Temperature mapping – an introduction.
Posted by:Steve Todd, Posted on:14 July 2016 – Categories:Compliance matters, Good distribution practice
GDP Guidelines Chapter 3.2.1
“An initial temperature mapping exercise should be carried out on the storage area before use, under representative conditions.
Temperature monitoring equipment should be located according to the results of the mapping exercise, ensuring that monitoring devices are positioned in the areas that experience the extremes of fluctuations.
The mapping exercise should be repeated according to the results of a risk assessment exercise or whenever significant modifications are made to the facility or the temperature controlling equipment.
For small premises of a few square meters which are at room temperature, an assessment of potential risks (e.g. heaters) should be conducted and temperature monitors placed accordingly”.
It has become apparent during inspections that some companies are unclear as to what is expected of them to comply with this requirement in the GDP Guidelines.
This seems particularly apparent with new applicants and those companies with small storage areas, possibly a few shelves or small refrigerators, to which this blog is particularly aimed.
Some larger storage areas may employ the expertise of a third party company specialising in this area.
Guidelines say that mapping should take place, but it does not state how this should be done.
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