Practical knowledge about temperature mapping
Clear explanations for pharmacies, laboratories, clinics, GDP distributors and SMEs. Practical enough to understand, rigorous enough for QA.
Frequently asked questions
Practical guidance on monitoring, guidelines, measurement points and requalification.
What is temperature mapping?
The essentials: purpose, hot spots and cold spots, method and study duration – with links to every subtopic.
Read article Core conceptWhat are hot spots and cold spots?
The warmest and coldest points in a room: where they occur, why they determine storage risk and how mapping turns them into the right monitoring position.
Read article MonitoringWhat is the difference between monitoring and temperature mapping?
Why monitoring follows from mapping, and why continuous monitoring without mapping cannot demonstrate that the correct location is being monitored.
Read article GuidelinesWhich guidelines apply to temperature mapping?
Practical guidance on EU GDP, GMP, WHO, ISPE, summer and winter mapping, cold chain, HACCP and medical devices.
Read article DossierWhat is included in a mapping dossier?
See how a mapping and qualification dossier is structured according to WHO/ISPE principles, from scope and risk to analysis, conclusion and annexes.
Read article ProtocolWhat is included in a temperature mapping protocol?
A practical protocol structure with scope, logger placement, study duration, acceptance criteria and the link to the final report.
Read article Protocol & reportWhat is the difference between a mapping protocol and report?
The protocol defines the measurement setup and acceptance criteria in advance. The report presents the results, deviations, conclusions and appendices afterwards.
Read article AuditWhat do auditors want to see in a temperature-mapping study?
Checklist for an audit-ready mapping dossier: protocol, report, calibration certificates, raw data, deviations, CAPA and monitoring positions.
Read article Inspection analysisRecent observations from GDP/GMP inspections
Analysis of 58 public GMP/GDP inspection reports and 37 findings on temperature control, mapping, monitoring and contractual responsibilities.
Read analysis GDPWhat does GDP require for temperature mapping?
Practical guidance on initial mapping, representative conditions, monitoring positions, study duration and remapping under EU GDP.
Read article Measurement setupHow many measurement points are needed?
A practical explanation of the number of data loggers for fridges, freezers, storage rooms and cold rooms.
Read article Logger placementWhere should you place data loggers for temperature mapping?
Practical guidance on product locations, height differences, door zones, airflow and the link to your final monitoring position.
Read article RequalificationHow often should mapping be repeated?
When a new mapping is needed, including changes, repairs, recurring deviations and summer or winter conditions.
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