We had the pleasure to participate in the Regulatory & Development track in the session “QbD at minimum or full application”
Ms. Beatriz Artalejo, president of AEFI (spanish industry pharmacists association) presented the speakers and facilitated Q&A final part.
Our speech “How to apply QbD in a SMART way” was adressed to explain SMART QbD ™ methodology that we use to support our customers QbD projects.
To some extent, the idea that still persists is that implementing QbD is complex and / or expensive despite the obvious advantages.
SMART QbD™ is a methodology that adapts to the timing and project constraints but providing appropriate tools to optimize the acquisition of the key knowledge about the product/process with the available resources.
The key feature is efficiency in applying QbD tools: risk analysis, design of experiments and project management. Finding the way to re-use the knowledge we get and not inventing the wheel every time is the key.
We shared with assistants some real examples on how to use non-formal DoE previous trials and other previous knowledge to avoid starting from scrach with surprisingly good results.
Risk analysis is another time consuming process that can be adressed to save the time devoted to endless meetings.
Mr. Frédéric Vaurès Technical Manager – Colorcon Iberica explained the new services that excipient supliers offer to ease the QbD efforts of their customers. Critical attributs of functional ingredients can be crucial for manufacturability or even for the product quality.
The session ended with Q&A. Thanks Pharmaprocess!!