GDP-validated pharma warehouse — UAE
Regional distributor for vaccines, biologics and oncology needed a GDP-compliant facility with redundant cooling, controlled access and full audit trail.
Challenge
- Zero-downtime requirement during summer (45 °C+ ambient).
- Validation timeline tied to Ministry of Health licensing.
- Mixed +2/+8 °C and −20 °C zones in the same building envelope.
ColdMatch solution
- Dual-redundant chillers with N+1 architecture and 24h backup.
- Calibrated mapping, 21 CFR Part 11 monitoring, validated SOPs.
- ColdMatch coordinated WHO/GDP commissioning with the EPC.
How this project was delivered — planning to commissioning
Design-and-build with an independent qualification consultant. Total programme: 22 months, concept to licensed operation.
- 1
Planning & feasibility
Months 1–5- Product portfolio mapped to +2/+8 °C, −20 °C and controlled ambient zones.
- Redundancy strategy defined for 45 °C+ summer ambient, including N+1 chillers and backup power.
- User Requirement Specification (URS) written before supplier engagement.
Milestone: URS and validation master plan approved.
- 2
Permitting & approvals
Months 5–9- Ministry of Health warehouse licensing pathway agreed and documentation scheduled.
- Civil defence, fire and building approvals for the mixed-temperature envelope.
- Controlled-substance storage and access-control requirements built into the design.
Milestone: Licensing pathway locked with regulator milestones in the project plan.
- 3
Procurement & build-out
Months 9–17- Dual-redundant chiller plant, BMS and 24-hour backup installed.
- Segregated +2/+8 °C and −20 °C rooms constructed inside one building envelope.
- 21 CFR Part 11 compliant monitoring system installed with calibrated sensors.
Milestone: Construction complete, systems energised, IQ documentation issued.
- 4
Testing & validation
Months 17–21- IQ / OQ / PQ executed room by room with an independent qualification team.
- Empty and loaded temperature mapping, plus power-failure and door-open excursion studies.
- SOPs, deviation handling and training records completed for GDP inspection.
Milestone: Zero mapping deviations; validation dossier accepted by the regulator.
- 5
Commissioning & handover
Months 21–22- WHO/GDP commissioning walkthrough with the EPC and quality team.
- Alarm escalation, on-call response and calibration schedule activated.
- First licensed product received under full audit trail.
Milestone: Operating licence granted and facility released for distribution.
This project sits under the Build a Pharmaceutical Cold Chain objective. Start from the objective hub to scope capacity, permitting and budget before engaging suppliers.