Qualification & Validation - Temperature & RH Mapping
Qualification & Validation - Temperature & RH Mapping
FQS offer an onsite service which includes Temperature and relative humidity
mapping/Thermal Qualification assessing the area for compliance with required
storage conditions. The area is mapped and assessed against the required
standards and regulations. Temperature and relative humidity (RH) mapping /Thermal
mapping is essential to remain in compliance and to ensure product can remain
stable for the full shelf life. Temperature mapping also known as thermal mapping,
thermal validation, temperature validation and room qualification.
Temperature and relative humidity mapping / Thermal
Qualification can be carried out on the following areas:
Warehouse &
Storage Areas
Production
Areas
Incubators
/ Cabinets
Cold Rooms
/ Fridges
/ Freezers
Pharmacies
Veterrinary
Clinic
Hospitals
Transport Vehicles /Containers / Reefers
(Transport Validation)
Discover More On Our
Transport Page Here
The areas can be mapped empty, full, simulate
loaded or as found. The service includes:
• An assessment of the area, highlighting savings
efficiencies/compliance gaps where applicable.
• Compilation of a bespoke protocol and report.
• Quality Risk assessment completed to identity location of probes.
• Assess location for ongoing probes and provide justification for their location.
• Ensure area is in compliance with regulatory requirements.
• Execution of the protocol.
• Supply of Report with data in summary, graphical and table format.
• Supply of all calibration certificates with report.
• Recommendations provided
As temperature/RH mapping and regulatory
specialists we ensure:
• All protocols and reports are overseen by a Qualified Person with a MSc in Mapping.
• Advice given to mitigate against failure and Consultancy available if mapping fails.
End to End service available. Mapping protocol and reports compiled and executed by trained personnel.
• Mapping system used is a validated system and in compliance with Annex 11.
• Inaddition, prior to initiating mapping, the mapping probes are checked against a
calibrated probe certified to a traceable international standard.
• External conditions are monitored during mapping to ensure that the mapping study is
reflective of the season/extremes etc.
• FQS carry out a risk assessment of the area to determine the location and the number of probe required to map the area.
• Justification provided for number of probes and location of mapping probes.
• Results reviewed and justification provided for location of ongoing monitoring probes.
• All probes are minimum 3 point calibrated (up to 7 point) across the range required and traceable to an international standard. All calibration certificatesare supplied with the study.
Using our knowledge of both regulations and temperature monitoring equipment and
product requirements we ensure all protocols and reports are reviewed in compliance with relevant legislation and guidelines for control and monitoring of storage and transportation temperature conditions for medicinal products.
Previous/ongoing mapping clients:
