About the Author
Proxima CRO Team
Isabella Schmitt, MBA, RAC
Director of Regulatory Affairs
Ms. Schmitt has also served in additional regulatory affairs and clinical research roles in which she contributed to multiple regulatory submissions and clinical affairs projects across a wide range of indications.

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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