Quality by Design

RPS Systems has entered into the innovation consortium: Quality by Design in food and pharmaceutical industries funded by the Danish government and the participating parties. This innovation consortium consists of world leading partners from the Danish Pharma and Food industry e.g. Novo Nordisk, Lundbeck, Arla and the scientific branch is represented by Copenhagen University (Life) and GTS institute DELTA – plus several other partners.

The idea is to develop and bring processlinestate-of-the-art research in sensor technology from the science world (e.g. Raman systems)  to the process line and the industry. Combined with  advanced multivariate data analysis this will enable the pharma and food industry to have instant information on its processes and as a consequence increase output homogeneity and minimize waste products which will improve bottom line figures.

What is QbD?

The primary goal of Quality by Design (QbD) is to provide up-to-date/instant information on in/on or at-line processes which makes it possible to consistently generate products of predetermined quality. In so doing, improved quality and efficiency are expected from:

  • reduction of cycle times using on-, in-, or at-line measurements and controls
  • prevention of reject product and waste
  • real time product release
  • increased use of automation
  • facilitation of continuous processing using small-scale equipment, resulting in improved energy and material use and increased capacity

The QbD (or PAT) platform is based on the current FDA belief that quality cannot be tested into products, but should be built-in or by design.