What Does Good Laboratory Practice Mean?

• Date: November 04, 2009

Good Laboratory Practice, a regulation instituted in 1978, intended to regulate non-clinical laboratory safety studies. The outcome of these studies gave researchers the insight into safety of the new molecular entities for human trials or clinical trials.

The main laboratories that were affected by the regulation were ones conducting clinical chemistry, histology and pathology, which are used to analyze the samples generated from toxicology studies.

What are the aims of GLP? What are the key differentiators from other regulations? What are the various GLP organizational roles and their responsibilities?