1. EU Commission of the European Communities (1998) The Rules Governing Medical Products in the European Community, Good Manufacturing Practice for Medicinal Products, Volume IV, April 1998, ISBN 9289–20297, with additional Annexes and update of legal references, July 2004.
2. European Union (2004) Directive 2004/23/EC of the European Parliament and the Council of 31 March 2004 on setting standards of quality and safety for the donation, processing, preservation, storage and distribution of human tissues and cells. Official Journal of the European Union, L102:48–58.
3. US Food and Drugs Administration (2004a) 21 CFR Parts 16, 1270 and 1271. Current Good Tissue Practice for Human Cell, Tissue, and Cellular and Tissue-Based Products Establishments; Inspection and Enforcement; Final Rule. Department of Health and Human Services, November 24.
4. US Food and Drug Administration (2004b) Title 21, Code of Federal Regulations, Part 210, Current Good Manufacturing Practice in Manufacturing, Processing, Packing, or Holding of Drugs; General, US FDA.
5. US Food and Drug Administration (2004c) Title 21, Code of Federal Regulations, Part 211, Current Good Manufacturing Practice for Finished Pharmaceuticals, US FDA. US.