Temperature Mapping and GDP
The exposure of medicines to high temperatures during storage or transit has a detrimental effect on product quality including efficacy and therefore should be avoided in the interest of patient safety.
In order to maintain product integrity it is essential that products are stored at correct temperatures (as recommended by the manufacturer) across the supply chain.
Chapter 3, Clause 3.2.1 of the latest Good Distribution Guidelines state:
Suitable equipment and procedures should be in place to check the environment where medicinal products are stored. Environmental factors to be considered include temperature, light, humidity and cleanliness of the premises.
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.
Temperature Mapping involves a process of recording the temperature of used for the storage of pharmaceutical medicines. This includes warehouses, fridges, freezers and vehicles used for transportation.
A well planned and executed temperature mapping exercise is essential as it can provide a complete profile of spatial temperature variations within an enclosed space as a snapshot in time.
Armed with the information and taking a risk based approach, corrective plans can be implemented before the area is declared suitable for storage.
Temperature Mapping Service
To comply with regulatory guidance it is important any mapping exercise is performed using calibrated data loggers.
Initial exercises should be repeated to take into account extreme seasonal variations such as summer and winter and repeated every 18 months as a minimum and after any significant modification such as structural changes to the premises, stock layout, or heating and ventilation systems.
Our comprehensive Temperature Mapping service for small to medium sized warehouses includes:
- Protocol Development
- Trial execution
- Data Analysis, and
Pharma Experts provides both hard and electronic copies of temperature mapping reports.
Are you compliant?
According to the MHRA Inspectorate temperature and storage conditions are most common Good Distribution Practice (GDP) deficiencies and often ranked “major” and “critical”.
When was the last time you mapped out your warehouse, fridge, freezer or delivery vehicle?
Are your temperature data loggers calibrated?
Are you and your team trained on the importance of Temperature Monitoring with regards to Good Distribution Practice?
If you are ready to work with us, or would like to discuss in further detail about how we can help you and your organisation please contact our office and send us your request, or schedule a free initial telephone consultation.