Volume :

3

Issue :

4

Abstract :

Pharmaceutical industry is moving towards quality. Many pharmaceutical companies have used several Quality Management System (QMS) for instance ISO 9001. Design process has one of the most important factors that contributing in pharmaceutical product quality. The pharmaceutical industry is used the concept of Quality by Design (QbD) to apply science-based manufacturing principles for new and existing products to assure quality of the formulation. In a first step, the QbD-methodology is systematically used to establish the critical quality attribute identify potentially critical input factor and these factors to define activities for process characterization. A process DOE was used to evaluate effects of the design factors on manufacturability and final product CQAs, and establish design space to ensure desired CQAs. Critical material and process parameters are linked to the critical quality attributes of the product. Experiments were designed with focus on critical material and process attributes. Quality by design is an essential part of the modern approach to pharmaceutical quality. The purpose of this article is to discuss the use of Quality by Design (QbD) in pharmaceuticals and describe how it can be used to ensure pharmaceutical quality. Process parameters and quality attributes were identified for each unit operation. The design space was established by the combined use of DOE, optimization and multivariate analysis to ensure desired CQAs. Multivariate analysis of all variables from the DOE batches was conducted to study relationships between the variables and to evaluate the impact of material attributes/process parameters on manufacturability and final product CQAs.