Module 3 2019

The Future

• Regulatory Guidelines do change/evolve. • Experimental Design becoming more important / Reporting Criteria changing and using more statistics • Focus on genotoxic impurities • Process Assessment Technology (PAT) • Automation / robotics will play an increasing role in experimentation • Intelligent validation software is beginning to appear • Reporting standards and information gained from the validation exercise should continue to be enhanced • QbD for Analytical Methods (AQbD) gaining increasing traction

The Organisation for Professionals in Regulatory Affairs