Glossary of Terms
Good Laboratory Practice (GLP)
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About the Author
Proxima CRO Team
Isabella Schmitt, RAC
Director of Regulatory Affairs

Prior to joining Proxima, Isabella served as the Senior Regulatory & Quality Manager at a medical device company, where she outlined the regulatory strategy & put together design controls & design history documentation. She was the Dir. of CMC & Quality at a biopharmaceutical company, where she oversaw all manufacturing and analytical processes and timelines and ensured CMC regulatory strategy was sufficient for filings in Europe and the US.

Good Laboratory Practice (GLP) is a quality system of management controls that is used by research laboratories and organizations to ensure the uniformity, consistency, reliability, reproducibility, quality, and integrity of products that pertain to human or animal health (including pharmaceuticals) through the use of non-clinical safety tests. These tests can range from the analysis of physio-chemical properties to acute to chronic toxicity tests. FDA requires researchers to use GLP, as defined in the medical product development regulations for preclinical laboratory studies. GLP principles also aim to ensure the safety, consistency, quality, and reliability of chemicals that are used in the process of non-clinical and laboratory testing. GLP applies to chemicals, as well as medical devices, food additives, food packaging, colour additives, and other non-pharmaceutical products or ingredients. This quality system is concerned with the organizational process and conditions under which non-clinical health and environmental safety studies are planned, performed, monitored, recorded, archived and reported.

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