Temperature mapping study checklist
Everything to settle before loggers go in, watch during the study, check in the analysis and include in the report.
33 items · Based on WHO Technical Supplement 8 (TRS 961 Annex 9), EU GDP chapter 3, EU GMP Annex 15
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Before the study
During the study
Analysis
Report and follow-up
General technical guidance written against the cited sources. Adapt it to your procedures; it is not a substitute for the applicable standard or a qualified reviewer's judgement.
Background reading
What a temperature mapping protocol should contain
The protocol is the contract for the study: fix the purpose, limits, sensor plan and analysis rules before a single logger is placed.
What a temperature mapping report should contain
A report is a technical record that lets a reader who was not present understand what was done, what was found and what was decided.
Data-quality checks before analysing mapping data
Statistics computed on bad data are precise and wrong. Check the data first.
Common temperature mapping mistakes
Most failed studies fail before the loggers are placed — in the plan, the metadata or the calibration.