Does your company have an effective Quality by Design (QbD) program? Have you shown that you can efficiently determine critical process parameters and justify a control strategy using a thorough understanding of both the product and process?
These are the requirements of QbD. Although initiated in pharmaceutics in Q8 Pharmaceutical Development, QbD was originally introduced in a book by Joseph M. Juran titled quite appropriately Quality by Design.
Q10 Pharmaceutical Quality System used Juran’s model to outline three key objectives for pharmaceutical companies:
Consistently deliver products that meet customer requirements
Establish process control
Facilitate continual improvement
Additional guidance documents have attempted to increase understanding of how the requirements of QbD relate to other key components of the pharmaceutical quality system: Annex to Q8, Q9 Risk Management, and the Guidance on Process Validation.
How do you execute QbD while fulfilling the obligations outlined in other guidance documents?
On Tuesday, July 10 (12:00 pm – 1:00 pm EDT), JMP Training will feature a free webinar that demonstrates the QbD methodology and presents how it relates to other guidance documents. Register to participate.