Lab Manager | Run Your Lab Like a Business

Articles by Zenaida Otero Gephardt, PhD, PE

Quality By Design

by Zenaida Otero Gephardt, PhD, PE
Quality by Design (QbD) refers to the strategies developed and advanced by the US Food and Drug Administration, the International Conference on Harmonisation (ICH), and the United States Pharmacopeia (USP),1-5 based on scientific principles and risk assessment and focused on product and process understanding.