Temperature Mapping Top Tips: Medicinal Product Storage Areas

Temperature Mapping: What the Regulations Say

Chapter 3.2.1 of the EU GDP Guidelines dictates:

“An initial temperature mapping exercise should be carried out on the storage area before use, under representative conditions.  Temperature monitoring equipment should be located in accordance with the results of the mapping exercise, ensuring that the 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 signification modifications are made to the facility of the temperature controlling equipment.” 

What does this mean? 

This means a mapping exercise of your potential storage areas for medicinal products must be part of your initial change control for setting up a medicinal product storage area.  It also means that mapping exercises should be repeated in accordance with risk.  Risks can include changes to heating and cooling systems, seasonal climates and equipment used to monitor temperature conditions.

What is a temperature mapping exercise? 

Basically, a temperature mapping exercise is a process of measuring and recording the temperature variations in a storage area over a given period of time, typically over the course of a full week, including weekends when warehouse activity may be reduced. However as a mapping exercise is based on risk, should your organisation adopt ‘factory shut down’ periods? For example, the whole operation closes for 2 weeks in the summer, temperature mapping exercises should be performed for the duration of the shut-down.  

Mapping exercises help to identify any hot or cold spots, as well as the minimum and maximum temperatures in the area and provide a better understanding of where best to store medicinal products so that their documented storage requirements are met at all times. 

Who can perform a temperature mapping exercise? 

As a critical area of GDP compliance which is essential for the quality and integrity of medicinal products stored in your premises, your temperature mapping exercise protocol should be a documented procedure. 

Only persons who have been trained and are deemed competent in the temperature mapping procedure should perform the mapping exercise. 

Top tips for performing a temperature mapping exercise: 

• Know the size of your storage area, this will help you identify the number of temperature monitoring devices needed to ensure all areas of the storage area are monitored during the exercise. 
• Identify potential hot and cold spots e.g. location of heating sources, entry and exit points, windows and artificial lighting. 
• Know where your medicinal products are to be/are being stored, don’t forget any areas for cold chain products. And remember, there is no need to temperature map areas where no medicinal products are stored. 
• Ensure you place your loggers at varying heights, in particular on racking to identify any areas that are subject to varying temperatures.
• Use calibrated temperature monitoring devices and configure them to record temperatures for the duration of the mapping exercises, allowing for any unforeseen circumstances.  
• Include any back up power or contingency plans during your mapping exercise; for example, if you have a generator for use during a power cut, test this works and monitor the temperatures as part of your exercise.  
• Monitor external temperatures throughout the exercise.
• Ensure all areas where medicinal products may be stored, e.g. goods in, quarantine, returns area etc. 
• Ensure the mapping exercise and results are analysed, documented, signed and shared with relevant personnel. 
• Raise CAPAs where needed. 

In conclusion 

A breakdown in temperature or environmental control within a facility storing medicinal products can result in significant regulatory repercussions, financial loss and reputational damage for the wholesaler.  

To prevent this, consistent maintenance and continuous temperature monitoring and control are essential to ensure the storage environment always remains within the required range, regardless of external weather conditions. 

Assistance and support 

Paradigm Shift Consulting Ltd provides quality management services, including temperature monitoring and control support and training to the pharmaceutical industry. 

We can help you with your temperature management needs by: 

• Performing initial temperature mapping exercises on your proposed storage areas. 

• Perform and/or assist with your ongoing re-mapping exercises. 

• Reviewing your existing temperature monitoring and control procedures and mapping exercise reports and assist with updating/reworking where required. 

• Conducting validation activities for your equipment, systems and processes. 

• Managing change control processes for your quality system or GDP operations. 

• Providing training on warehouse storage management and Good Distribution Practices for your staff. 

If you are interested in our services or have any questions about temperature mapping or GDP compliance in general, please contact us for a free, short consultation.