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chemistry, manufacturing and control information for human gene therapy investigational new drug applications.(2004 – draft guidance)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) Chapter <63> monograph (Mycoplasma Tests)
- 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.
Not a Member?
Moredun membership allows you to keep up to date with the latest advances in livestock health. You can join or renew your Moredun membership online.