Speaker in this video:
Mr Enoch Daniel, Director, Svan Analytical Instruments
Topic: Beyond the warning letter: How contamination control shapes the future of injectables
Key Highlights:
[1] Contamination control is the biggest regulatory gap today. Most FDA warning letters highlight failures in controlling contamination.
[2] Contamination risk is concentrated in four key areas. First air, indirect contact parts, interventions, and system design define exposure.
[3] The issue is lack of control, not lack of technology. Gaps in systems, design, and execution drive failures. The industry must shift from detection to prevention.
[4] The future is zero contamination by design. Not better control, but eliminating the possibility altogether.