ONDQA has also successfully implemented a pilot program to determine what information is relevant in applications to demonstrate the key QbD concepts: knowledge of drug substance and drug product ...

QbD methodology is becoming more established in the pharmaceutical sector and is also recognised by the regulatory authorities at a time when the industry is under pressure to deliver efficiencies in ...

The primary goal of the QbD guide is to introduce Quality-by-Design (QbD ... This Guide includes recommendations related to the impact of excipient variability on drug product quality during ...