International Regulatory Guidance

Food and Drug Administration (FDA) Guidelines

• Characterization and qualification of cell substrates and other biological starting materials used in the production of viral vaccines for the prevention and treatment of infectious diseases.(2010 guidance) 
• Content and review of chemistry, manufacturing and control information for human gene therapy investigational new drug applications.(2004 – draft guidance)
• Monoclonal antibodies used as reagents in drug manufacture. (2001 guidance) 
• Points to consider in the manufacture and testing of monoclonal antibody products for human use. (1997 guidance) 
• Points to consider in the characterization of cell lines used to produce biologicals. (1993 guidance)
• Points to consider in the production and testing of new drugs and biologicals produced by recombinant DNA technology. (guidance 1985)
• US Code of Federal Regulations  21 CFR 610.12 (Sterility)
• US Code of Federal Regulations  21 CFR 610.30 (Mycoplasma)
• United States Pharmacopeia (USP 24 Microbiological Tests)

International Conference on Harmonisation (ICH) Guidelines

• Q5A : Viral safety of biotechnology products derived from cell lines of human or animal origin.(guidance 1998)
• Q5D : Derivation and characterisation of cell substrates used for production of biotechnological/biological products. (guidance 1997)

World Health Organisation (WHO) Guidelines

• Recommendations for the evaluation of animal cell cultures as substrates for the manufacture of biological medicinal products and the characterization of cell banks. (guidance 2009)

 European Medicines Agency (EMEA) Guidelines

• European Pharmacopeia 2.6.1 Sterility
• European Pharmacopoeia 2.6.2  Mycobacteria
• European Pharmacopoeia 2.6.7 Mycoplasmas
• European Pharmacopoeia 2.6.16. Tests for extraneous agents in viral vaccines for human use.