The MHRA (The Medicines and Healthcare products Regulatory Agency) have recently revisited this issue with vengeance, clarifying their policies and making cold-chain procedure a prominent part of GDP inspections of both pharmacies and wholesale dealers. Failure to comply with cold chain procedure features on the top list of deficiencies found and published by the MHRA for each of the last three months.
The MHRA comment on their website specifically that Standard domestic refrigerators are not ideal for storing cold chain products for a number of reasons, including an uneven temperature distribution (as a result of minimal air circulation)
During GDP inspections of pharmacies that also hold a wholesale dealer’s licence, the MHRA have logged instances where the pharmacy refrigerator is also being used by staff for the storage of milk and food as well as medicinal products!
Consequently, any company storing refrigerated medicines should take steps to comply now. Don’t wait to be caught out at your next MHRA inspection. A large number of organisations needs to comply, pharmacies are obvious culprits but equally medical suppliers holding a WDL (Wholesale Dealers Licence) as well as end users, such as occupational health departments within British Industry.
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