Blood collection and processing. Quality guidelines and standards reflecting common best practice standards referring to the EuBIS manual and guide

EuBIS, the European blood inspection system, is a collaborative effort of 27 representatives from 19 Member States (MS), including governmental institutions, blood establishments and competent authorities. EuBIS has been initiated by co-funding through the Public Health Programme (Directorate General Sanco) of the European Commission bringing together regulators (competent authorities) and manufacturers (blood establishments) to jointly develop criteria and standards aimed to assist: 1 blood establishments in need to optimize their quality system and self-inspection process and to prepare for regulatory inspections by competent authorities and 2 competent authorities, who wish to use the manual and training guide as a reference for the implementation process of legislative requirements related to regulatory inspections. These standards and criteria have been published in a EuBIS Manual and a EuBIS Training Guide. The structure of the EuBIS training guide follows critical aspects of quality management to be addressed to achieve good/best practice. For each of the quality related critical points, a criterion description, examples evidence and references to relevant international standards (GMP, PIC/S and CoE/EDQM CD-P-TS) and legislative requirements based on the European blood directives are given. Using ‘fishbone’ diagrams, quality indicators for risk assessment can be easily developed in a systematic fashion covering all relevant activities of a blood establishment. Chapter 3·5 refers to Blood collection, testing and processing with detailed subchapters on blood collection, processing and validation, labelling and release of blood and blood components. Additional quality requirements are described in Chapter 3·3 for Premises (Collection, Processing, Storage and Distribution), Chapter 3·4 Equipment and Chapter 3·8 non-conformance. Based on these standards and criteria, quality management systems have been nationally adapted to include reporting systems for risk analysis, prevention and acceptance based on deviations of processes, non conforming products and/or adverse events as well as non-compliances from audits and regulatory inspections.