GMP FACILITY DESIGN & READINESS

Overview

We support GMP facility design and readiness aligned with EU Annex 1 and global GMP expectations, ensuring optimal flow, contamination control, and operational efficiency.

Core Deliverables

• Facility layout and zoning strategy

• Personnel and material flow design

• Cleanroom classification and pressure cascade

• Contamination Control Strategy (CCS)

• Environmental monitoring program design

• Utilities qualification strategy

Regulatory Framework

• EU GMP Annex 1 (2022)

• PIC/S PE009

• ISO 14644

Advanced Capabilities

• Greenfield facility planning

• Facility remediation for inspections

• ATMP-specific facility design

Outcome

A compliant, efficient facility designed to minimise risk and support scalable operations.