Temperature & RH Mapping


(Thermal Mapping / Qualification)

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:

Temperature and relative humidity mapping on warehouses and storage areas

  • Warehouses and storage areas
  • Production areas
  • Incubators/cabinets
  • Cold rooms/fridges/freezers
  • Pharmacies
  • Transport vehicles/containers/reefers (Transport Validation)
  • Hospitals
  • Veterinary clinic

The areas can be mapped empty, full, simulate loaded or as found.

The service includes:
Stability Chamber

  • An assessment of the area, highlighting savings/efficiencies/compliance gaps where applicable.
  • Compilation of the protocol and approved 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.

Temperature RH MappingAs temperature/RH mapping ad regulatory specialists we ensure:

  •  All protocols and reports are signed off 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.
  • In addition 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 3 point calibrated across the range required and traceable to an international standard.  All calibration certificates are supplied with the study.
  • Calibration is completed by accredited laboratory in a controlled environment against a traceable standard.
  • Correction factor/off set available as point of use/mapping if required.

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 for example:

Irish Republic USA United Kingdom World Health Organisation Canada PDA Technical Report No. 39
  • Irish Medicines Board: Guide to control and monitoring of storage and transportation temperature conditions for medicinal products and active substances
  • 21CFR 211.142 and 211.150 (storage and distribution)
  • USP Chapter 1079: Good storage and shipping practices
  • Recommendations on the control and monitoring of storage and transportation temperatures of medicinal products for human use
  • Guidelines on GDPs are incorporated into volume 2, good manufacturing practices and inspections, in “Quality Assurance of Pharmaceuticals
  • Food and Drug Regulations, section C.02.015
  • Guidelines for temperature control of drug products during storage and transportation (Guide – 0069)
  • Cold chain guidance for medicinal products: maintaining the quality of temperature-sensitive products through the transportation environment

 

 

Transport Validation

Previous/ongoing mapping clients:

 

Kevin O
Kevin O'Hara, Warehouse Manager Teva

FQS carried out mapping for us. Their work certainly ticked all the boxes and their standard of service and knowledge of legislation and requirements was excellent. Notably, FDA Reporting was provided in a tamper proof PDF format and CFR21 Part 11 compliant software was used.

Protocols and reports contained up to date relevant information meeting all the requirements of different regulatory authorities and were written in an easy read format. I found that reports were returned in a timely fashion and a logical reason was always provided for each logging position following the risk assessment of a location.

‘I would not hesitate in calling FQS with a compliance or temperature mapping query. FQS are reliable and always follow up punctually – I would recommend them without reservation’.

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