Whilst the EU GDP Guidelines do not specify exactly what humidity controls should be in place, the general answer received by the regulatory bodies is check the product requirements. As a point that is being brought up more frequently in inspections it is such a ‘grey area’.
For temperature’s this is easy enough, 2-8c, 15-25, or 8-25. For humidity, you tend to just read ‘Protect from moisture’.
W.H.O. have advised that this should mean keeping storage conditions under 60% Relative Humidity (RH). So, what can you do to detect or monitor this humidity?
The best way would be to ensure you use a humidity logger whilst conducting temperature mapping exercises and testing high risk areas within your storage facility. Once the highest risks have been identified then make sure you set up regular monitoring with your humidity logger. These areas could be near windows or heaters, very much like the risk areas for temperatures.
In the event of high RH levels, W.H.O. have advised the following recommendations; open a window to allow airflow but ensure it is still secure enough to prevent unauthorised access by insects, birds, animals and humans. Keep stock on pallets to allow airflow around the boxes. Keep boxes secure and do not open them unless necessary. Use fans to distribute air around storage facilities or if possible install air conditioning or dehumidifying equipment.
Until such a time that more guidance is released by the regulatory bodies it would be advisable to monitor the 60% RH advice from W.H.O. unless otherwise stated on the product storage requirements. Just ensure that it states that in your SOP’s and you can explain to the regulators why you have chosen this limit.
If you do require assistance with your temperature and humidity mapping and monitoring, then Pharmacy Consulting are here to help. We can help in setting up mapping exercises, completing mapping reports and even provide data loggers.
