Temperature control under EU GDP: what is expected
EU GDP requires premises and equipment that maintain storage conditions, initial mapping before use, calibrated monitoring equipment, alarms, and records that demonstrate control.
Chapter 3 of the EU GDP guideline (premises and equipment) sets the temperature expectations for wholesale distributors. Storage areas must be designed or adapted to ensure required storage conditions; equipment used to control or monitor the environment must be calibrated, and its calibration records kept; alarm systems must be in place to warn of excursions; temperature mapping must be carried out before use.
The practical chain
- Qualify the space: initial mapping under representative conditions.
- Place monitoring equipment where the mapping showed the greatest variation.
- Calibrate monitoring equipment and set alarms according to the product limits.
- Record continuously; review records; investigate excursions and assess impact.
- Re-map after modifications or as the risk assessment requires.
Chapter 9 extends the same expectations to transportation: temperature-controlled vehicles and containers must be qualified and monitored.
Frequently asked questions
- Does GDP specify how many sensors to use for mapping?
- No. It requires mapping under representative conditions; the method is left to technical guidance and the distributor's risk assessment.
- Are ambient (15–25 °C) stores exempt from mapping?
- No. The requirement applies to storage areas generally; ambient stores are frequently where the largest gradients occur.
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.
Have a question on this topic?
Ask ValiTrac AI and see the evidence and calculation behind the answer.
Ask ValiTrac AIFree calculator: MKT & logger data check
Paste logger readings and get MKT per ICH Q1A(R2) alongside min, max, mean and out-of-limit runs with durations.
Open the calculatorRelated articles
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.
Handling temperature excursions in storage and distribution
An excursion is a deviation: contain, record, assess product impact against stability data, decide, and learn. The record must show all five steps.