EU & PIC/S Annex 1: CCS Shortfalls After 2 Years Of Implementation

Two years into Annex 1 implementation, many Contamination Control Strategies still fall short—missing required elements, lacking true Quality Risk Management alignment, or failing to function as living documents. Yet regulators now view the CCS as a clear indicator of quality maturity and a central focus during GMP inspections and audits.

Examine the three critical stages of CCS development, from gap analysis through lifecycle management, and explore how to connect CCS to robust, less subjective risk assessments aligned with the revised ICH Q9(R1). See how FMECA-based models can strengthen contamination control decisions across sterile manufacturing, ATMPs, early-phase programs, and CDMO operations. Real-world case studies highlight common CCS weaknesses and proven mitigation strategies, followed by an interactive discussion on regulatory and operational challenges.