Quality by Design
Discoverant Enables Quality by Design (QbD)
Beginning in 2001, and followed in 2004 by the publication of its "Guidance for Industry: PAT - A Framework for Innovative Pharmaceutical Development, Manufacturing and Quality Assurance," the FDA challenged the industry to achieve a level of process understanding that allows control process variability and assurance of product quality in "real-time" while the batch is being manufactured (RTQA). An increased emphasis has been placed on continuous quality verification which requires that product quality be designed into the process. "Quality by Design" (QbD) requires pharmaceutical manufacturers to make larger investments earlier in the product life cycle, i.e. during process development.
When achieved, Quality by Design means that all critical sources of process variability have been identified, measured and understood so that they can be controlled by the manufacturing process itself.
Aegis' Discoverant helps life science manufacturers realize the value of QbD by helping to:
- Reduce batch failure rates, reduce final product testing and lower batch release costs
- Lower operating costs (fewer failures and deviation investigations)
- Increase predictability of manufacturing output and quality
- Reduce raw material, WIP and finished product inventory costs
- Faster tech transfer between development and manufacturing