1. Code of Federal Regulations Federal law relating to biological products http://www.access.gpo.gov/cgi-bin
2. FDA 2012 Guidance for industry: for the submission of chemistry, manufacturing and controls and establishment description information for human plasma-derived biological products, animal plasma or serum-derived products http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/Blood/ucm077102.htm
3. FDA Points to consider relating to recombinant products http://www.fda.gov/cber/guidelines.htm
4. Regulatory affairs and biotechnology in Europe: III. Introduction into good regulatory practice-validation of virus removal and inactivation;Trijzelaar;Biotherapy,1993
5. Vargo , S. A. 1988 U. S. Experience of Regulation and Inspection Conference on Quality Assurance in the Manufacture of Products Derived from Biotechnology