Standards used for biological-biotechnological products

• Good Manufacturing Practices for Biological Products (Technical Report Series No. 822, 1992, Annex 1)
• General Requirements for the Sterility of Biological Substances (Technical Report Series No. 530, 1973, Annex 4, Technical Report Series No. 872, 1998, Annex 3)
• Good Manufacturing Practices for Pharmaceutical Products (Technical Report Series No. 823, 1992, Annex 1)
• Guidelines for National Authorities on Quality Assurance for Biological Products (Technical Report Series No. 822, 1992, Annex 1) (Technical Report Series No.822, 1992, Annex 1)
• Regulation and Licensing of Biological Products in Countries with Newly Developed Regulatory Authorities (Technical Report Series No. 858, 1994, Annex 1)(Tehnical Report Series No. 858, 1994, Annex 1)
• Requirements for the Use of Animal Cells as In Vitro Substrates for the Production of Biologicals(Technical Report Series No. 878, 1998, Annex 1, Technical Report Series No 927, 2005, Annex 4)
• Guidelines for Assuring the Quality of Pharmaceutical and Biological Products Prepared by Recombinant DNA Technology (Technical Report Series No. 814, 1991, Annex 3)
• Recommendations for the Production, Control, and Regulation of Human Plasma for Fractionation
• WHO Requirements for the Collection, Processing, and Quality Control of Blood, Blood Components, and Plasma Derivatives (Technical Report Series No. 840, 1994, Annex 2)
• Guidelines on Viral Inactivation and Removal Procedures Intended to Assure the Viral Safety of Human Blood Plasma Products (Technical Report Series No. 924, 2004, Annex 4)
• Guidelines on the International Packaging and Shipping of Vaccines (WHO/IVB/05.23, 2005)
• WHO Guidelines On Transmissible Spongiform Encephalopathies in Relation to Biological And Pharmaceutical Products