Pharmaceutical development based on quality by design

Abstract

The main objective of a pharmaceutical industry is to develop a harmonised pharmaceutical quality system applicable across the lifecycle of the product emphasizing an integrated approach to quality risk management and science. The strategic approach for product development is a choice of applicant and he may choose for minimal approach or a more systematic approach, also defined as Quality by Design (QbD). The minimal approach is an empirical development with one variable at a time fixed manufacturing process and focused on reproducibility, so quality is assured by testing and management is a reactive lifecycle, in other words corrective actions. [1] With the development of technology and the pharmaceutical industry emerged a more complete approach, QbD, to ensure the quality, efficacy and safety of drug product. QbD is an approach that aims to ensure the quality of medicines by employing statistical, analytical and risk-management methodology in the design, development and manufacturing of medicines. One of the goals of QbD is to ensure that all sources of variability affecting a process are identified, explained and managed by appropriate measures. This enables the finished medicine to consistently meet its predefined characteristics from the start. QbD centers on the use of multivariate analysis, often in combination with modern processanalytical chemistry methods and knowledge-management tools to enhance the identification and understanding of critical attributes of materials and critical parameters of the manufacturing process adjustable within the design space. This enhanced understanding of product and process is used to build quality into manufacturing and provides the basis for continuous improvement of products and processes. [2] Both approaches are acceptable, but QbD is preferable and provides the basis for flexible regulatory approaches.