What GDP expects from temperature mapping
EU GDP asks for an initial mapping exercise before use, repeated after significant changes — and for the results to drive where monitoring equipment is placed.
The EU GDP guideline places temperature mapping under premises and equipment: an initial temperature mapping exercise should be carried out on the storage area before use, under representative conditions, and mapping should be repeated according to the results of a risk assessment or whenever significant modifications are made.
What follows from that
- 'Before use' means the study is part of qualification, not a later check.
- 'Representative conditions' is the argument for loaded studies and for considering seasons.
- Repeat mapping is triggered by change (racking, HVAC, layout) and by a documented risk assessment.
- Monitoring equipment should be placed according to the mapping results, at the areas of greatest variation.
The guideline states expectations, not methods. The method — sensor count, duration, analysis — comes from technical guidance such as the WHO supplement and from the organisation's own protocol.
Frequently asked questions
- How often does GDP require temperature mapping to be repeated?
- GDP does not set an interval. It requires repetition according to a documented risk assessment and whenever significant modifications are made to the facility or equipment.
- Does GDP require mapping of small refrigerators?
- The requirement applies to storage areas and equipment used to store medicinal products; in practice every refrigerator holding product is mapped before use.
References
- [1]EU Guidelines on Good Distribution Practice of medicinal products for human use (2013/C 343/01)
- [2]WHO Technical Supplement 8 to TRS 961 Annex 9: Temperature mapping of storage areas (2015)
General technical guidance written against the cited sources. It is not regulatory or legal advice and does not replace the applicable standard, guideline or a qualified reviewer's judgement.
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