Recording from Wednesday, January 13, 2021
Do excipient unknowns derail your drug development project? What you don’t know about your excipients might surprise you, and could impact your product. The rational incorporation of excipients into quality-by-design (QbD) can inject robustness into your products and protect them against potential failures.
This webinar reviewed the impact of the new IPEC QbD guide on product development and life-cycle management.
Discussion covered:
- impact of excipient variability on product performance
- critical material attributes
- excipient criticality during development and life-cycle management
- product and process drift
- special cause variation
- bridging the gap between user and maker expectations
Attendees were able to:
- describe QbD and pharmaceutical formulation development concepts to excipient manufacturers and suppliers,
- understand how changes in pharmaceutical formulation practices, due to the introduction of QbD, impact excipient manufacturers and suppliers,
- recognize what excipient users will likely require when applying QbD principles during product development,
- provide feedback to excipient users and regulatory agencies regarding what may or may not be possible when considering the impact of excipient variability in the application of QbD principles during product development