CRED Getting the CMC Dossier Right 2024

05/09/2024

ICH Q8 and Quality by Design (QbD)

The Organisation for Professionals in Regulatory Affairs

15

QbD Good Scientific Development

• ICH Q8 describes science and risk-based approaches for drug substance, pharmaceutical product and manufacturing process development • Introduced concepts of design space and flexible regulatory approaches to allow fewer post approval changes • Introduced concepts of Quality by Design including some examples and some training materials

Terminology used:

•

• Empirical, minimal or traditional e.g. studying one factor at a time

• Enhanced or systematic e.g. multifactorial studies, statistical approaches, use of models / predictions

The Organisation for Professionals in Regulatory Affairs

16

8