Mrudula Kulkarni | Sep 22, 2025
Mrudula Kulkarni | Sep 22, 2025
Discover how utilities and SUS form the backbone of sterility and CCS in pharma.
Learn how robust CCS practices preserve sterility assurance through outsourcing, tech transfer, and global manufacturing partnerships.
Discover how linking EM with CCIT transforms sterility assurance—bridging environmental control with product integrity.
Discover the top 10 microbiology triggers for FDA 483s and learn preventive measures to ensure regulatory compliance.
Annex 1 introduces new rules for EM and CCS in cleanrooms, demanding continuous, risk-based monitoring and data-driven contamination control.