Quality by Design (QbD) – It may not be “Urgent” but it is almost certainly “Important”

by Rob Oakland

Widespread Lean Manufacturing has been around for a number of years now. Lean in Quality departments is also becoming common, but Lean R&D is still relatively young. The world is however changing quickly. Companies have to contend with the oft-cited patent cliff, cost pressures, and need to accelerate the development process. Furthermore, the regulatory bodies are upping their game through Quality by Design (QbD) – and in the process asking for more from Life Sciences companies.

 

QbD requires a greater understanding of the Critical to Quality (CTQ) attributes of a product and the Critical Process Attributes (CPA) leading to a thoroughly understood ‘Design Space’ that in the longer run at least helps companies reduce deviations, facilitates Continuous Improvement and lower costs.

 

The implementation of QbD has been slow to date. Contrary to the ‘official line’ many companies believe that QbD will extend development times. However, the expectation is that eventually the guidance within ICH Q8,9,10 will become instructive. Companies are therefore deliberating whether to look for first mover advantage, or allow others to make the mistakes from which they will learn.

 

A further risk is that ‘Western’ businesses get their strategy wrong, and companies from Newly Industrialised countries get it right. In fact, statistically this is almost certain to happen. All the more reason for companies, where ever they are based, to look very carefully at the options and not put QbD on the ‘too hard to contemplate while we are so busy’ pile.