Short Abstract

“If the product is the process understanding both is critical for commercial success, a QbD approach is essential for process and product knowledge generation – the foundations that are being used for your product development will determine its success or failure – which do you chose knowledge or ignorance for the path forward”

Over the recent decade it is clear that the expected critical output in terms of regulatory agency expectations of product development is an in depth understanding of both the process and product characteristics. This is a foundational requirement upon which the complete product lifecycle is based. This encompasses the principles of Quality by Design (QbD), the heart of which is the idea that Quality, safety, and efficacy are designed or built into the product and that Quality cannot be adequately assured merely by in-process and finished-product inspection or testing. These are the fundamental concepts and once understood and accepted the QbD approach can become an integrated component of the overall process development effort. The process is logical and the underling concepts rational and yet adoption by industry is not without some resistance to change. Often the long term benefits are not well understood and shorter to mid-term business objectives become the key drivers, speed to market is the critical path. Which is a valid objective given the cost of product development and the need to return the investment? However consider the better investment of staying the complete course of the product lifecycle and not suffering a premature ending due to commercial manufacturing failures or out of control costs.

Still QbD is often viewed as a “means to an end” perhaps facilitating a speedier review by the regulatory agencies. Then the question might be is this worth the effort is the potentially longer process development times and higher cost offset by any strategic business and commercial benefit. Well the answer really is what worth knowledge, knowledge of process and product are invaluable in terms of firstly achieving approval to market the product and then keeping the product supplied to the market. This is not just a regulatory nice to have element it is the foundation upon which the whole product commercialisation can be built.