The MHRA recently hosted a programme of workshops aimed at improving compliance with the Blood Safety and Quality Regulations.
Key topics included best practice, incident reporting, validation, as well as self-inspection. The Clinical Services Journal reports.
Set up in April 2003, following a merger of the Medicines Control Agency and the Medical Devices Agency, the Medicines and Healthcare products Regulatory Agency (MHRA) is the Government agency responsible for ensuring the safety of medicines and medical devices – thereby safeguarding public health. This remit is wide-reaching and covers areas such as assessing the safety, quality and efficacy of medicines and medical devices – ensuring they meet acceptable standards, investigating and monitoring related adverse reactions and promoting good practice regarding their use. As of November 2005, the MHRA has also been the competent authority responsible for inspecting UK hospital blood banks to ensure compliance with the Blood Safety and Quality Regulations (BSQRs). BSQRs are now a requirement for hospital blood banks and effectively cover all aspects relating to the use of human blood and blood components in hospitals; encompassing areas such as collection, testing, processing, storage and distribution – thereby contributing to better blood transfusion. As these regulations impact on every hospital with a blood bank, the MHRA recently went on the road, throughout the UK, to present a series of informative seminars related to implementing good practice – visiting areas such as Birmingham, Cardiff, Belfast and Glasgow, in addition to holding several additional seminars at their head office at Market Towers, London.
Key issues
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