Quality By Design

A manufacturing plant or process can be considered to be well managed when:

  • All critical sources of variability are identified, explained and controlled.
  • Product quality attributes can be accurately and reliably predicted for a variety of settings within a predefined Design Space for Manufacturing.

At the beginning of this century the FDA recognised that the Pharmaceutical sector needed to learn from other high-tech industries and modernise itself. In 2002 they announced a significant new initiative, Pharmaceutical Current Good Manufacturing Practices (CGMPs) for the 21st Century. In 2008 this was extended to Biotechnology.

Design Space Management

We are helping our clients develop new business processes and methodologies that support Design Space Management and move away from the traditional 3 batch inspection and check driven focus of the past.

We have added value to this process because of our expertise in the following areas:

  • Quality by Design
  • Generic Design Science and Complex Problem Solving
  • Systems Engineering
  • Risk Based Management