How to perform Temperature Mapping

In a recent blog of the U.K. Medicines and Healthcare Products Regulatory Agency (MHRA), the inspectorate looks at temperature mapping. It seems that "some companies are unclear as to what is expected of them to comply with this requirement in the GDP Guidelines", the Agency says.

The requirement itself is defined in the GDP Guidelines Chapter 3.2.1: "An initial temperature mapping exercise should be carried out on the storage area before use, under representative conditions." The results of this mapping should be used to place monitoring devices at areas that experience the most temperature differences and the hot and cold spots. Any potential area that may be unsuitable to store medicines should be identified. Therefore, mapping should be performed before stock is stored. However, the MHRA also recommends to repeat the mapping when the storage area is operating (taking into account seasonal variations).

What to consider:

  • Identify crucial storage areas: highest point of storage, heaters, coolers, lighting, windows, doors, loading bays etc.
  • Use calibrated monitoring devices in sufficient numbers
  • Record and assess data
  • Repeat mapping to cover for seasonal variations or if the storage area is (subsequently) reconfigured

Please also see the MHRA Inspectorate Blog "Temperature mapping – an introduction".

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