Good Laboratory Practices for Nonclinical Laboratory Studies
The U.S. Food and Drug Administration (FDA) is announcing revisions for good laboratory practices (GLP) applied in nonclinical lab studies, particularly in multisite studies, to improve all aspects of study protocol. FDA proposes the integration of a GLP Quality System, a strategy that requires additional capacities for management roles and for facilities to maintain standard operation procedures (SOPs). According to a Federal Register, the rule is also being issued as a result of technological progress that allows for more humane methods of conduct, including the application of the “3Rs” convention to “reduce, refine, and replace animal use in testing.”
Nonclinical laboratory studies are FDA-regulated and work to help the agency make informed decisions about the safety and toxicity of regulated products. These studies are also done to ensure the accuracy and validity of data generation and analysis before testing on human subjects. FDA hopes that the GLP Quality System will provide a more complete set of rules for facilities and become the new standard for organizational structure in nonclinical laboratory studies.
FDA is opening a 90-day comment period for the proposed rule, ending on November 22, 2016. Submissions may be submitted electronically or in writing.
|Good Laboratory Practice for Nonclinical Laboratory Studies|