Temperature Mapping Protocol
Mapping protocol that finds where a storage area is actually out of range: mapped loaded in the real pattern, sensors placed to find extremes rather than confirm the middle, duration covering real cycles and working activity, seasonal extremes and failure modes challenged, and permanent monitoring placed at the extremes the study found rather than where cabling is convenient. Maps to WHO TRS 957 Annex 5 and USP <1079>.
What a template is not
A template is a document baseline to adapt inside your own quality system. SPEQ does not approve, validate, or take responsibility for what you issue from it, and using one is not evidence of compliance.
Mapping establishes the real distribution of temperature across a storage area under the conditions it actually operates in, so permanent sensors can be placed where an excursion will be detected. A store monitored at one convenient point is monitored at the place nobody needed to know about. Where the extremes are is a finding; where you then place the sensors is your determination.
What's Inside
How to Use It
The full section structure of this template — every section and sub-section, so you can use it as a baseline for your own site document.
WHO TRS 957 Annex 5 sets the good storage and distribution practice expectations for temperature-controlled areas, including mapping before use and the placement of monitoring devices, and USP <1079> addresses monitoring of storage and distribution environments. Neither prescribes how many sensors your area needs, how long the study runs, or which season is worst case for your building — those determinations are yours, and this protocol asks you to record their rationale.