In Force Checked October 24, 2026
The revised edition, published August 25, 2022, has applied since August 25, 2023; the lyophilizer loading provision followed a year later.
What It Covers
GMP for sterile medicinal products, built around a contamination control strategy and quality risk management, covering facilities, utilities, personnel, equipment, environmental and process monitoring, aseptic processing and sterilization.
Who It Applies To
Manufacturers of sterile medicinal products for the EU market, and by extension PIC/S member inspectorates.
Key Requirements
- A documented contamination control strategy (CCS) across the facility and process.
- Cleanroom grades, qualification, and environmental monitoring designed from risk.
- Aseptic process simulation, personnel qualification, and gowning.
- Sterilizing filter integrity testing, including pre-use post-sterilization testing where applicable.
What an Auditor Asks to See
- The contamination control strategy and how it is reviewed.
- Environmental monitoring trends and the actions on excursions.
- Aseptic process simulation results and interventions.
Where Systems Fall Short
- A CCS written as a document rather than used as a system.
- Environmental monitoring locations chosen by habit rather than risk.
How QES Helps
A contamination control strategy tied to the monitoring data and the deviations it is meant to prevent.
Related Standards
Sources. European Commission — EudraLex Volume 4, EU GMP guidelines (opens in a new tab). Status checked October 24, 2026. This page summarizes EU GMP Annex 1; it does not reproduce or replace it. Buy the standard from its publisher, or read the regulation in its official text, before relying on a detail. Not legal advice.