Background
A newly constructed pharmaceutical distribution centre in Thailand required full commissioning and validation of storage areas and critical utilities to ensure compliance with GMP and regulatory requirements. The facility included multiple temperature-controlled storage zones for medicines and vaccines.

Challenge
The project involved comprehensive temperature mapping of all storage areas, ensuring environmental conditions met product-specific requirements. Additionally, the main HVAC system needed IQ and OQ validation to guarantee consistent climate control across the facility.

Approach

• Planned and executed full temperature mapping studies for all storage areas, covering ambient, refrigerated, and frozen zones.
• Developed and executed IQ and OQ protocols for each storage area, confirming operational performance and regulatory compliance.
• Led the IQ and OQ validation of the main HVAC system, ensuring temperature, humidity, and air-flow met specifications throughout the facility.
• Coordinated with internal stakeholders and vendors to ensure smooth installation, commissioning,
  and testing.
• Provided comprehensive documentation for regulatory audit readiness.

Outcome

• Successfully completed temperature mapping for all storage zones, confirming compliance with GMP requirements.
• Fully validated HVAC system, providing consistent environmental control throughout the distribution centre.
• Delivered a fully operational, compliant facility ready for regulatory inspection and pharmaceutical product storage.

Key Takeaway
Thorough temperature mapping and utility validation, combined with structured IQ/OQ execution, ensured
the new distribution centre met regulatory requirements and maintained product integrity across all storage conditions.