When is GLP compliance required?

Generally, most non-clinical studies fall under the requirements of the GLP regulation. However, there are some instances or stages in the early pre-clinical phase where compliance with GLP is not required. Examples of studies that may be exempt from GLP include exploratory genotoxicity, mutagenicity, safety pharmacology and general in-vitro toxicology studies.

Sponsors may decide to conduct this phase of the study outside of GLP requirements if the goal is to investigate initial drug safety by analyzing only the absorption, distribution, metabolism, and elimination (ADME) properties of the drug. The purpose of this study will be to test the initial tolerability of the drug in different systems. This will then lead to further investigation which is conducted in a study where compliance with GLP is required. Examples of studies that require GLP compliance include standard repeat dose toxicity, genotoxicity and safety pharmacology studies. Finally, the results of all non-clinical trials that will be submitted with an IND must be conducted in accordance with GLP requirements.

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