| Mike Meakin and Jeroen Martens of DHL Exel Supply Chain outline their initiatives around improving the cold chain operations from storing and distributing products from pallets to cartons within Europe
The healthcare market has seen an increase in the amount of cold chain storage required to meet the increasing demands and complexity of clinical trial studies, new bio pharma products, chemical chemistry devices with re-agents, biotech and new nanotechnology products requiring both refrigerated and deep-frozen solutions. Human and veterinary medicines and blood products, as well as their primary and secondary distribution from manufacturer through to local wholesalers and distributors and beyond to pharmacies and doctors with vaccines are all implicated.
Numerous studies have proven that, even if storage facilities are highly controlled and easily qualified and validated, when a product is being transported there are too many variables and possibilities that things can go wrong to enable validation. Hence, greater visibility and control in the supply chain enhances GCCMP capabilities, thereby reducing waste and improving patient safety, detection visibility and service around product availability.
John Taylor and Ian Holloway of the MHRA have both recently presented on good distribution practice (GDP) and cold chain management at a Life Science Conference and Healthcare Quality forum. They provided advice on the challenges facing the supply chain, including regulatory compliance, emerging markets for clinical trials, increasing complexity of chains and products, and other issues such as counterfeit products and global warming. They have also explained their concerns about temperature control – between a third and a half of all critical and major GDP deficiencies relate to the control and monitoring of storage and transport temperatures. Seventeen per cent of serious GDP deficiencies recorded by MHRA inspectors in 2005/06 in the UK were related to the temperate supply chain. |
