European Project adressing the safety
of blood transfusion
Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use. Official Journal of the European Union L311, 28/11/2001, p.67.
Directive 2002/98/EC of the European Parliament and of the Council of 27 January 2003 setting standards of quality and safety for the collection, testing, processing, storage and distribution of human blood and blood components and amending Directive 2001/83/EC. Official Journal of the European Union, L33, 8/02/2003, p.30.
Commission Directive 2003/63/EC of 25 June 2003 amending Directive 2001/83/EC of the European Parliament and of the Council on the Community code relating to medicinal products for human use. Official Journal L159, 27.6.2003. p.46.
Commission Directive 2004/33/EC of 22 March 2004 implementing Directive 2002/98/EC of the European Parliament and of the Council as regards certain technical requirements for blood and blood components. Official Journal of the European Union, L91, 30/03/2004, p.25.
Commission Directive 2005/61/EC of 30 September 2005 implementing Directive 2002/98/EC of the European Parliament and of the Council as regards traceability requirements and notification of serious adverse reactions and events. Official Journal of the European Union, L256, 1/10/2005, p.32.
Commission Directive 2005/62/EC of 30 September 2005 implementing Directive 2002/98/EC of the European Parliament and of the Council as regards Community standards and specifications relating to a quality system for blood establishments. Official Journal of the European Union, L256, 1/10/2005, p.41.
Council Recommendation of 29 June 1998 on the Suitability of blood and plasma donors and the screening of donated blood in the European Community. (98/463/EC). Official Journal of the European Communities, L203, 21.07.1998, p.14.
European Commission Documents
European Commission, Health & Consumer Protection Directorate-General, Directorate C - Public Health and Risk Assessment, C6 - Health measures. Compilation of Responses from Competent Authorities: Questionnaire on the transposition and implementation of the European Blood and Blood Components regulatory framework, SANCO C6 TB/ci D(2008)/360028.
European or International Regulators
EMEA GMP inspection guidance documents: CoCP (Compilation of Community Procedures) Inspection Conduct (EMEA/INS/GMP/313513/2006) and report writing. EMEA/INS/GMP/313539/2006.
EudraLex, The rules governing medicinal products in the European Union, Volume 4 – EU Guidelines to Good Manufacturing Practice Medicinal Products for Human and veterinary Use, Chapter 1-9., European Commission, Enterprise and industry Directorate-General, 2005.
EudraLex, The rules governing medicinal products in the European Union, Annex 2 – Manufacture of biological medicinal products for human use, European Commission, Enterprise and industry Directorate-General, 2005.
EudraLex, The rules governing medicinal products in the European Union, Annex 14 – Manufacture of medicinal products derived from human blood or plasma, European Commission, Enterprise Directorate-General, Working Party on Control of Medicines and Inspections, 2000.
ISO Guidelines for quality and/or environmental management systems auditing (ISO 19011).
Council of Europe
Recommendation No. R(95) 15 of the Committee of Ministers to Member States on the Preparation, Use and Quality Assurance of Blood Components.
European Directorate for the Quality of Medicines & HealthCare (EDQM), European Committee (Partial Agreement) on Blood Transfusion (CD-P-TS), (Ed. Council of Europe). Guide to the preparation, use and quality assurance of blood components. 14th Edition, 2008.
World Health Organisation
World Health Organisation, The Clinical Use of Blood – Aide Memoire, Part 1: Principles, products and procedures, Part 2: Transfusion in clinical practice, Part 3: The appropriate use of blood, 2005
World Health Organisation, Quality Management Training for Blood Transfusion Services, Facilitator’s Toolkit, WHO/EHT/04.13, 2004
Professional Societies or Projects in the field of blood, tissue and cells
European Union Standards and Training in the Inspection of Tissue Establishments (EUSTITE) – European Public Health Programme co-funded Project, Grant Agreement No 2005204. Guidelines for the Inspection of Tissue and Cell Procurement and Tissue Establishments, 1st Edition, 2007
Pharmaceutical Inspection Convention/ Pharmaceutical Inspection Co-operation Scheme (PIC/PICS) PIC/S GMP Guide for blood establishments, PE-005-3, 25. September 2007
PIC/S Standard Operating Procedure (pi 026-1 October 2006) Qualification and training of inspectors in the field of human blood, tissues and cells.
Joint Accreditation Committee of the ISCT and EBMT (JACIE). Accreditation Manual: Haematopoetic Progenitor Cell Collection, Processing and Transplantation. Version 2.0, 2005