IQ/OQ/PQ Validation & WHO PQS Compliance in the GCC

What IQ/OQ/PQ means for cold chain

IQ/OQ/PQ is the standard qualification sequence used across pharma and life sciences to prove that equipment, warehousing and packaging perform as intended:

• **IQ — Installation Qualification**: the unit is installed correctly, per spec and per the manufacturer's requirements
• **OQ — Operational Qualification**: the equipment operates within defined ranges under its expected conditions
• **PQ — Performance Qualification**: the system consistently performs to acceptance criteria in real or simulated use

Why it matters in the GCC

Health authorities across the GCC — including the SFDA in Saudi Arabia and the MOHAP in the UAE — increasingly expect documented qualification for cold chain infrastructure supporting pharmaceutical and vaccine distribution. A clean IQ/OQ/PQ record shortens audits, approvals and customs clearance.

WHO PQS in the Gulf region

WHO PQS (Performance, Quality and Safety) is the WHO's pre-qualification scheme for devices used in the Expanded Programme on Immunisation, including cold chain equipment and temperature monitors. For vaccine programmes in the GCC and regional export markets:

• **PQS pre-qualified** temperature monitors are preferred for GAVI and WHO-funded programmes
• Data loggers and cold chain equipment supporting vaccine distribution should be **performance-verified** against WHO specifications
• Validated shippers and monitors give regulators confidence in excursion data

Building your qualification package

• Start with **validated** equipment — loggers with NIST-traceable certificates and shippers with published thermal performance
• Run **OQ** against your worst-case Gulf ambient profile
• Close with **PQ** shipping studies using qualified monitors
• Keep an updated validation summary per shipper and lane

Royal Kana supplies WHO-aligned temperature monitors and validated TempLink shippers and supports qualification documentation for GCC pharma and vaccine programmes.

Need help with your cold chain setup? Contact Royal Kana.