical Quality Attribute (CQA), Critical Process Parameter (CPP), Quality Risk Management (QRM).
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