The QbD / PAT Conference

Regulatory Background and Objectives

It was only at the turn of the century both industry and regulatory agencies began to fully realise that the ability to meet society's ever increasing healthcare expectations would require a significant step change in the industry's performance. Much has already been put in place to establish the levels of innovation necessary to develop the desired more efficient, agile, flexible pharmaceutical manufacturing sector capable of reliably producing high-quality drug products without extensive regulatory oversight from both regulatory /industry perspectives.

From the outset the key challenges were how to:

• encourage and mange innovation while ensuring high quality
• identify and adopt appropriate technologies which will IMPROVE overall quality
• successfully shift from empirical to science based standards for manufacturing process quality

There is also no doubt that the holistic philosophy embodied in QbD is going to be central to a successful outcome. However the rate of industry progress toward these widely held objectives has been less than might have been expected and, since the publication of critical regulatory manufacturing guidances, we as an industry still fall significantly short of desired manufacturing performance.

The issue is getting there!

Our starting point is empirically based "legacy" products and processes and a ten year plus lead time for new ones built on science based risk assessed principles. The apparent lack of progress is directly related to activities to improve understanding and performance of existing processes, while the lack of apparent consistency of approach is largely down to given company's immediate business needs and life cycle issues.

As a result the theme of this year's conference will have a significant interactive workshop content focusing on the respective roles PAT and QbD will play redressing these impasses.