Module 3 2019

The Future AQbD?

• Science and risk based approach • Development of analytical methodologies in a systematic manner against pre-defined criteria • Gain deeper understanding of measurement systems • More robust and efficient process and product control strategies. • Improve reliability of the method by understanding, reducing and controlling sources of variability • Provide greater assurance that quality attributes of the drug substance, drug product or in-process materials can be reliably and reproducibly assessed. • Facilitates continuous improvement of methods throughout product lifecycle. • Provide opportunities for regulatory flexibility

The Organisation for Professionals in Regulatory Affairs