How can we help you?

• Perform temperature mapping compliant with EU GDP 2013/C 343/01 and GMP Annex 15 with full IQ/OQ/PQ documentation
• Identify hot and cold spots and critical zones before a GIF inspector does
• Cover warehouses, pharmacies, cold stores and refrigerated vehicles in one service
• Obtain a certified validation report accepted by the Chief Pharmaceutical Inspectorate
• Conduct summer and winter season studies to ensure year-round regulatory compliance

What is GDP Temperature Mapping?

Temperature mapping confirms uniform temperature conditions throughout a storage area. It is mandatory under EU GDP guidelines 2013/C 343/01, GMP Annex 15, and national pharmaceutical storage regulations.

Temperature Requirements

• Medicinal products: +2°C to +8°C (biologics) or +15°C to +25°C
• Medical devices: per manufacturer requirements
• Frozen food: ≤ -18°C
• GDP transport: temperature distribution documentation throughout transit

Service Workflow

1. 1Mapping protocol development (URS, DQ)
2. 2Installation Qualification IQ - refrigeration equipment verification
3. 3Operational Qualification OQ - empty room, summer and winter conditions
4. 4Performance Qualification PQ - fully loaded conditions
5. 5Results analysis and hot & cold spot identification
6. 6Certified report with corrective recommendations

Covered Facilities

• Pharmaceutical wholesalers and warehouses
• Pharmacies (including hospital pharmacies)
• Food cold stores and distribution warehouses
• Refrigerated and isothermal vehicles (GDP)
• Pharmaceutical transport containers

Frequently Asked Questions