Background
A new Pharmacy Manufacturing Unit was being established within a UK hospital, requiring full cleanroom installation, equipment commissioning, and validation. The project aimed to ensure GMP compliance for aseptic manufacturing in a healthcare environment.

Challenge
The project demanded the integration of multiple cleanroom utilities and critical systems, alongside complex equipment qualification. Coordination was required across multiple vendors and contractors to ensure timely delivery and regulatory readiness.

Approach

• Led project management and planning for cleanroom installations, equipment commissioning, and validation activities.
• Authored and executed validation protocols for:
  • HVAC and cleanroom environments
  • Compressed air systems
  • Temperature-controlled storage areas
  • WFI, CIP, and automated washing machines
• Reviewed and approved vendor validation protocols, both pre- and post-execution.
• Oversaw validation of critical equipment, including depyrogenation ovens, autoclaves, and aseptic filling machines.
• Performed GAMP assessments for new equipment.
• Established a site maintenance and calibration scheduling system to support long-term operational compliance.

Outcome

• Successful validation and commissioning of all cleanrooms, utilities, and process equipment.
• Delivery of a fully compliant Pharmacy Manufacturing Unit within a hospital setting.

Key Takeaway
Effective project management, combined with rigorous validation of utilities and critical systems, enabled
the delivery of a compliant manufacturing unit that enhanced the hospital’s ability to produce medicines
in-house.