Pharmaceutical Engineering Services
Our expert team provides engineering and technical compliance support for pharmaceutical facilities, including Greenfield projects, Brownfield upgrades, and Factory Acceptance Test (FAT) audits. Our services ensure that facility design, equipment, and operational layouts comply with global regulatory expectations.
- Brownfield Facility Assessment (Existing Plant)
For existing pharmaceutical facilities (Brownfield projects), our experts perform a detailed review of the current plant layout and engineering systems to identify compliance gaps with regulatory standards.
Our support includes:
- Review of facility layout and building design to ensure compliance with GMP requirements.
- Guidance for renovation, modification, and facility upgrades to improve regulatory compliance.
- Evaluation of pressure zoning layout to maintain proper airflow and contamination control between different areas.
- Review of cleanroom classification and area segregation according to product risk and manufacturing processes.
- Assessment of man and material movement flow to avoid cross-contamination and ensure proper personnel and material pathways.
Based on the assessment, our team provides practical recommendations and engineering guidance for facility improvement and regulatory compliance.
- Greenfield Project Support (New Facility)
For new pharmaceutical facility projects (Greenfield), we provide comprehensive support from the design stage to ensure the plant is built according to regulatory expectations.
Our services include:
- Plant design support based on GMP and regulatory guidelines.
- Review of architectural and engineering layouts if the company has hired an external design consultant.
- Review of pressure zoning layouts to ensure proper airflow control.
- Planning of cleanroom classifications and area segregation based on manufacturing activities.
- Design guidance for personnel and material flow (man and material movement) to maintain product quality and prevent contamination.
This ensures that the facility design supports efficient operations, regulatory compliance, and product quality from the beginning.
- FAT (Factory Acceptance Test) Audit Support
Our team also provides Factory Acceptance Test (FAT) audit support for pharmaceutical manufacturing equipment before installation at the facility.
Our FAT services include:
- Guidance on how to plan and conduct FAT audits according to regulatory expectations.
- Review of equipment design, functionality, and compliance with user requirement specifications (URS).
- Verification of equipment performance, safety features, and control systems.
- Review of documentation such as test protocols, calibration certificates, and technical manuals.
- Identification of any technical or compliance gaps before equipment shipment to the manufacturing site.
This process helps ensure that equipment meets quality, safety, and regulatory standards before installation and qualification.