Organizational Change and Process Analytical Technology and Quality by Design

On Pharmaceutical Manufacturing magazine’s web site, PharmaManufacturing.com is an 8-minute video presentation given by Emerson’s Melissa Herkt. She gave the presentation, Excellence by Design: Melissa Herkt on The Case for PAT and QbD at the May 11-12 2010 FDA-Partnering with Industry conference.

Melissa describes the process of organizational change as it applies to the Process Analytical Technology (PAT) and Quality by Design (QbD) initiatives. She describes how the people in organizations undergoing change typically are early adopters, fast followers, latent majority, or finally CAVE. In the video, you’ll hear the knowing laughs as she defined this acronym: citizens against virtually everything!

Melissa notes that to make the case for change it’s important to follow the money–that is, the cost of manufacturing. 50% of the cost of manufacturing is in the materials. Organizations that apply PAT can improve “right the first time” production and reduce waste. She shared that the cheapest way to add manufacturing capacity is to stop throwing away materials.

Also, this change can repurpose people to focus on optimization efforts or other areas to improve productivity. And applying predictive technologies can help prevent unscheduled downtime and plant asset failures.

I know from my work in social media that change comes through making the business case, having persistence, having patience, and sharing the vision as broadly as possible at every level. For pharmaceutical and biotech manufacturers, to reap the operational improvements with PAT and QbD requires this same focus.

Leave a Reply