The Basics of Laboratory Investigations

The objective of Current Good Manufacturing Practices (cGMP) is to control the quality of pharmaceutical products, and therefore the purpose of laboratory investigations in a cGMP environment is to identify how adverse events that occur during the manufacture of products can impact on the safety, quality and efficacy of those products. During laboratory testing, sometimes out of specification (OOS), unexpected and suspect results are obtained. Events which cause a deviation from established laboratory procedures can also happen.