Services

At Marlhill Engineering, we provide independent, third-party Commissioning and Qualification (C&Q) services tailored to the pharmaceutical industry. Our team brings deep expertise and regulatory insight across a wide range of systems and facility types.

HVAC Systems

Independent C&Q of cleanroom and critical environment HVAC systems, ensuring compliance with GMP and ISO cleanroom standards.

Utility Systems

Qualification of critical utilities including purified water (PW), water for injection (WFI), clean steam, compressed air, and nitrogen systems.

Process Systems

C&Q support for API production equipment, bulk drug manufacturing systems, and fill-finish process lines.

Automation & Control Systems

Verification and validation of PLCs, SCADA, BMS, EMS, and DCS platforms in compliance with GAMP 5 and data integrity requirements.

Industry Expertise

We have significant experience delivering C&Q services across:
API Manufacturing Facilities,
Bulk Drug Substance Plants,
Fill-Finish and Sterile Manufacturing Operation.

Additional Services

Project Management,
C&Q documentation development,
Project lifecycle support from design review through handover,
Regulatory audit preparation and remediation,
Risk-based qualification approach aligned with ASTM E2500.