ABSTRACT
The manufacturing of pharmaceuticals suffers from the problem of drug development in general. Many drug manufacturing processes are characterized by inefficiency, waste, and a slow adoption of modern process control technologies. To implement this evolving science and risk-based regulatory science framework in the pharmaceutical sector, collaborative efforts among the regulated industry, the academia, and the regulatory agencies are needed such that best medical products are available to the public. The Quality-by-Design (QbD) principles and scientific case studies discussed below would provide some examples on how robust process and consistent quality may be achieved by applying Quality QbD principles to capsule formulation and process development. First, the general QbD principles applied to capsule formulation and process development will be introduced. Then, several scientific case studies that illustrate how QbD principles are applied to capsule-filling process control and product quality will be provided. Finally, the current challenges and future outlook on capsule fill QbD will be discussed.
