Practical QA guidance

Practical knowledge about temperature mapping

Clear explanations for pharmacies, laboratories, clinics, GDP distributors and SMEs. Practical enough to understand, careful enough for QA, audits and inspections.

Common questions

  • Which guideline applies to my situation?
  • How many measurement points are needed?
  • When should mapping be repeated?
  • Is summer and winter mapping needed?
Start here

What is temperature mapping?

The essentials: purpose, hot spots and cold spots, method and study duration – with links to every subtopic.

Core concept

What 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.

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Monitoring

What is the difference between monitoring and temperature mapping?

Why monitoring follows from mapping, and why continuous monitoring without mapping cannot prove it watches the right spot.

Guidelines

Which guidelines apply to temperature mapping?

Practical explanation of EU GDP, IGJ FAQ, WHO, ISPE, pharmacies, cold chain, HACCP, medical devices and IVDs.

Dossier

What 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.

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Protocol & report

What 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.

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Audit

What do auditors want to see in a temperature mapping?

Checklist for an audit-ready mapping dossier: protocol, report, calibration certificates, raw data, deviations, CAPA and monitoring positions.

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Measurement points

How many measurement points are needed?

A practical explanation of the number of data loggers for fridges, freezers, storage rooms and cold rooms.

Requalification

How often should mapping be repeated?

When a new mapping is needed, including changes, repairs, recurring deviations and summer or winter conditions.

Prefer direct advice?

Tell us what you store and where. We will help determine what is needed.

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Free tools

Turn knowledge into a practical choice

Use the 3D mapping tool to create a first measurement point proposal, or use the other tools to check audit readiness, monitoring position and service level.

3D mapping tool for temperature mapping