Temperature Mapping:

A risk-based approach to document temperature distribution in storage facilities

GDP compliant, End-to End-solution, GMP compliant document package


  • Need for increased storage capacity in API storage freezer room.

  • Storage racks needed to be implemented to optimally use vertically higher storage locations without interrupting proper air flow.

  • Need to map temperature in new upper locations of freezer room with product present.

  • Need to perform seasonal mapping during summer conditions (hot ambient temperatures).

  • Enhanced compliance level for temperature mapping was needed.

  • Need to use temperature loggers with better data resolution and analysis possibility.


  • Optimized placement of storage racks with increased storage capacity and proper air flow.

  • Storage locations with temperature excursions identified (and hence could be avoided).

  • Permanent temperature probes were relocated to new hot and cold spots.

  • Temperature mapping with high level of GDP compliance was performed.

  • Enhanced data resolution using sensitive and robust temperature loggers.


  • Project Management of storage racks implementation

  • Temperature mapping.

  • Coordination with client staff: user representatives, technical specialists, QA and others.

  • Provision of loggers and identification of mapping locations with rationales for each location.

  • Temperature mapping in compliance with regulatory requirements and client SOPs.

  • Root cause identification, correction and prevention (CAPA).

  • Complete GMP documentation (mapping protocol, report and deviations) delivered using client templates – all the way through QA approval.

contact for this case

Anders Helmer Nielsen

Mobile: +45 5099 8328
Email: ahn@amgroup.dk