A reminder of what information hospital blood banks need to provide to the MHRA
[U][COLOR=#4472c4][FONT=Calibri][SIZE=3]A reminder of whatinformation hospital blood banks need to provide to the MHRA[/SIZE][/FONT][/COLOR][/U]
[COLOR=#4472c4][FONT=Calibri][SIZE=3]Hospital Blood Banks arerequired to report any changes that might affect their compliance with the requirements of the Blood safety and Quality Regulations 2005 (As amended).These should be reported immediately via [/SIZE][/FONT][COLOR=#4472c4][FONT=Calibri][SIZE=3]gmpinspectorate@mhra.gov.uk[/SIZE][/FONT][/COLOR][FONT=Calibri][SIZE=3]. [/SIZE][/FONT][/COLOR]
[COLOR=#4472c4][FONT=Calibri][SIZE=3]It would be helpful if the following changes were reported to [/SIZE][/FONT][COLOR=#4472c4][FONT=Calibri][SIZE=3]bcr@mhra.gov.uk[/SIZE][/FONT][/COLOR][FONT=Calibri][SIZE=3] :[/SIZE][/FONT][/COLOR]
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[LIST][*][FONT=Times New Roman]Changes to company or NHS Trust (where the blood bank is sited), e.g. a merger of Trusts[/FONT][*][COLOR=#4472c4][FONT=Times New Roman]Changes to main contact for the BC[/FONT][/COLOR][FONT=Times New Roman]R[/FONT][*][FONT=Times New Roman]Changes to the organisation that manages the hospital blood bank, e.g. the formation of a pathology partnership
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[FONT=Times New Roman][COLOR=#4472c4][FONT=Calibri][SIZE=3]Other significant changes should be noted on the annual bcr:[/SIZE][/FONT][/COLOR]
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[LIST][*][FONT=Times New Roman]Changes to laboratory systems e.g. analysers or LIMS[/FONT][*][FONT=Times New Roman]Changes to key personnel e.g. blood bank manager, quality manager[/FONT][/LIST]
[/SIZE][/FONT][/COLOR][/FONT][FONT=Times New Roman][COLOR=#4472c4][FONT=Calibri][SIZE=3][FONT=Times New Roman][SIZE=3][COLOR=#000000]
[/COLOR][/SIZE][/FONT][COLOR=#4472c4][FONT=Calibri][SIZE=3]All changes must of course be introduced via a formal change control process.[/SIZE][/FONT][/COLOR]
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