Annex 1 in Practice: Building a Contamination Control Strategy That Survives Inspection

Summary

Two years after EU GMP Annex 1 took full effect, inspectors expect a living contamination control strategy rather than a document. This paper reviews common observations and offers a structure for a CCS that sites can maintain.

Key takeaways

1. 01The CCS elements inspectors examine first
2. 02How to link risk assessments, monitoring data and CAPA into one strategy
3. 03A maintenance cadence that keeps the CCS current
4. 04Examples of observations and how sites responded

Written for

• QA heads
• Sterility assurance leads
• Regulatory affairs