Pseudo-Empirical Modeling Essential To True Quality By Design

By Adrian Possumato, Global Director, Healthcare Packaging, Multisorb Technologies

Quality by Design (QbD) is a systematic approach of reaching quality standards by looking at the entire developmental system and product life cycle. It brings to the forefront some of the essential, yet often overlooked elements of quality assurance throughout the stability profile of a drug product.

For example, maintaining the stability of a drug product formulation requires controlling the relative humidity and/or oxygen concentration of a pharmaceutical package's headspace and drug product's free moisture level over time. But this critical step in the process is seldom taken into account until a problem arises late in the development or even approval process. QbD principles help avoid such problems by providing a framework for controlled development, manufacture, and commercialization of pharmaceuticals.