Date lodged: 21 July 2017
To ask the Scottish Government what information it has on how much of the Bio Products Laboratory (BPL) products that are used in Scotland are affected by the reported findings of the Medicines and Healthcare products Regulatory Agency (MHRA) following a routine inspection of BPL laboratories.
Answered by: Shona Robison 15 August 2017
The MHRA has informed the Scottish Government that there is no evidence to indicate that this incident has resulted in any increased risk to patient safety. They do not envisage any disruption to the supply and availability of BPL plasma products.
During a recent routine inspection of Bio Products Laboratory (BPL) plasma centres, Medicines and Healthcare products Regulatory Agency (MHRA) inspectors identified poorly validated software which resulted in a concern that there may have been issues with the plasma collection processes. These issues were traced to a change in IT software.