Good Laboratory Practice (GLP)

The quality standard for nonclinical safety studies submitted to support marketing approval applications. For drugs in Japan it is the Ministerial Ordinance on Good Laboratory Practice for Nonclinical Safety Studies of Drugs (MHW Ordinance No. 21 of 1997), amended in 2008 to align with international practice, including OECD principles for multi-site studies. Toxicity studies and the core battery of safety pharmacology studies, such as hERG assays submitted for approval, are in principle run under GLP. Japanese documents use the English abbreviation. GLP governs how a study is planned, performed, recorded and archived; it does not judge whether the study design answers the safety question.