A review on: Applications of pharmaceutical quality by design in product development

Kiran Tambe; Smita Bonde

Authors

Kiran Tambe School of Pharmacy and Technology Management, Shirpur Campus, NMIMS University, Shirpur, Maharashtra, India.
Smita Bonde School of Pharmacy and Technology Management, Shirpur Campus, NMIMS University, Shirpur, Maharashtra, India.

Keywords:

Quality by Design (QbD), Elements of QbD, Process, Analytical Technology (PAT), Quality target product profile (QTPP), Design space, Risk assessment Methodology, Analytical Target Profile (ATP)

Abstract

Quality by Design (QbD) is the modern approach for quality of pharmaceuticals. QbD ensures the quality of Pharmaceuticals. In this review, the Quality by Design is described with the help of few applied examples. Important elements, benefits, opportunities and steps involved in Quality by Design for Pharmaceutical products are described in this review. ICH Guidelines are the foundation of Quality by Design. It is based on ICH Guidelines Q8 for pharmaceutical development, Q9 for the quality risk management, Q10 for pharmaceutical quality systems. QbD is applied in the pharmaceutical development and manufacturing of pharmaceuticals, analytical method development. The aim of the pharmaceutical development is to design a quality product and its manufacturing process to consistently deliver the intended performance of the product. Quality cannot be tested into products but quality should be built in by design. It includes the Quality target product profile, critical quality attributes and key aspects of Quality by Design. It also gives comparison between product quality by end product testing and product quality by Quality by Design.