Continuous Improvement

The following articles and materials explore best practices in pharmaceutical continuous improvement, and aim to assist drug development and manufacturing professionals in their ongoing pursuit of Quality by Design.

How Quality by Design Is Changing Drug Development

Without QbD thinking, sponsors' attempts to address FDA "complete response" letters may be doomed.

API Manufacturing: A Road Map for "Green" Chemistry and Processes

Green chemistry, one facet of Quality by Design thinking, is based on simplified processes and process engineering creativity

Embracing Risk

As we move ahead as an industry, transforming our concept of quality to align with the latest FDA and international regulations, we find ourselves in uncharted waters.

Brain Rein

As AstraZeneca and Baxter have discovered, knowledge management technologies can harness a company's collective (and global) intellect

Management of Change: Every Plant for Itself!

In the absence of FDA guidance, each company or facility must develop its own approaches to change management. Fortunately, OSHA offers a model.

The Stability Study: Supporting Product Development and Continuous Improvement of Products

To meet the demands of various international legal requirements and regulations such as Good Manufacturing Practices (GMP), SAP has developed software to support stability studies as part of quality management with the SAP ERP application.

Culture Change Needed to Apply Risk Management Correctly

Karen Ginsbury talks FMEA and more.