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EU GMP Annex 1 - Comprehensive Renovation Project

The client is transferring production of their anti-cancer drug from overseas to China. To support capacity growth and meet upgraded requirements, the existing cleanroom is being renovated and equipped with new filling machines. The project complies strictly with EU GMP Annex 1 to ensure high cleanliness, product quality, and safety.

AUSTAR Solution

• Filling Zone Upgrade: Reconstructed the LAF system (including extended LAF), integrated PLC control and LED lighting, and optimized airflow. • Layout Optimization: Implemented Grade C/D zoning for material distribution and buffer rooms; upgraded enclosures and ductwork ceilings in the bottle washing room. • Enhanced Visibility: Added observation windows in the preparation room for improved process monitoring. • Full Lifecycle Validation: Conducted DQ/RA/SAT/IQ/OT to ensure compliance with GMP requirements.

Highlights

Stable high‑grade airflow in filling areas meets production needs and supports the new layout.

Dual compliance with 21 CFR Part 11 and EU GMP Annexes 1/11.

Optimized cleanroom structure enables seamless equipment integration and higher productivity.

AUSTAR Value & Client Benefits

• Stable Cleanliness: Achieved consistent high-grade airflow in critical filling areas, meeting production needs and supporting the new layout. • Full Compliance: Satisfied 21CFR Part 11 for electronic records; established a compliant "D→C→C" flow in line with EU GMP Annex 1. • Higher Efficiency: Enabled visual management in the preparation room; optimized bottle washing room structure ensures seamless integration with new equipment.
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