MHRA Requirements At A Glance
In February 2007 the MHRA (Medicines & Healthcare products Regulatory Agency) revised the ‘Orange Guide’ which is a set of rules and guidelines outlining GMP (General Manufacturing Practice) for Pharmaceutical manufacturers and distributors.
Detailed within the guide are the precise conditions required for the storage of drugs at “controlled room temperature”, basically those labelled “store below 25ºc”.
In simple terms, compliance with MHRA regulations requires the following:-
- The MKT remains below 25ºc at all times. MKT (Mean Kinetic Temperature) is a complex temperature average that predicts the effect of high and low temperatures on pharmaceutical products over time.
- The instantaneous temperature only exceeds 25ºc under exceptional circumstances. Exceptional circumstances will usually mean unexpectedly high outside temperatures, and if these conditions occur it’s likely that air conditioning will fail altogether and result in failure to comply with the next point also.
- The instantaneous temperature NEVER exceeds 30ºc. If it does, then you are non-compliant even if the MKT remains below 25ºc. 30ºc can easily be exceeded if an air conditioning system fails at high outside temperatures.
- The temperature properties of your building are understood. So storage and temperature control systems can avoid “hotspots,” temperature mapping a building is often required so that you can fully understand its thermal properties.
- Temperature conditions are monitored and recorded. Without monitoring it’s impossible to demonstrate compliance with the guidelines, and often if a breach is suspected the only safe course of action is to dispose of more stock than would be required otherwise.
Procool’s fully integrated Pharmacool Evaporative cooling system will guarantee to meet all of the conditions above – and we are currently the only company in the UK that does!