Most Frequently Asked Questions On The Revised EU GMP Annex 1: Volume 8

The 2022 revision of EU GMP Annex 1 has fundamentally shifted the landscape of sterile manufacturing, moving contamination control from a collection of isolated policies to a cohesive, risk-based discipline. Central to this evolution is the Contamination Control Strategy (CCS), a mandatory framework that links premises, equipment, and personnel through continuous quality risk management. To meet these heightened expectations, manufacturers are prioritizing barrier technologies like isolators and RABS to minimize human intervention in critical zones.

Modern compliance requires more than just achieving cleanroom classifications; it demands an integrated approach where primary packaging and supplier qualification are treated as core components of sterility assurance. Leading firms are now harmonizing their operations to these stricter global standards to ensure inspection readiness across multiple regulatory jurisdictions. By treating the CCS as a dynamic decision-making tool rather than a static document, organizations can better protect patient safety while streamlining their path to market.