Background and Relevance of Good Laboratory Practices (GLPs) 

Good Laboratory Practices (GLPs) are federal regulations that describe the minimum requirements for conducting studies that support or are intended to support research or marketing permits for products regulated by the Food and Drug Administration (FDA) or Environmental Protection Agency (EPA). The primary intent of the GLPs is to ensure data quality, integrity, and reproducibility. To support this intent, the GLPs direct several conditions under which studies are initiated, planned, performed, monitored, recorded, and reported. To name selected examples, meeting regulatory requirements requires a clear personnel organization, documented and approved methods to conduct a study (a study protocol(s), facility Standard Operating Procedures (SOPs)), an independent monitoring entity (quality assurance unit), a comprehensive approach to data documentation and archival of study data.

The FDA GLPs are applicable to the following types of studies:

  • Safety Studies (mammalian toxicology, metabolism, mutagenicity)
  • Human pharmaceuticals
  • Food/color additives
  • Animal food additives
  • Animal drugs
  • Human medical devices
  • Efficacy under the ‘animal rule’