European Project adressing the safety
of blood transfusion
Work in progress
The first project phase – Survey for standards and criteria:
The specific objectives of this survey are to define the current situation of standards and criteria used for inspections of blood establishment among the participants from 16 established, new, applicant and EFTA states in order to identify (A) international and national inspection guidelines in place and (B) the current inspection practice.
Using commonalities between Member States and the requirements and definitions given by the European Commission blood legislation with its Directives, the Project will develop a manual, defining requirements for the structure of quality management systems based on Directive 2002/98/EC and its technical annexes.
Based on these requirements, inspection standards and criteria (GUIDELIENS) will be developed to assist in the independent assessment of quality system structures established by individual blood establishments in relation to the requirements in the EU-legislation on blood. The inspection manual will also assist blood establishments in preparing for inspections. Inspection standards and checklists used for external inspection by independent inspectors could be used for internal audits by blood establishments. Defining principles for the structure of quality systems will assist in implementing or expanding the currently used quality management systems in blood establishments. It will ensure the incorporation of standard operating procedures (SOPs) in a site master file or a quality management handbook reflecting GMP standards.
In this respect, the Project's objectives are targeted at those (A) operating blood establishments and those (B) responsible for inspecting blood establishments.