EU GMP Annex 1 Volume 5: Taking A Best Practice Approach To Contamination Control 

The revised EU GMP Annex 1 guidelines have made contamination control a paramount concern for pharmaceutical manufacturers. Establishing a robust Contamination Control Strategy (CCS) is a complex undertaking, requiring a holistic approach to managing the web of interconnected manufacturing processes—from raw material controls for components like elastomer vial stoppers to personnel training and facility management.

An optimized contamination control strategy requires more than just a quick fix; it demands an evolutionary approach. A practical, three-step strategy for evolving your manufacturing base involves an initial foundational phase focused on stabilization and standardization, including behavior training for personnel. This is followed by a phase that prioritizes data analytics for building knowledge systems and identifying control weaknesses. The final stage integrates knowledge systems and risk management for continuous improvement toward a goal of zero defects.