What is Quality By Design?

Quality by Design (QbD) isn't just about quality. It is also about ensuring that drug products have the required safety and efficacy through process control using quality risk management and knowledge management. Building reliable, efficient, and robust cost saving methods supports drug development, production, and evaluation to ensure that quality and safety standards are met. Learning of and eliminating quality issues early in the product life cycle will reduce development costs and deliver safer drugs to the market faster.

In manufacturing, where QbD originates, costs of ensuring quality and safety rise exponentially the further along in the life cycle (which includes R&D, scale-up, production, market introduction, etc.) they are discovered. To avoid these costs, and the risks both to the manufacturer and the consumer, QbD aims for complete knowledge of process and product in order to spot and rectify issues early, therefore minimizing costs and mitigating safety risks.

The FDA has begun advocating that the pharmaceutical industry adopt a 'risk-based approach' to the development of new drugs, one that follows the principles of QbD. This approach implies that more complete information and transparency relating to risk assessment should be made available for new drug applications to prevent late stage failures, ensure safety, and speed up the approval process. In the end, novel medicines would come to market faster, with greater safety, and at lower costs to patients.

When QbD principles are applied to pharmaceutical processes throughout product development and manufacturing, an improved collective understanding of each process in turn, produces a better product. For optimal results, QbD must be applied to every aspect of product development and manufacturing, including those applications which do not directly result in a tangible product, but serve as support for other activities.

One such application is the process of chromatographic method development for the evaluation of APIs, impurities, formulation, and stability indicating studies. By refining the method development process using QbD principles, the goal of building a final separation method with desirable quality attributes, such as reliability, robustness, and efficiency, is achievable. Developing quality methods ensures precise and accurate measurements for correct assessments that give rise to quality products.