QbD
Extent of CMA Evaluation Required for Non-Critical Excipients
Chief Pharmacist
In development, especially within a QbD framework, there is frequent debate on whether non-critical excipients need detailed characterization of their ...
Lean Six Sigma and QbD
Chief Pharmacist
Quality by Design (QbD) is a science- and risk-based approach outlined in ICH Q8, Q9, and Q10. It emphasizes that ...
Quality by Design (QbD)
Chief Pharmacist
Quality by Design (QbD) is a systematic approach to pharmaceutical development and manufacturing that emphasizes designing quality into a product ...