ABSTRACT

To explore the question given to the author of this chapter “how can GAMP 4 be applied to GLP?” we must first confirm our definition of GLP (Good Laboratory Practice) and quickly eliminate some common misunderstandings. The term GLP refers explicitly to laws concerning the area of investigation where toxicology and safety studies on chemicals are carried out — which may include animal and other in vivo and in vitro testing. This work is performed in the so-called preclinical (or nonclinical) phase of drug product development in the pharmaceutical industry — but toxicology testing is also carried out in the industrial chemicals and defence and military sectors. The key defining aspects of this type of regulated work are chemical and biochemical analysis. This sometimes involves animal testing carried out in laboratories and other controlled areas, performed on chemicals and new molecular entities (which may become medicinal, therapeutic, cosmetic, or industrial products) to determine toxicity and safety data using explicit and implicit

scientific and ethical approaches named the “Principles of GLP” [1]. Often, but not always, the work in GLP areas of the pharmaceutical sector is on new compounds not yet approved for use in humans or animals.