Good Manufacturing Practice This series of education materials was put together to help Hospital Blood Transfusion Laboratories:-
Understand the impact on the hospital blood transfusion laboratory
Understand the requirements of GMP
For Quality Managers/ Blood Transfusion Managers to deliver this training session to all staff working in the blood transfusion laboratory
GMP presentation - pdf (949KB)
Assessment Questionnaire - pdf (28KB)
Assessment Questionnaire answers - pdf (29KB)
Set of nine posters - pdf (718KB)
A3 poster combing the 9 individual posters - ppt (829KB)
Certificate - Word document (23KB)
If you collect and deliver blood and components you must be officially trained to do this with documentation to confirm it.
Quality specifications require 100% compliance with correct labelling on samples.
The responsibility for achieving 100% for traceability lies with the person administering the blood. You must sign and return one part of a new 2-part blood label.
You must be aware that it is a legal requirement to report any adverse events or reactions to the Blood Bank for them to investigate and report to the MHRA.
Ensure that you know the correct storage requirements for blood and components and return any units that will not be transfused to the Blood Bank within 30 minutes.
If you collect blood and components you must be trained to do so; have documented evidence of training and update this at regular intervals. You must also ensure full documentation of transfusion episodes.
If you work in transfusion you must be officially trained in all procedures. Documented evidence of training must be maintained.
SOP’s must be adhered to.
A Quality Management System must be in place.
Strict document control must be adhered to.
Follow up of non-compliance for traceability of blood components will be your responsibility.
Divisional General Managers
Compliance with the BSQR is a corporate responsibility. Make yourself aware of what this means for you.
For further information contact members of the Trust Transfusion Team