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Temperature mapping – an introduction

Temperature mapping is the process of mapping the differences and changes in temperature that occur within a single temperature controlled system due to influences like opening doors, proximity to cooling fans, personnel movement, and the quantity of products being stored at any given time.

“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.

Why map?

To demonstrate by way of documented evidence that the chosen storage area is suitable for the storage of temperature sensitive medicinal products. As stated in one of my previous blogs, ambient products are also temperature sensitive.
A mapping exercise of the proposed storage area will ensure that the company will understand their storage area and identify any potential areas therein that may be unsuitable to store medicines.
A mapping exercise will also inform as to where permanent thermometers should be located.

When to map

If possible, before stock is stored.
This might not be possible where a storage area is being reconfigured. In smaller empty storage areas, dummy products could be used to simulate normal operational storage without compromising genuine product, including cold stores and fridges/freezers.
In an empty storage area, a mapping exercise should be repeated when fully stocked.
Data arising from the exercise should be documented and a risk assessment documented with any hot or cold spots identified. This exercise should then be repeated to take into account seasonal variations.

Contact Information

MAKTECH INDIA SYSTEM SERVICES
Shop no 10, Third floor, United Pride Complex,
At Beed bypass Road, Aurangabad.

Phone: 
Kuldeep Singh:+91 9158063777,
Amol Rajhans :+91 9096292193

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