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References

  • 1
    Commission Directive 2003/94/EC of 8 October 2003 laying down the principles and guidelines of good manufacturing practice in respect of medicinal products for human use and investigational medicinal products for human use. Official Journal of the European Union 2003; OJ L 262, 14.10.2003, p. 22
  • 2
    Statutory Instrument 2005 No. 50: Blood Safety and Quality Regulations 2005. London, Her Majesty’s Stationary Office, 2005
  • 3
    International Standards for Cellular Therapy Product Collection, Processing and Administration. Foundation for the Accreditation of Cellular Therapy (FACT) and Joint Accreditation Committee – ISCT and EBMT (JACIE), Barcelona 2008
  • 4
    Standards for the Medical Laboratory. Clinical Pathology Accreditation (UK) Ltd, Sheffield
  • 5
    European Federation for Immunogenetics, Leiden University Medical Centre, The Netherlands. http://www.efiweb.org/contact.html
  • 6
    Legal; Directions Published by Human Tissues Authority, Finlaison House, 15-17 Furnival Street, London, EC4A 1AB http://www.HTA.org
  • 7
    Slopecki A, Smith K, Moore S: The Value of Good Pharmaceutical Manufacturing Practice to a Blood Service in Managing the delivery of Quality. Vox Sang 2007; 92:187196
  • 8
    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; OJ L 256, 1.10.2005, p.41.
  • 9
    Department of Health and Social Security, Ministry of Agriculture, Fisheries and Food, Scottish Home and Health Department, Department of Agriculture and Fisheries for Scotland, Welsh Office, Ministry of Health and Social Services for Northern Ireland, Ministry of Agriculture for Northern Ireland: Guide to Good Pharmaceutical Manufacturing Practice, ed 1. London, Her Majesty’s Stationary Office, 1971
  • 10
    Department of Health and Social Security, Ministry of Agriculture, Fisheries and Food, Scottish Home and Health Department, Department of Agriculture and Fisheries for Scotland, Welsh Office, Ministry of Health and Social Services for Northern Ireland, Ministry of Agriculture for Northern Ireland: Guide to Good Pharmaceutical Manufacturing Practice, ed 2. London, Her Majesty’s Stationary Office, 1977
  • 11
    Medicines Commission Agency: Rules and Guidance for Pharmaceutical Manufacturers 1993. London, Her Majesty’s Stationary Office, 1993
  • 12
  • 13
    Beckman N, Nicholson G, Ashford M, Hambleton R: Blood pack fault monitoring. Vox Sang 2004; 87:272279
  • 14
    Barbara J, Ramskill S, Perry K, Parry J, Nightingale M: The National Blood Service (England) Approach to Evaluation of Kits for Detecting Infectious Agents. Transfus Med Rev 2007; 21:147158