JPAC Joint United Kingdom (UK) Blood Transfusion and Tissue Transplantation Services Professional Advisory Committee

EU Blood Inspection

Development of pan-European standards and criteria for the inspection of blood establishments (EU-Blood-Inspection) - EUBIS

The EU-Blood-Inspection Project falls within area 2.2.4 of the Public Health Programme (2003-2008) - Call 2006 - addressing the quality and safety of blood. The Project is targeted at those responsible for the operation of blood establishments and those responsible for inspecting them, in compliance with the requirements of Directive 2002/98/EC and its technical annexes.

NBS is a working Group leader for this project. MHRA has input through the Irish Medicines Board and have been invited by the project team to input into the process.

Projects objectives:
The overall objective of the Project is to develop and implement commonly accepted criteria and standards to ensure equivalent recognition of inspection of blood establishments among Member States.

It will deliver this through the development of a manual that will define:

  1. common inspection criteria and standards for the inspection of blood establishments
  2. requirements for the implementation or expansion of quality management systems to be inspected
  3. the development of inspection checklists which closely follow Directive 2002/98/EC and its technical annexes
  4. evaluation criteria for inspections and a benchmark system for deviations and improvements

The manual will be used as a basis of a training programme for the inspectors of blood establishments. This will ensure that the standards and criteria are commonly accepted.

It has been recognised that this document will also be useful for Hospital Blood Banks who are subject to inspection by their competent authorities. The draft, currently being circulated for comment, largely reflects the current approach taken by the MHRA when inspecting UK Blood Establishments and Hospital Blood banks.

Link to the projects web page: