Laboratory Biosafety and Good Laboratory Practices

In order to ensure biosafety, comprehensive guidelines have been prepared by the National Institutes of Health (NIH) and the World Health Organization (WHO). Both the NIH and the WHO guidelines recommend classification of biological agents based on their potential to cause harm to humans, animals, and the environment. Four Biosafety Levels are recommended to handle organisms of increasing risk potential. Recommended for each level are standard microbiological practices as well as facilities for physical and biological containment of genetically modified organisms (microbes, plants, or animals). In order to harmonize toxicity testing and generation of mutually acceptable preclinical data that may be used for decisions regarding regulation including commercialization, several countries have adopted the principles of Good Laboratory Practices. These principles establish a framework and a minimum standard for the conduct of tests and documentation and analysis of data.