SFDA & MOH Temperature and Humidity Mapping: ISO 17025 GCC Validation

Why Temperature & Humidity Mapping Matters

In today’s regulated pharmaceutical, healthcare, and food industries across the GCC, temperature monitoring alone is no longer enough. Regulatory authorities like the Saudi Food and Drug Authority (SFDA) and the Oman Ministry of Health (MOH) now require Temperature and Humidity (T&H) Mapping Validation for all storage and transport environments.

As an ISO 17025 accredited calibration and validation provider, Westcal supports organizations in achieving SFDA temperature and humidity mapping and MOH cold chain validation with complete, audit-ready documentation, ensuring that humidity never becomes your compliance weak point.

SFDA Temperature & Humidity Mapping Requirements (Saudi Arabia)

The SFDA enforces one of the most stringent environmental validation frameworks in the GCC. Non-compliance, particularly in pharmaceutical storage and logistics, can lead to shipment rejections, license suspensions, or product loss.

Key Technical Requirements

• Humidity Accuracy: Instruments must measure humidity with an accuracy of ±4% RH or better.

• Logging Duration: Data loggers must continuously record temperature and humidity for at least 180 days.

• Application Scope: T&H mapping is mandatory for warehouses, cold rooms, refrigerated trucks, and containers.

Digital Reporting and Traceability

The SFDA digital transformation initiative mandates an electronic linkage between internal monitoring systems and official platforms such as Wasl. All sensors and data loggers must be NIST-traceable and ISO 17025 calibrated, ensuring precision and traceability during audits.

Oman MOH, GCC GSDP & International Guidelines

The Oman Ministry of Health (MOH) cold chain protocols primarily govern vaccine storage, while GCC Good Storage and Distribution Practice (GSDP) standards extend environmental controls to all temperature-sensitive products.

When is Humidity Mapping Required?

According to WHO and PIC/S GDP guidelines, humidity mapping must be conducted in any area where the product manufacturer specifies a relative humidity (RH) range.

The Westcal Temperature & Humidity Mapping Protocol

Westcal’s ISO 17025 accredited process provides an end-to-end scientific assessment of your facility’s environmental stability.

• 3D Sensor Grid Layout: Strategic placement across all corners, levels, and HVAC points for precise data capture.

• Study Duration: Typically 7–10 days, covering full operational cycles to validate environmental consistency for the required 180-day monitoring period.

• Calibration & Accuracy: All data loggers are ISO 17025 certified and NIST-traceable.

• Detailed Reporting: Reports include hot/cold spot analysis, 3D data visualization, and CAPA (Corrective Action Preventive Action) recommendations.

All reports are SFDA audit-ready, MOH Oman approved, and aligned with GCC GDP standards.

Why Choose Westcal for SFDA & MOH Compliance?

• ISO 17025 Accreditation: Trusted, globally recognized calibration and validation.
• Regional Expertise: Proven success across Riyadh, Jeddah, Dammam, Muscat, and Jebel Ali.
• Audit-Ready Deliverables: Comprehensive CAPA reports, calibration certificates, and Wasl system integration.
• Regulatory Assistance: Expert support with SFDA and MOH documentation requirements.

Westcal empowers your organization to maintain complete regulatory compliance, reduce audit risks, and ensure the integrity of temperature-sensitive operations across the GCC.

Partner with Westcal for Certified GCC Compliance

Ensure your storage and logistics facilities meet every SFDA and MOH temperature & humidity validation standard with confidence. Westcal’s ISO 17025 accredited calibration delivers precision, credibility, and complete peace of mind during audits — making compliance a seamless part of your quality system.