2nd Good Laboratory Practice Compliance Monitoring Summit from January 26-27, 2017
Good Laboratory Practice (GLP) is a data quality system in place to ensure the uniformity, consistency, reliability and reproducibility of preclinical studies in laboratories and organizations conducting research. Prior to clinical trials (where laboratories and pharmaceutical companies are subject to Good Clinical Practice (GCP)), non-clinical health and environmental safety studies are planned, performed, monitored, recorded, archived and reported according to GLP regulations. While there is no specific certification or accreditation issued by a regulatory body in the United States, laboratories are subject to an FDA audit if a study looks to not be compliant with GLP.
GLP regulations were created in response to a lack of consistency and quality in the conduct of studies performed to assess the safety of chemicals that humans might be exposed to, as well as the safety of drugs prior to initiation of first-in-human…
View original post 296 more words