cGLP Regulations

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Welcome to GLP Guide

GLP, or cGLP, stands for current Good Laboratory Practice, and is a set of regulations set forth by the Food and Drug Administration (FDA) and the Environmental Protection Agency (EPA) to help ensure that the processes and conditions under which laboratory studies are planned, performed, monitored, recorded and reported are are valid and high-quality.

Is Your Facility GLP Compliant for 2012?

GLP regulations describe the minimal standards for conducting nonclinical laboratory studies that support applications for research or marketing permits for products regulated by FDA or EPA such as human drugs, animal drugs, food color additives, fragrances, medical devices, biological products, and pesticide products. The regulations do not pertain to studies using humans.

GLP compliance is determined by regulatory inspections similar to those conducted to assess Good Manufacturing Practices (GMP) compliance. The main distinction between GLP and GMP is that GLPs are study-based methodologies whereas GMPs are processed-based methodologies.

GLP regulations are set forth in the FDA Federal Code of Regulations 21 CFR Part 58. Preclinical trials on animals in the United States of America use these rules prior to clinical research in humans. Research in the US not conducted under these restrictions or research done outside US not conducted according to the OECD Guidelines (or FDA rules) might be inadmissible in support of a New Drug Application in the US.