Good Laboratory Practice (GLP)
The Health Care Inspectorate is responsible for monitoring compliance with the Principles of Good Laboratory Practice (GLP) in the Netherlands. GLP is a quality system which applies to preclinical safety studies on chemicals, pharmaceuticals, veterinary medicines, pesticides and biocides.
Manufacturers are obliged to conduct (or commission) such studies in order to demonstrate the safety of a product to the relevant receiving/regulatory authority, such as the Medicines Evaluation Board in the Netherlands. Only then will a new product or substance be granted a marketing authorization allowing it to be distributed through the regular channels. Safety studies serve to establish that the product poses no risk to human health, animal health and/or the environment.
Purpose of the Principles of GLP is
Purpose of the Principles of GLP is:
- to promote the quality of test data;
- to avoid duplication of research;
- to improve the protection of human health and environment;
- to facilitate international acceptance of test data;
- to prevent the creation of technical trade barriers.
The Principles of GLP were first published in 1982 by the Organization for Economic Cooperation and Development (OECD). Since then, the European Commission has incorporated the principles into binding legislation, see Directive 2004/10/EC. Dutch legislation refers to this Directive.