Milton V. Marshall, PhD, DABT, CCRP
Marshall & Associates
Abstract: Preclinical testing of investigational pharmaceuticals, medical devices, and biologics is necessary before human subjects can be exposed to them. Many similarities exist between the Good Laboratory Practice (GLP) regulations (21 CFR Part 58) and the Good Clinical Practice (GCP) Guidelines (International Conference on Harmonisation E6 Good Clinical Practices), such as the requirement for a protocol, training documentation, and data retention. Differences also exist, such as the level of detail written in the requirements or whether adherence is mandatory. This article compares GLP regulations and GCP guidance, which have similar objectives: to determine the safety and efficacy of the product and document the study results for subsequent study reconstruction.
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