GDP and storage of medicines
Good Distribution Practice requires medicines to be stored and transported within their temperature window. And that you can prove it for the whole room, not just the middle.
What does GDP require of temperature monitoring in a warehouse?
GDP is about a medicine having the same temperature window all the way from manufacturer to patient. That applies in the warehouse, in the cold room, on the loading dock and in the vehicle.
For a warehouse this means two things. Measurement must be continuous with calibrated sensors, and the placement of the fixed sensors must be justified. The latter is what is most often missing. Without a mapping study there is no documentation that the sensor sits where conditions are worst.
A mapping study shows the distribution in the room over time and identifies the warmest and coldest point. That is why, in practice, GDP also requires the study to be repeated after changes, and often in both summer and winter, because the warmest point moves with the season.
The number of measuring points and the acceptance criteria are set by you according to your risk assessment. We carry out the mapping and advise on placement.
What GDP requires in practice
The whole room, not the middle
The temperature must be held everywhere goods are stored, not just where the sensor happens to be.
Justified placement
A mapping study documents where the warmest and coldest points are, and why the sensor sits there.
Summer and winter
If the room is affected by the outdoor temperature, the warmest point moves. A study from January does not document July.
During transport too
Cool bags, boxes and trailers are part of the chain. A logger in the shipment documents the journey.
Alarm and response
An alarm must go off on deviation, and the response must be documentable afterwards.
Traceable calibration
The sensors must be calibrated with a traceable certificate, so the measurement has a known uncertainty.
What we deliver, and what you are responsible for
We carry out the mapping study, supply the system and the documentation, and advise on placement based on data. Acceptance criteria, the number of measuring points and the assessment of whether your practice meets GDP lie with you or your QA.
From mapping to a documented warehouse
The order matters. The study first, the fixed sensors afterwards.
Mapping study
Calibrated loggers are placed according to an agreed plan and run during normal operation, so the readings are representative.
Report
Heat maps, min, max and average per point, and time-stamped raw data. Readable without further explanation.
Fixed monitoring
The fixed sensors are placed where the study points. The door is monitored, so an open door shows up as the cause.
Repetition
A new study after changes in layout, ventilation or load, and typically in summer and winter.
Frequently asked questions
Does GDP require a mapping study?
GDP requires conditions to be documented throughout the room. A mapping study is the recognised way to do that, and it is what an inspection typically asks about.
How many fixed sensors are needed?
That is determined by the study and by the size and zones of the room. A small cold room can be handled with a few points, a large warehouse needs more.
Do we need to map in both summer and winter?
If the room is affected by the outdoor temperature, yes. Otherwise you are only documenting half of the year.
Does GDP also apply in the vehicle?
Yes. Transport is part of the distribution chain. A logger in the shipment documents the journey and is read on receipt.
What is the difference between GMP and GDP?
GMP covers manufacturing, GDP covers storage and distribution. Many companies are covered by both.
How often do we need to map again?
According to your own SOPs, and always after changes in layout, ventilation, fittings or load.
De bruger os allerede
Kom hurtigt i kontakt med den rette specialist.
Vi hjælper med alt fra nye monitoreringsløsninger til kalibrering, validering og teknisk support.
Generelle henvendelser
Nye projekter
IT & teknik
Administration
Besøg os
Måløv Byvej 229
2760 Måløv
Ring til os
+45 72 22 02 05
Man-fre, 08-16
Fortæl os, hvad du har brug for.
Vil du se, hvordan det ser ud hos jer?
Book en gennemgang. Vi kommer forbi, ser på udstyr og lokaler og rådgiver om, hvor følerne skal sidde. Derefter får du et skræddersyet forslag. Uden forpligtelser.
Book en gennemgang